Newsletter_12-2022_EN

www.reinraum.de 

NEWSLETTER 

www.cleanroom-online.com Edition EN 12-2022 

© Messe Frankfurt Exhibition GmbH / Jean-Luc Valentin 

Ten years of Cleanzone: 

Fulminant restart for the 

anniversary edition in 2022 

In addition to the exhibitors‘ products and solutions, the highlights at Cleanzone 2022 included the top 

themes of automation, sustainability and the challenge of supply chains. The top themes were discussed 

intensively during the Cleanzone Conference. Both the exhibitors and the nominees for the Cleanzone 

Award presented their innovations in interdisciplinary cleanroom technology in Frankfurt am Main on 

23 and 24 November. 1,500 participants and 82 exhibiting companies came to the Cleanzone anniversary 

edition, which not only grew in terms of space. 

Full of energy, with numerous ideas, products and innovations for a wide range of applications, the international 

cleanroom industry met in Hall 1.2 at the Frankfurt Fair and Exhibition Centre for Cleanzone, the international 

trade fair for cleanroom and cleanliness technology, hygiene and contamination control. But more 

than that, there was occasion to celebrate. Wolfgang Marzin, Chairman of the Board of Management of Messe 

Frankfurt: „Ten years of Cleanzone – what an impressive anniversary edition. The trade fair has once again proven 

that the subject of cleanroom technology is innovative, important and relevant for the future. The number 

of different industries, innovations and impulses for the future presented here is remarkable. It‘s great to see 

how new things can be created here on site.“ 

The industry‘s solutions are in demand: starting with the needs for both the production of filters and protective 

clothing, the development of medicines, the demand for increased hygiene measures and comprehensive 

contamination control – these topics have come strongly to the fore not only since the Corona pandemic. One 

of the major topics among the participants was also the question of solutions helping to avoid production 

stops in times of crisis. Cleanzone provided the answers here. This is also reflected in the visitor survey, with 

results for Cleanzone 2022 significantly higher than those of the previous event in 2019: 91% of visitors showed 

overall satisfaction with Cleanzone 2022 (2019: 85%), 87% of visitors are satisfied with the range of products and 

services on display (2019: 84%) and 46% of visitors are planning to invest in cleanroom technology (2019: 46%). 

Cleanzone Conference: Making the future tangible 

The focus of the Cleanzone Conference was primarily on the top issues: Here, information and discussions were 

held on automation and supply chains, compliance and QMR as well as new standards and modern cleanroom 

Page 1/42


NEWSLETTER 

www.cleanroom-online.com Edition EN 12-2022 | Page 2/42 

concepts. The topic of sustainability was addressed in presentations 

such as „Delivering energy efficiency solutions in pharmaceutical and 

life science cleanrooms“ by Keith Beattie (EECO2), „Towards holistic 

sustainability through circular economy“ by Prof. Dr. Julia Krause (HTW 

Dresden) and „Sustainability and Contamination Control in Hospitals“ 

by MSc. Remko Noor (Maximuse B. V.). In the lecture „Personalized Medicine 

– Chances and Challenges“, Morten Schlothauer also spoke about 

the relevance of patient-specific drug manufacturing. In addition, 

lectures on intralogistics, diversity and the promotion of young talent 

in the cleanroom sector also proved to be a magnet. A total of 22 renowned 

experts shared their know-how with Cleanzone participants 

and facilitated exchange on current challenges. 

The number of exhibitors also increased for the anniversary edition. 

82 exhibitors from 17 countries exhibited at Cleanzone. A total of 1.500 

participants from 38 countries visited the trade fair (2019: 1,300 participants 

from 42 countries). Besides Germany, the most important visitor 

countries were the Netherlands, Türkiye, Switzerland, Ireland, France, 

Great Britain, Italy, Austria, the Czech Republic and Sweden. The degree 

of internationality of the visitors reached about 30 per cent. Most 

of the trade visitors came from the pharmaceutical industry, microelectronics 

and biotechnology. 

Cleanzone will be held every two years in future. The next edition will 

take place on 25 and 26 September 2024 in Frankfurt am Main. 

And the Cleanzone Award goes to… 

Out of eleven applications submitted, five prevailed for the Cleanzone 

Award 2022 and were ultimately nominated for the prize by the expert 

jury. In the end, the Cleanzone Award 2022 was awarded to Reinraum- 

Mieten with the innovation “Cleanroom Rental”. The project provides 

temporary, individually configurable cleanrooms and in the end convinced 

the jury and the trade fair audience. Reinraum-Mieten receives 

an award and 3,000 euros for its innovation from Wiley publishing 

house, Cleanzone partner. 

cleanzone 

Messe Frankfurt Exhibition GmbH 

Ludwig-Erhard-Anlage 1 

D 60327 Frankfurt am Main 

Telefon: +49 69 7575 6290 Telefax: +49 69 7575 96290 

eMail: anja.diete@messefrankfurt.com 

Internet: https://cleanzone.messefrankfurt.com 

DECEMBER 2022 

Dear cleanroom professionals, 

A few interesting and informative days lie behind us. We were exhibitors at Cleanzone, 

which celebrated its 10th anniversary this year. 

To sum up for all those who were not there and for all quick readers: our highlight was not 

the yellow Aston Martin on our stand, but the new directory of REINRAUM EXPERTEN. On 

240 pages we now offer a clear compilation to all those who are looking for REINRAUM 

EXPERTEN. You can read more about this on the following pages. 

If you are looking for an EXPERT but have not been to Cleanzone, you can easily request 

the EXPERT directory by eMail. We will send it with invoice for a flat rate of 10 Euro (DE)/ 

15 Euro (INT) including packaging and shipping by post. eMail to: info@reinraum.de. 

Scan 

or kick 

to the movie 

In the meantime you can read the new newsletter with current information. 

> Ten years of Cleanzone: Fulminant restart for the anniversary edition in 2022 

> Overall impact of new Annex 1 in pharmaceutical industry 

> Sensational and innovative as ever 

> Reliable and sustainable process for cleaning high-tech components 

in cleanrooms 

> Advanced Bio-decontamination with Vaporized Hydrogen Peroxide 

> Standards are here to stay 

> Clean Communication: SEMI Standards 

> . . . 

I wish you interesting reading. 

With kind regards 

Reinhold Schuster


NEWSLETTER 


Overall impact of new Annex 1 

in pharmaceutical industry 

Annex 1 and sterilization process: an interview with Tim Sandle 

The revision of Annex 1 is requiring a major effort from the life sciences industry; from ‘setting up new processes, to training staff, to managing 

noncompliance, the industry needs to adapt particularly to new requirements regarding contamination control strategy and the 

essential elements needed to develop a robust sterility assurance system. 

One of the most discussed processes involves autoclaving and the risks associated with it. 

We talked about it with Tim Sandle, a microbiologist, author and science journalist, known as one of the leading experts in the field. 

Our interview opens with an assessment of the overall impact of the 

new Annex 1 on contamination control strategies in the pharmaceutical 

industry. Dr. Tim Sandle, the new Annex 1 revision is distinguished 

by a “holistic” view of contamination control. What are the most 

immediate consequences of this new approach? 

Many facilities have developed approaches to contamination control, 

but the call within the Annex is for pulling everything together to 

provide a holistic overview of the facility, the rationale, the gaps, the 

level of risk for each gap, and the remediation steps. A contamination 

control strategy is a system that considers all the integral elements of 

pharmaceutical product manufacturing. This is best achieved using 

quality risk management principles and supporting risk assessments 

for contamination control and monitoring (the detectability of contamination 

event). 

As a governing ethos, processes, equipment, facilities and manufacturing 

activities should be managed in accordance with risk management 

principles that provide a proactive means of identifying, 

scientifically evaluating and controlling potential risks to quality. 

The strategy at each facility will vary, but common themes will 

include: microbial contamination, cleaning and disinfection, sterility 

assurance, facility design, chemical and particle contamination. 

Outside of the microbial, other forms of contamination that can 

arise from mix-ups, damaging primary or secondary packaging, distribution 

problems, and environmental fluctuations. Overall, a focus will 

need to be with reducing contamination likelihood and cross-contamination 

potentials. This needs science and technical procedures and 

controls. 

The format would be as one document or series of connected documents 

developed to reflect the site-wide strategy for minimizing 

contamination control. 

Importantly, the strategy should be a living document and be updated 

in relation to change controls, process development, recurrent 

deviations and in relation to other quality records. 

Challenges in sterilization processes 

What are the challenges facing the pharmaceutical industry 

in sterilization processes with respect to the requirements of 

the new Annex1? 

Perhaps the most significant change is in relation to equipment sterilization 

when used for aseptic processing. The 2017 draft stated that critical 

surfaces with direct impact need to be sterilized (such as a filling 

manifold or stopper bowl); however, with the 2020 revision this now 

requires direct and indirect contact parts to be sterilized. This could 

present challenges to facilities with both isolators and RABS devices. 

There is a specific update for freeze-dried products in terms of 

freeze-dryers (or lyophilizers). This is for lyophilizers which are manually 

loaded or manually unloaded. Here the freeze-dryers should be 

sterilized before each load. 

Other important Annex 1 points include the requirement that the 

feed water to a pure steam (clean steam) generator should be appropriately 

purified, to achieve the required chemical and endotoxin 

levels, as assessed by the Water-for-Injections pharmacopeial monitoring 

and testing requirements. With the chemical requirement, this 

is because steam used as a direct sterilizing agent must not contain 

additives at a level which could cause contamination of product or 

equipment. This part of the process needs to be validated. The steam 

must also consistently meet the parameters for non-condensable gases, 

dryness value (dryness fraction) and superheat. 

The Annex also specifies that each item sterilized needs be inspected 

for damage, packaging material integrity and moisture on removal 

from the autoclave. Any item found not to be fit for purpose, either damaged 

or where there is evidence of a ‘wet load’, should be removed 

from the manufacturing area and an investigation performed.


NEWSLETTER 


On the subject of wet loads, this is the most worrying factor. When 

steam enters the autoclave chamber and contacts with the product, it 

is important that the steam collapses (condenses) on the product. This 

is in order for the heat to be released to the load. However, the formation 

of water must be discharged through condensate management 

or re-vaporized in order to prevent contamination of the product. Removal 

of the excess water is important to prevent insulation of the 

load from the steam. 

We also need to be mindful of pressure and its relationship to 

temperature. Given that autoclaves destroy microorganisms by direct 

steam contact at the required temperature and pressure for a specified 

time, pressure control is important. Poor pressure control can 

cause variations in steam velocities. 

Critical issues in autoclave sterilization 

What are the main critical issues in autoclave sterilization processes? 

Some of the key issues are based on the failure modes. Understanding 

these modes is important for controlling the critical issues. One that 

stands out is load design. Many companies will use a matrix approach, 

whereby worst case load configurations are validated with a view to 

allowing other load combinations to be used without undergoing 

validation. Here care must be taken with the design of the matrix so 

that anything relating to the load that can affect the distribution of 

the incoming steam or which can affect uniformity of temperature is 

identified and accounted for. The assessment should also take into account 

anything that can take heat away from the chamber can affect 

temperature uniformity. 

Often mass is used for the matrix. However, there are other factors 

that can affect sterilization. These include the shape of the equipment, 

where narrow pipework or hoses presents a particular challenge in 

terms of steam penetration (here center of the length of hose is the 

most difficult to sterilize); whereas with worst-case location within a 

bottle, flask or cylinder the worst case is the center near the bottom 

of the container. 

The orientation of the equipment is also important, and this affects 

whether the item is capable of free-draining. Where there is uncertainty 

about what constitutes worst case some initial work can be 

undertaken thermometrically (heat penetration evaluation tests); this 

allows data to be collected about heat distribution, and this ‘hard to 

heat’ study is generally recommended. Account should be taken, with 

liquid loads, oft the viscosity of the liquid since this can affect heat 

penetration. 

A further factor is the type of material, such as elastomeric materials 

and stainless steel. If these types of materials are used in combination, 

then a balance of both may be needed for the worst case. However, if 

in practice the materials are sterilized separately, this may prompt two 

types of worst case loads. 

Materials: risks of medical paper and Tyvek® advantages 

Let’s talk about materials: despite the strong presence of cellulose, 

many continue to use medical paper. What are the risks and how, 

with the new Annex 1 is it necessary to deal with them? 

Packaging materials, used to wrap the items to be sterilized, are 

probably one of the most important parts of the sterilization process. 

Packaging provides a protective barrier for the sterile item and prevents 

it from becoming re-contaminated. When used in aseptic processing, 

the packaging should be of low particle generation. 

Cellulosic paper is not suitable for higher grade cleanrooms, especially 

due to the potential for fibers to be released. Annex 1 emphasizes 

that products need to be free of visible particulates. Non-autoclaved 

cellulosic paper is also probe to microbial contamination, given 

the range of microbes that are capable of cellulose hydrolysis. 

An alternative is Tyvek® and Tyvek®/PET-PP. Tyvek® material is 

made of continuous strong fibers of pure high-density polyethylene, 

is low linting and free of inherent contaminants that could represent 

a risk in critical environments. Tyvek® retains its dimensional stability 

and integrity and maintains its tensile strength, microbial barrier and 

the required air permeability to enable effective sterilization. 

In making the correct choice, packaging needs to be well designed 

and of sufficient porosity so that steam can pass through packaging. 

In addition, packaging should be water repellent to provide a 

sterile “field.” Furthermore, the packaging material must not change 

significantly during sterilization or release any substances that might 

interfere with the action of the steam. 

Autoclave load validation processes 

New Annex 1 requirements will force pharmaceutical manufacturers 

to revise their autoclave load validation processes. 

Validation needs to be designed carefully to avoid failures (or failures 

with re-validation). The Annex expects a greater level of detail 

and investigation. Failure to inactivate biological indicators is normally 

due to inadequate air removal rather than inadequate conditions of


NEWSLETTER 


temperature and time. 

Sometimes failures of re-validation can be attributed to using biological 

indicators with much higher D-values than those used for the 

initial validation (where the biological indicators used for the re-validation 

have a far higher resistance compared with those used for the 

initial qualification. This could occur, for example, if the initial qualification 

was performed using a biological indicator with a D-value of 1.5 

minutes and the re-qualification executed using a biological indicator 

with a D-value of 3.0 minutes). 

Issues can also arise due to changes to load patterns. How load 

patterns are assessed such as mass compared with item complexity 

and configuration, as with tubing. 

One issue will be the requirement to more carefully assess the 

quality of pure steam. There is also a materials piece, in that before 

any sterilization process is adopted, the suitability for the product or 

equipment need to be assessed to make sure it is suitable for the desired 

sterilizing conditions. 

Another factor is with the design of the load, as I’ve previously 

mentioned. Other considerations for the validation design include 

handling items of a shape where there is the potential for trapped air 

(and thus difficulties with air removal). There are also items that may 

not allow steam to penetrate and are thus hard to heat (such as filters, 

check valves, and small tubing). Plus, there are items where there is 

potential for condensate collection. 

It is important to undertaken a careful evaluation, and to set an appropriate 

maximum reprocessing time. 

Conclusions 

We would like to conclude this interview with a quote from the new 

Annex 1. 

§8.60 The items to be sterilized, other than products in sealed containers, 

should be dry, wrapped in a material which allows removal 

of air and penetration of steam and prevents recontamination after 

sterilization. All loaded items should be dry upon removal from the 

sterilizer. Load dryness should be confirmed by visual inspection as a 

part of the sterilization process acceptance. 

The choice of packaging systems becomes of utmost importance 

for proper alignment with the requirements of the new Annex 1. Indeed, 

as is clear from the text, and from the interview with Tim Sandle 

himself, the success of the sterilization cycle depends on several factors 

closely related to the selection of the packaging material: only a 

low degree of particle release, an anti-microbial barrier of maximum 

effectiveness, a bill that allows uniform steam penetration, and last 

but not least tear and puncture resistance can ensure a proper autoclave 

cycle. 

Critical issues of washable products 

How do you evaluate the use of washable products and what, 

if any, critical issues do you see in this type of choice? 

The key issue with washable products is with the number of times 

they can be processed and what the impact of this is upon the life-time 

of the item. Integrity issues and release of particles are two areas 

of concern, along with other forms of structural weaknesses and discoloration. 

This relates not only to the washing process but also to 

sterilization – both are aggressive processes that can affect the material. 

The choice of water and the type of sterilization process and the 

parameters surrounding this represent important choices to be made, 

in order to avoid damage and to extend the reprocessing cycle. 

AM INSTRUMENTS 

Via Isonzo, 1/C 

IT 20812 Limbiate (MB) 

Phone: +39 02 8728421 

email: info@aminstruments.com 

Internet: https://global.aminstruments.com/ 

Dr. Tim Sandle is a pharmaceutical microbiologist, science writer and 

journalist. He is a chartered biologist and holds a first class honours 

degree in Applied Biology; a Masters degree in education; and has a 

doctorate from Keele University. 

Interview by Cristina Masciola, AM Instruments 

– Marketing & Communication Manager


NEWSLETTER 


Sensational and innovative 

as ever 

Reinraum Online at Cleanzone 2022 

Scan 

or kick 

to the movie 

For 10 years now, Reinraum Online has been present at Cleanzone - 

and that is just as long as this trade fair has existed. We are a bit proud 

of that. And the trade fair management also found this worthy of appreciation. 

But in this anniversary year, we seem to have „taken the 

cake“. The bright yellow Aston Martin, which roared up at our stand 

every hour, actually attracted just about every one of the officially registered 

1,500 visitors to our 40 square meter stand. Some of them sat 

down in it with a glowing look and immediately sent their selfie out 

into the world. After all, this was an Aston Martin, DBS Superleggera 

Volante with 725 hp, 5.2 l twin-turbo engine, 0-100 km/h in 3.6 sec., top 

speed 338 km/h in radiant Frosted Glass Yellow and a retail price of 

403,825 Euros. 

But beyond the attention-grabbing trade show tag (what else is the 

point of a trade show presence than to attract visitors‘ attention?) 

Reinraum Online actually had a remarkable novelty to present: The 

printed directory of REINRAUM EXPERTEN. A real book in times of digital 

omnipresence? Yes, because we humans are haptic beings and 

want to have something in our hands. That‘s why Reinraum Online 

offers all those who are looking for EXPERTS for cleanroom solutions 

of all kinds „something to touch“ on 240 pages. 

Flipped, not scrolled. 

Instead of an empty search field on the computer, the searcher is 

guided through a clear table of contents with 13 chapters to the generously 

presented expert profiles. Here, it‘s a breeze to compare the 

individual performance profiles at your leisure and mark them if you‘re 

interested. Anyone who thinks this is old-fashioned has never tried to 

do extensive Internet research without printouts and sticky notes. The 

contact details of the individual providers printed next to the service 

profiles are linked to a QR code that, when scanned, leads directly to 

the ExpertPool on our platform. And here you can then find a wealth 

of further information on the company you are looking for, including 

publications that have already been made with us. The perfect symbiosis 

of analog and digital. Typical cleanroom online.


NEWSLETTER 


This was also understood by the visitors at the Cleanzone booth of 

cleanroom online. Thus it came that quite a few experts, who were not 

represented so far in this unique Compendium, decided now for a registration 

in it. In the future, they too want to take advantage of the year-round 

visibility in this directory of REINRAUM EXPERTEN. That makes 

us very happy, of course. And our „tome“ can take a few more pages. 

Found, not searched for. 

The necessity as well as the sense of such a content-heavy collection 

in book format had become massively apparent to us in the past 

months. Again and again we received calls with the question for a 

proven expert for A, B or C. Indeed, such a highly complex domain as 

the cleanroom with all the guidelines, regulations and standards cannot 

do without documented and addressable EXPERT KNOWLEDGE. 

After all, it is these highly specialized EXPERTS with their very special 

knowledge and technical skills, who ensure the finding of goal-oriented, 

appropriate and method-guided solutions for very special tasks 

and problems. Only if they can be accessed in a targeted manner, these 

EXPERT SOLUTIONS are also available to the market in its growing 

breadth. 

Shaken, not stirred. 

Expert knowledge, at least some cineastic knowledge, was needed 

by the visitors at the booth of Reinraum Online to participate in the 

prize puzzle. For the obvious connection of the exhibited Aston Martin 

to the film legend James Bond had to be unmasked with a little 

rethinking. On the posters draped around the stand, a number of film 

titles had been alienated and visitors were asked to find the correct 

solution. Not too difficult a task, as the lively participation in the competition 

showed. From „The Spy Who Loved Me“, the 10th James Bond 

from 1977, we unceremoniously made „The Germ Who Loved Me“. And 

„Casino Royale“ became „Casino Clean Room.“ A funny thing, as many 

visitors found, who competed for the prizes. There were five times a 

bottle of Martini and one four-piece cocktail set to be won. At the 

draw on the second day of the fair at 2 p.m. at the booth of Reinraum 

Online, three of the winning sets could be handed over directly, two 

more sets will reach the winners by mail. 

We are pleased about what we consider to be a very successful trade 

fair participation with many interesting and encouraging discussions. 

Of course, we are particularly pleased that our publicity activities have 

apparently already led to new business relationships and the conclusion 

of contracts in several cases, as we were told. Our pleasure. 

Reinraum Online 

W.A. Schuster GmbH 

Mozartstraße 45 

D 70180 Stuttgart 

Telefon: +49 711 9640350 Telefax: +49 711 9640366 

info@reinraum.de 

http://www.reinraum.de


NEWSLETTER 


Reliable and 

sustainable process 

for cleaning high-tech 

components in 

cleanrooms 

CO2 snow-jet cleaning for high-purity 

applications 

The number of parts which, due to stricter cleanliness specifications, 

need to be cleaned in a cleanroom is constantly rising - and this is 

true for many branches of industry. In most cases, these tasks cannot 

be solved using classic cleaning methods. Thanks to the sustainable 

quattroClean snow jet technology, however, parts can be cleaned on 

demand with consistent results in a dry process. The cleaning system, 

which is adapted to the respective cleanroom class, can be designed 

as a fully automated system for integration into production lines, or 

as a stand-alone system for partially-automated or manual operation. 

Thanks to the interaction of the effects of the quattroClean snow jet 

technology, particulate contamination down to the submicrometer 

range as well as the finest filmic contamination is removed reliably 

and consistently. (Photo credit: acp systems) 

In more and more industrial sectors, particulate cleanliness specifications 

down to the submicrometer range and exceptionally high filmic cleanliness 

requirements are making it necessary to shift cleaning processes to 

a clean or pure environment. These include tasks such as cleaning metallic 

and optical components - for example, before or after coating - for 

DUV and EUV lithography in the semiconductor supply industry, as well 

as structural parts for geostationary satellites in space technology. During 

microchip production, traces of powder or sawing residues after wafer dicing 

with lasers or diamond saws have to be removed. When it comes to 

sensor technology and electronics, it is parts such as optics and housings 

for assistance systems in vehicles and smartphone cameras that need to 

be exceptionally clean to ensure their lasting and reliable function. In addition, 

contact surfaces need to be cleaned before bonding, as well as 

electronic parts already fitted with components like imagers. In the medical 

device sector and pharmaceutical industry, the safe use of products 

such as implants, instruments and lab-on-chip solutions also depends on 

the cleanliness of the parts. As diverse as these cleaning tasks may be, 

today’s cleanliness specifications can no longer be reliably met with conventional 

processes like compressed air, brush or wet-chemical cleaning.


NEWSLETTER 


Snow for outstanding cleanliness 

The scalable quattroClean snow jet technology from acp systems AG is a cleanroom-compatible 

and proven solution for such tasks. The cleaning process is dry 

and uses liquid, climate-neutral CO2. The key to the reliable cleaning results is the 

design of the wear-free two-substance ring nozzle through which the carbon dioxide 

is fed. On exiting the nozzle, the CO2 expands to form fine snow particles, 

which are then bundled by a separate jacket jet of compressed air and accelerated 

to supersonic speed. The jet is easy to focus on a specific area. On impacting on 

the surface to be cleaned, the four effects (thermal, mechanical, solvent and sublimation) 

of the quattroClean snow-jet technology ensure that particles down to 

the sub-micron range and filmic contaminants are removed effectively and consistently. 

Since the crystalline carbon dioxide sublimates completely during cleaning, 

the surfaces or parts are dry. At the same time, the process is so gentle on materials 

that it can even be used to clean delicate, sensitive and finely-structured surfaces. 

The JetStation-HP, designed and equipped for cleanroom 

use, was developed for flexible cleaning tasks with the highest 

cleanliness requirements. It is loaded manually and can be 

operated in partially or fully automated mode as a standalone 

solution. (Photo credit: acp systems) 

The residual powder formed during wafer dicing with lasers 

is removed effectively by the quattroClean snow jet technology. 

Cleanliness was proven using a digital microscope with marks 

with an external diameter of 0.4 mm. 

(Photo credit: acp systems) 

Process design and system design assure excellent cleaning results 

The process for full-surface or partial cleaning is tailored to requirements through 

tests in acp systems‘ technical center. All process parameters, such as the volume 

flows for compressed air and carbon dioxide, the number of nozzles, the area to be 

jet-cleaned and the jet time, are precisely tailored to the respective application on 

taking material properties, the type of contamination and cleanliness specifications 

into account. These parameters can be filed as part-specific cleaning programs 

in the system control. During cleaning, end-to-end process monitoring and control 

guarantee that each part is cleaned using the validated process parameters. 

The design and features of the modular cleaning systems are adapted to the 

respective cleanroom class. Therefore, they are made entirely of stainless steel and 

have smooth, homogeneous surfaces. The flow-optimized design of the process 

chamber ensures that the detached impurities and sublimated carbon dioxide 

are removed rapidly and effectively by the integrated extraction system. Media 

preparation equipment geared to the task at hand also guarantees that cross-contamination 

and re-contamination are prevented. 

Solutions for integrated, partially-automated and manual cleaning 

To optimally tailor the cleaning solution to the respective requirements and production 

situation, acp systems offers various modular solutions and individually 

planned systems. The compact JetCell-HP was developed for flexible, automated 

cleaning tasks. The plug & play cleaning cell can be easily integrated into connected 

manufacturing environments or operated as a standalone solution. The integrated 

interfaces make it possible to connect the digitally-controllable cleaning system 

to higher-level host computers. All data collected during process monitoring 

and control can be automatically recorded and transferred to the host computer. 

The JetStation-HP is a closed cleaning cell for partially-automated or manual operation. 

With these cleanroom-compatible alternatives, all the technology for the 

snow jet process as well as the media preparation equipment are integrated into 

the system‘s slender housing. The system is put into operation simply by hooking 

it up to the carbon dioxide and compressed air supply. 

The process itself, where all process parameters are precisely 

adapted to the respective application, material properties, 

contamination to be removed and cleanliness specifications, is 

designed in acp systems‘ technical center. 

(Photo credit: acp systems) 

acp systems AG 

Berblingerstraße 8 

D 71254 Ditzingen 

Telefon: 07156 480140 

eMail: mail@acp-systems.com 

Internet: http://acp-systems.com


NEWSLETTER 


Advanced Bio-decontamination with 

Vaporized Hydrogen Peroxide 

TKSAGE (Shenzhen) Technology Group Co., 

Ltd. provides R&D, equipment, and installation 

of cleaning and sterilization technology 

and is committed to providing state-of-theart 

solutions for customers in life science and 

healthcare. Since its establishment in 2008, 

TKSAGE has always regarded product quality 

as top priority. However, with accelerating 

customer demand, TKSAGE faced the challenge 

of further upgrading its products and 

services to meet the needs of more demanding 

application environments, more complex 

use scenarios, and higher measurement 

accuracy requirements. 

The COVID-19 pandemic brought new 

challenges to bio-decontamination applications 

in hospitals, laboratories, and bio-pharmaceutical 

applications. Clean equipment 

and sterilization processes play a pivotal role 

in addressing these challenges. After careful 

research, TKSAGE chose Vaisala’s HPP270 vaporized 

hydrogen peroxide probes as part 

of their bio-decontamination systems used 

in isolators, material transfer chambers, and 

other areas. Using the HPP270 probes has 

allowed TKSAGE to improve the adaptability 

and stability of their bio-decontamination 

solutions by increasing the sensitivity and 

accuracy of vH2O2 measurement and solving 

condensation control issues. 

Enhanced technology for 

vaccine production 

In biopharmaceutical applications, the biosafety 

transfer chamber is a crucial environment 

used to move materials from lower-level 

clean areas to higher-level clean areas. 

During the transfer process, the chamber is 

injected with vaporized hydrogen peroxide 

to decontaminate the surfaces of the materials. 

This mitigates microbial contamination, 

for example, in the preparation process of 

COVID-19 vaccines. 

During the preparation of COVID-19 vaccines, 

the virus is cultured in what is called 

a “protective zone”. To avoid contamination, 

any material entering or leaving this zone 

must be decontaminated. The cleanliness 

requirements of the vaccine ampoule filling 

environment are also extremely high 

and any material entering the environment 

needs to be thoroughly decontaminated. 

“It is the very high cleanliness level requirement 

that provides an ‚application scenario‘ 

for the vaporized hydrogen peroxide 

aseptic transfer chamber, and the Vaisala 

HPP270 sensor further strengthens the quality 

and functionality of the transfer chamber,” 

says Zhu Zhengcai, Technical Director of 

TKSAGE. 

“Compared with traditional electrochemical 

sensors, the HPP270 features higher 

measurement sensitivity, a wider measurement 

range, and innovative functions, while 

ensuring effective bio-decontamination.“ - 

Zhu Zhengcai 

In terms of sensitivity, the HPP270 sensors 

are designed to maintain accuracy in high 

ppm hydrogen peroxide bio-decontamination 

environments. As the vH2O2 concentration 

gradually decreases, the HPP270 performs dynamic 

measurements and provides feedback, 

neither of which is possible with electrochemical 

sensors. Additionally, the measurement 

range of the HPP270 probes is wide. Finally, 

the HPP270 provides a unique measurement 

in the Relative Saturation (RS) value. 

“We can control condensation using the 

relative saturation value, which allows us to 

reduce the risk of corrosion. Before we had 

the HPP270 probes, we needed to use complex 

calculations to figure out the condensation 

point,” says Zhu Zhengcai. “The HPP270 

can directly output this value, a function that 

is not available in other sensors.” 

High tolerance and excellent 

product quality 

In vaporized hydrogen peroxide bio-decon-


NEWSLETTER 


tamination, a given concentration of hydrogen 

peroxide is vaporized, converting the 

disinfectant from liquid to a gaseous state. 

In this way, vH2O2 destroys microorganisms 

that are oxidized by hydrogen peroxide. 

vH2O2 bio-decontamination is effective at 

killing a broad range of microorganisms, including 

bacteria, fungi, molds, viruses, and 

spores, etc. Once the bio-decontamination 

is complete, vH2O2 quickly degrades to H2O 

and O2, making it verifiably non-toxic. 

However, vH2O2 has some side effects. 

First, as a strong oxidizing agent, it can be 

corrosive to certain materials and equipment. 

“Previously, there were no vaporized hydrogen 

peroxide-tolerant temperature and 

humidity sensors on the market.Vaisala developed 

a robust product with a variety of 

test functions... the HPP270 that we are now 

using.” - Zhu Zhengcai 

When a TKSAGE customer in Hainan 

needed to disinfect a high-temperature/ 

high-humidity environment, their sensors 

could only be used for three months before 

they expired. “Vaisala’s HPP270 gives our 

systems a unique condensation control capability. 

This helps us safeguard materials,” 

says Zhu Zhengcai. “We went to the customer’s 

site to test the probes. We found that 

the HPP270’s capabilities, combined with its 

corrosion-resistant stainless-steel housing 

(IP65), allowed the customer to use the probes 

normally for much longer than three 

months. In the end, the customer adopted 

our system.” 

Vaisala’s HPP270 probe series have also 

enhanced TKSAGE’s transfer chamber applications. 

To date, TKSAGE’s market share in 

transfer hatch vH2O2 bio-decontamination 

solutions has been far ahead of its competitors, 

reaching about 70%. 

At the very beginning, [2019] we contacted 

a Vaisala salesperson who impressed us 

as practical and realistic. From contact and 

communication, to understanding of our solutions, 

to testing the HPP270 within our systems, 

the whole process was smooth.” - Zhu 

Zhengcai 

User-friendly bio-decontamination 

In addition to the pragmatic spirit of Vaisala 

sales, after-sales support created a sense of 

trust. “In 2020, one of our customers encountered 

a problem that required urgent support,” 

says Zhu Zhengcai. “Even though it was 

a weekend, Vaisala’s technicians serviced the 

sensors and delivered them to the application 

site on the same day. The problem was 

quickly resolved. Vaisala’s speed of response 

is second-to-none in industry.” 

With robust measurement solutions backed 

up by responsive support TKSAGE looks 

forward to future endeavors with Vaisala. 

Vaisala GmbH 

Rheinwerkallee 2 

D 53227 Bonn 

Telefon: +49 228 249710 Telefax: +49 228 2497111 

eMail: vertrieb@vaisala.com 

www.vaisala.de


NEWSLETTER 

www.cleanroom-online.com Edition EN 12-2022 | Page 12/42 

Standards are here to stay 

You may not always notice when standards are in place, but they are present everywhere. World Standards Day on 14 October marked the 

75th anniversary of the founding of the International Organization for Standardization (ISO). Switzerland has been a member of ISO since 

the beginning and still holds substantial weight within the organisation. 

Urs Fischer, CEO of the Swiss Association for Standardization (SNV), 

knows that Switzerland has a powerful voice when it comes to the 

standards process in international committees. This applies not only 

to traditional topics such as ski bindings, cable cars or mechanical engineering, 

but also in other areas such as leadership principles and 

management issues. Swiss experts have the option of participating 

in standards committees within many sectors. The SNV actively calls 

for collaboration in the relevant professional groups. The idea is for 

people with the pertinent experience to set and examine practicable 

standards and then to adapt them later as necessary. Leading the development 

and monitoring process is the task of the SNV. It serves as 

a hub for standards and provides a link to international committees. 

Standards are not laws 

In our buildings and in our infrastructure, as well as in nearly every product 

available, standards are being put into practice. But what do they 

do? Standards allow for more efficient production, administration and 

storage. They lead to better compatibility between technical devices 

and equipment. They also encourage trust on the part of consumers. 

When standards are applied, it means that basic requirements are 

being met in regard to health, safety and the environment. As standards 

are checked every five years and revised as necessary, they remain 

up to date. They accommodate new areas or topics, for example, 

changes based on digitalisation or the inclusion of climate change 

as a forward-looking measure. They incorporate hot topics such as 

blockchains or megacities. They integrate social developments such 

as demographic changes or sustainability issues. In general, standards 

are widely accepted as they originate from practice and are created 

for practice. In certain instances, laws also refer to standards; in these 

cases standards take on a legally binding character. In all other cases, 

observing standards is voluntary because they are created by private 

organisations. However, as these organisations work closely with government 

bodies, standardisation is a good example of a successful 

Public-Private Partnership (PPP), a cooperative undertaking between 

the public and private sector. 

What does SN EN ISO 9001:2015 mean? 

The number 9001 refers to the standard for quality management. The 

year after the colon refers to when the revised version of the standard 

was published. If the standard is revised again, this year is replaced 

by the new publication date. Each standard is numbered using this 

system. 

ISO stands for International Organization for Standardization. Over 

165 countries worldwide are currently represented in ISO. The organisation‘s 

head office is in Geneva. ISO standards are developed for the 

global market. Switzerland is a member of this organisation and can


NEWSLETTER 


participate in developing standards via the SNV. 

The abbreviation EN indicates that this is a standard that was developed 

for the European area. In the case of EN ISO 9001, it means 

that the international standard was adopted by CEN (European Committee 

for Standardization). 

The abbreviation SN means that a standard was developed for the 

Swiss market. Accordingly, SN EN ISO 9001 means that the international 

and European standard for quality management was also adopted 

into the Swiss body of standards. As Switzerland works on both European 

and international standardisation, usually the international or 

European standards are adopted and any contradictory national standards 

are withdrawn. In the foreword or appendix to the international 

standards, special national cases are mentioned or supplemented, but 

the actual content of the standard stays the same everywhere. 

The CE marking 

The CE marking is likely the most well-known label for consumers. It 

was created to identify products that conform to EU legislation. The 

CE marking is often described as a passport for the European single 

market. Manufacturers use it to show that they have incorporated all 

the special requirements of EU legislation into the product they are 

selling. As EU legislation refers to the relevant standards in the same 

way that Swiss legislation does, the CE marking also signifies that these 

standards are being observed. In Switzerland the CE marking is not 

mandatory, but as many Swiss products are also distributed to the EU 

market, it is widely seen on our products here. 

Schweizerische Normen-Vereinigung (SNV) 

CH 8404 Winterthur 

Clean Communication: 

SEMI Standards 

SEMI standards form the basis for digital communication in the microelectronics 

industry. There are various SEMI standards that facilitate 

the integration of storage and transport systems in automated factories, 

e.g. in semiconductor manufacturing. 

The SEMI E88 standard, for example, defines an interface for the 

connection of stocker systems. This standard specifies an operating 

model for cleanroom stockers as seen by a factory automation controller 

(customer host). The definition provides a standard host interface 

and information about the operational behaviour of the plant 

(e.g. control, state models and data reports). Topics such as handling 

queues as well as scheduling and transport of transfer units are also 

covered there. 

However, there are corresponding SEMI standards not only for storage 

systems, but also for transport units. For example, the SEMI E82 

and E153 standards define the communication basis for interbay and 

intrabay transport systems as well as for material handling equipment 

that supports transport, storage or a combination of transport and 

storage. 

For every storage and transport system from Schiller, there is the 

corresponding software for warehouse management and control, for 

controlling the conveyor technology and for data acquisition and evaluation. 

If required, this can be extended for customer-specific requirements, 

such as special processes, special features or further interfaces. 

Schiller‘s software solutions are standard-compliant and use the 

above-mentioned SEMI standards to enable easy integration in the 

factories. The special feature: Schiller has its own driver software that 

interprets and translates the commands - so no third-party tool is needed. 

This makes it possible to realise special customer requests and to 

react flexibly to requirements. 

Schiller Automatisierungstechnik GmbH 

Donau-Gewerbepark 30 

Telefon: +49 9932 9504 0 

Telefax: +49 99329504 900 

eMail: firma@schiller.de 

Internet: http://sci.schiller.de 

D 94486 Osterhofen


NEWSLETTER 


BioSensoLab 

- Biological laboratory to go 

The laboratory offers space for up to seven fully functional 

work-stations. © Fraunhofer IBMT, Markus Michel 

Researchers from the Fraunhofer Institute for Biomedical Engineering IBMT have developed the “BioSensoLab“, a mobile biological 

laboratory with which they can demonstrate new developments to customers and test them together – on site at their companies. These 

new technologies rely in particular on intelligent sensors combined with artificial intelligence to perform analyses. 

“Never change a running system” – this is especially true for companies. 

Before adopting new methods into their ongoing production 

and thus risking production lines coming to a standstill, the processes 

must be tried and tested extensively. And ideally that should happen 

on site. However, the conditions are not always suitable for this. Proximity 

to the site takes on additional importance when it comes to 

artificial intelligence (AI) in combination with sensitive data. After all, 

the AI must first be trained with appropriate data in order to be able to 

assess sensor data that is recorded later and make decisions based on 

this. To do this, the data is often moved to the cloud via the internet. 

However, companies prefer to keep sensitive data in-house. 

BioSensoLab mobile work platform 

Researchers from Fraunhofer IBMT have developed a solution for this. 

“With our BioSensoLab mobile work platform, we can demonstrate 

new technologies, for example in the field of stem cell production, 

directly at the customer’s site and apply them together,” explains Dr. 

Thomas Velten, working group leader at Fraunhofer IBMT. “In addition, 

sensitive data does not need to leave the organization – the lab can 

be set up in a factory hall on the company’s premises, for example.” 

This is because, with a length of 7.8 meters, a width of 2.5 meters and 

a height of 3 meters, it offers sufficient space for biological and other 

investigations but does not take up too much room. The lab is designed 

as an BSL-2 laboratory and can therefore be used for biological 

investigations. Biosafety level 2 includes working with microorganisms 

that pose a potential hazard to laboratory staff and the environment. 

Examples of such agents are salmonella, herpes pathogens or flu viruses. 

BSL-2 laboratories usually have access control and are equipped 

with facilities to contain infection gases and liquids. 

The digital infrastructure of the “BioSensoLab“ is also designed in 

such a way that it can be integrated into existing electronic data processing 

systems (EDP) and production facilities. The modular interior 

equipment can be flexibly adapted to requirements; it can be moved 

and is easy to install or remove. To change its location, the lab can be 

transported using an integrated lifting device and a truck. 

Developing the mobile BSL-2 lab required the pooling of various 

areas of expertise: An industrial partner from the special-purpose vehicle 

sector contributed its know-how in the construction of transportable 

units, while the researchers at Fraunhofer IBMT contributed 

their expertise in biological laboratories. “Over the years, we have also 

acquired the expertise to build mobile labs, so we were able to design 

it and coordinate its construction,” says Velten. “So on the one hand, 

we know how a laboratory has to be equipped, for example in terms 

of heating, ventilation, and air conditioning (HVAC) technology but, 

on the other hand, we also know what equipment the vehicle manufacturer 

can install.” 

Intelligent sensors from the Fraunhofer Center for Sensor 

Intelligence ZSI improve the quality of the product 

When building the mobile laboratory, the Fraunhofer IBMT researchers 

already had specific applications in mind, namely the technologies 

that they are currently developing at the new Fraunhofer Center for 

Sensor Intelligence ZSI in collaboration with the Fraunhofer Institute 

for Nondestructive Testing IZFP. The linchpin of this: Intelligent sensors


NEWSLETTER 


Mobile laboratory unit with integrated lifting device for a standard truck 

chassis. © Fraunhofer IBMT, Markus Michel 

Two modular class II safety workbenches for BSL-2 work. 

© Fraunhofer IBMT, Markus Michel 

are collecting increasingly more data that has to be condensed into 

meaningful information – which is almost impossible for humans to 

handle. Artificial Intelligence can score some points here: It analyzes 

the deluge of data and makes decisions based on the results, almost 

in real time. These decisions not only minimize wear and waste but 

also improve the quality of the products produced. “Our goal is sensor-intelligence 

devices, intelligent sensors whose data is analyzed by 

artificial intelligence to make more targeted decisions,” says Velten. 

One example of such an intelligent sensor system, which researchers 

are currently developing, falls within the area of stem cell production. 

“We don’t just want to check parameters such as temperature 

and pH value – and potentially end up having to throw away an entire 

batch as we have in the past – but instead we want to characterize 

and monitor the stem cells themselves by means of intelligent sensors. 

And, if possible, without having to remove them from the bioreactor,” 

explains Velten. The research team is currently working out 

exactly how this can be achieved. The mobile laboratory offers the 

ideal conditions for involving industrial enterprises in the development 

process and for conducting joint research on site, as well as 

for demonstrating the developments to interested parties. Another 

example of such developments are beating heart cells, which are already 

being grown at Fraunhofer IBMT and used in test systems. In 

the future, the researchers plan to grow these cells as 3D models in 

multi-well plates, containing, for example, 96 small wells side by side. 

Parallelized and automated toxicological studies will be performed in 

these multiwell plates: How does a heartbeat change when you add 

certain substances, such as compounds? This and other technologies 

can be developed, demonstrated and deployed with industry partners 

in the mobile laboratory. 

Fraunhofer-Institut für Biomedizinische Technik IBMT 

D 66280 Sulzbach 

Oxygen approval for 

GEMÜ butterfly valves 

A special version of the GEMÜ R480 Victoria butterfly valve 

series from Ingelfingen-based valve specialist GEMÜ is 

approved with immediate effect for the medium of oxygen. 

In the design for the medium of oxygen, all media wetted seal materials and auxiliary materials 

(lubricants and screw locking agents) from the Victoria butterfly valve series have been tested and 

approved by the Federal Institute for Materials Research and Testing (BAM). Unsuitable oils and 

greases can lead to the development of fires, which is why all media wetted components must be 

cleaned accordingly. 

The examination for BAM approval was based on the DIN EN 1797 and ISO 21010 standard. 

Approval is limited to the use of gaseous oxygen at a maximum operating temperature of 60 °C and 

a pressure of 15 bar. The butterfly valves of the GEMÜ R480 Victoria series approved for oxygen applications 

are recognizable by the special function O. The approval refers to EPDM seal material code E 

and stainless steel disc material code A. 

GEMÜ Gebr. Müller Apparatebau GmbH & Co. KG 

D 74653 Ingelfingen


NEWSLETTER 


Optimising wind energy sustainably 

weisstechnik supplies high-performance climate simulation systems for load tests 

on wind turbine electronics 

Wind power makes an important contribution to combating climate change. However, breakdowns as well as maintenance and repair 

of wind turbines are usually time-consuming and costly. This often affects the power electronics, which are exposed to extremely high 

loads. This is why the University of Bremen is researching how to extend their service life and optimise maintenance as part of the joint 

project HiPE-WiND, funded by the BMWi. As part of this project, weisstechnik has planned and implemented a climatic test chamber for 

multidimensional load tests. 

Partner for wind energy research 

The joint project HiPE-WiND (High Power Electronics in Wind Energy 

Plants) is being led by the Institute for Electrical Drives, Power Electronics 

and Devices at the University of Bremen in cooperation with the 

Fraunhofer Institute for Wind Energy Systems in Bremerhaven. In order 

to find out which components of the power electronics fail under 

which conditions, long-term load tests are carried out on complete 

wind turbine converter systems up to the ten megawatt class. This 

simulates the high loads caused by changing wind conditions and 

the power grid under different climatic conditions - from the Arctic to 

the Sahara. All this is taking place in the customised climate chamber 

developed by weisstechnik. As the climatological heart of the „HiPE- 

LAB“ in Bremen, the climate chmber helps to realistically and quickly 

recreate how the converter systems age under the multimodal loads 

during 20 years of use. 

300 kW large-scale facility with heavy duty floor 

As an experienced specialist in environmental technology, weisstechnik 

was able to successfully win the tender for the facility and 

plan and realise the project from a single source. The size and performance 

of the walk-in and drive-in chamber was a demanding task 

in itself, needing a usable test space volume of approx. 190 m3 and 

an electrical connected load of just under 300 kW. The surface load 

of the heavy-duty floor in the test space is more than 10,000 N/m2. 

The large test specimens - switch cabinets with converters - weighing 

up to 5,000 kg are moved into the test chamber on rollers via 

a double-wing door. The inner chamber walls are made of stainless 

steel (welded vapour-tight) and have a 200 mm thick 2-layer insulation 

consisting of special foam and mineral wool. A side door serves 

as access for the staff. 

Environmentally friendly CO2 refrigeration system 

The required temperature range for the tests is (-)40 °C to (+)120 °C. In 

order to realise this as efficiently and environmentally friendly as possible, 

a CO2 cascade refrigeration system was used. This means that 

temperatures down to (-)45 °C can be achieved with ease while at 

the same time enabling a high level of thermal compensation. This is 

important for the load tests because the test specimens tested under 

load generate a high thermal load. This is around 70 kW at 100 °C and 

a humidity range of up to 95% RH and 50 kW at 85 °C/85% RH. The 

use of CO2 as a refrigerant necessitates additional safety devices. It 

was therefore necessary to integrate a standstill cooling system with 

a separate power supply in order to prevent the CO2 from expanding 

and to avoid excessive system pressure during system standstill. In addition, 

a gas warning system is integrated in the test chamber and 

in the equipment compartment, which triggers visual and acoustic 

alarms and activates the emergency purge if CO2 escapes. Furthermore, 

the oxygen content is continuously monitored with redundant 

measuring technology. 

(Source: Weiss Technik GmbH)


NEWSLETTER 


Customised technology 

Vertical air guidance was chosen to achieve a particularly homogeneous 

climate distribution within the test space. The pre-tempered 

air is fed into the test space from below via a heavy-duty double floor 

made of stainless steel perforated sheet metal (in which the connection 

lines for the test objects can also be laid), it is then fed through 

the heat exchanger and upwards. Under the ceiling, the air is laterally 

discharged and fed back into the air treatment room. The recirculation 

fans can be continuously adjusted and the humidity is realised 

hygienically via steam humidification. The equipment compartment 

next to the test chamber contains all the necessary aggregates and 

control cabinets. It was an important requirement that the sound level 

of the system must be below 72 dBA. The units were fitted with special 

sound insulation to ensure that this could be achieved reliably. 

The system is controlled simply and intuitively via the tried and 

tested SiMPAC® controller, which has been optimised for environmental 

simulation systems and is the digital measurement and control system 

for operation, monitoring and documentation. The system can 

be operated via a touch panel (with the innovative WEBSeason® user 

interface) on the outside of the equipment compartment. In addition, 

the system can be operated in the convenient remote mode via an 

EtherCAT interface and network interface. 

Environmental simulation technology for climate change 

The multimodal test facility has been operating successfully in the 

HiPE WiND research project in Bremen since mid-2021. The resulting 

combination of realistic climatic and electrical load tests is perfect for 

determining how wind turbines can be made more robust and durable. 

Weisstechnik has therefore made another important contribution 

to the energy revolution. 

Weiss Klimatechnik GmbH 

Geräte- und Anlagenbau 

Greizer Str. 41-49 

D 35447 Reiskirchen 

Telefon: +49 6408 84 6539 

Telefax: +49 6408 84 8722 

eMail: info@weiss-technik.com 

Internet: http://www.weiss-technik.com 

Investing 100 million euros in the 

construction of a new US production plant 

“We are investing 100 million euros in a completely new production 

plant in the USA”, says Joachim Ley, Chief Operating Officer of 

the fan manufacturer Ziehl-Abegg. This is the largest single investment 

at one location in the company‘s 112-year history and is the 

result of the strong growth in quiet, robust and energy-saving fans 

in the markets in Mexico, Canada and the USA. 

Growth in North America has enabled the Greensboro (North Carolina) 

site to increasingly accelerate its rate of expansion since its inception 

in 2004. The figures are impressive: In the first 10 years, the number 

of employees at Ziehl-Abegg in the USA only grew from 0 to 40; in 

the past 8 years it has already increased from 40 to 230. And by 2030, 

it is anticipated that there will be 800 people working for Ziehl-Abegg 

in the USA. The headquarters of Ziehl-Abegg USA is responsible for 

the whole of North America and has eleven sales offices serving the 

markets in the USA, Mexico and Canada. 

Ziehl-Abegg is a world leader in the field of ventilation and drive 

technology, in combination with the corresponding control technology. 

„In addition to data centres, areas of application for the products 

include heating and refrigeration systems, clean rooms and agricultural 

systems,” says Mirco Herrmann, the US Managing Director of Ziehl- 

Abegg. 

The new plant, with administration building attached, will be 

constructed in Winston-Salem (North Carolina). This is about 20 kilometres 

away from the existing site. The building, covering an area of 

46,500 square metres, is expected to be ready for occupancy in 2024. 

The existing production plant will then be relocated to the new site 

in 2025. 

Ziehl-Abegg will be making the largest single investment in the 

company‘s history in order to expand production and sales in the USA. 

(Photo: Ziehl-Abegg) 

The production plant will have a high level of vertical integration. 

Chief Operating Officer Ley: “We will not only be expanding capacities 

but also increasing the level of vertical integration. Thanks to a fully 

system of self-contained system of production, starting with the motors, 

we will be able to offer our customers a high degree of flexibility 

and short delivery times.” Winding machines, welding robots and CNC 

machines haven been installed for this purpose. Due to the location’s 

central function, the site will include a high-bay warehouse.“ And in 

the medium term, we will also be setting up a development hub with 

a laboratory in Winston-Salem,” says Mirco Herrmann. This will require 

an extensive system of air measurement and motor test rigs. 

Ziehl-Abegg SE 

D 74653 Künzelsau


NEWSLETTER 


New development for lab automation 

APD tool from Syntegon identifies optimal process parameters for tablet presses 

– Automated test runs thanks to innovative powder feeding system 

– Realistic simulation of subsequent production conditions 

– Optimal process parameters determined on an exact data basis 

After the successful launch of the Automated 

Process Development (APD) tool for capsule 

filling processes in 2020, Syntegon is now 

expanding this expertise for tablet presses. 

The new, automatically adjustable powder 

feeder and the APD software offer pharmaceutical 

manufacturers a complete package 

to determine the ideal process parameters 

for each product and easily transfer them to 

production machines. “While manual analyses 

used to take days or even weeks, the APD 

tool achieves faster and more precise results 

with much less product,” says Matthias Moessinger, 

Senior Market Expert Pharma Solid at 

Syntegon. 

Simulating exact process parameters 

“Tablets have a significantly higher number 

of relevant parameters and quality attributes 

compared to capsules – from shape or diameter 

to thickness and hardness, numerous 

properties play an important role,” Moessinger 

explains. “In the first step, we focused on 

powder feeding and the various feeder designs; 

others will follow.” The new powder feeding 

system is specifically tailored to the TPR 

200 tablet press from Syntegon. The system 

can be adjusted automatically to fit every 

possible stirrer configuration. The impellers 

have a square and a round side to reflect factors 

such as the influence of powder movement 

on tablet properties. In addition, the 

speed and direction of rotation as well as the 

inclination of the stirrer blades can be varied. 

Faster time to market with laboratory 

automation 

With the new, automatically adjustable 

powder feeder and APD software pharmaceutical 

manufacturers can determine the ideal 

process parameters for each product. 

During the product tests, the APD software 

evaluates and optimizes the process parameters 

regarding their influence on critical 

quality attributes. As a major highlight, both 

the changeover of the feeding system and 

the tests are fully automated; human intervention 

is no longer necessary. The APD tool 

is based on Design of Experiments (DoE) 

and analyzes the functional relations between 

material properties, process parameters 

and critical quality characteristics of the 

final product. This enables pharmaceutical 

manufacturers to accurately simulate the 

production situation and determine reliable 

parameters thanks to a clearly defined data 

basis. They save time, reduce product loss, 

increase product quality, and facilitate process 

validation. 

Process optimization at the 

OSD Customer Center 

The APD tool is suited for tests in the development 

phase as well as for optimizing existing 

processes. Together with customers, Syntegon 

tests both active ingredients and placebo 

formulations at the OSD Customer Center 

in Waiblingen with the automated feeding 

The compact TPR 200 Plus tablet press supports 

the efficient production of small and mediumsized 

batches, using an integrated Data 

Acquisition System (DAQ) to assess tablet quality 

and process stability. 

system. “Our experts know the challenges 

and can support pharmaceutical manufacturers 

in determining the optimum process 

parameters based on decades of experience,” 

says Moessinger. “We have been technology 

leader in capsule processing for many years. 

Now our APD tool and automated powder 

feeding system also offer customers a structured 

and particularly efficient solution for 

process optimizations in tablet pressing. Further 

innovations will follow.“ 

Syntegon Technology GmbH 

Blaufelder Straße 45 

D 74654 Crailsheim 

Telefon: +49 7951 4020 

eMail: packaging-ph@syntegon.com 

Internet: http://www.syntegon.com


NEWSLETTER 


About Perseverance 

and Winning 

Cleanzone Award 2022 for „Reinraum-Mieten“ 

Wolfgang Hassa can tell you a thing or two about defeats, setbacks 

and failures. Like many imaginative, optimistic and innovative entrepreneurs. 

But while many give up in frustration, the head and owner 

of Reinraum-Mieten has learned one thing above all in the course of 

his thrilling professional career: Only those who persevere can reach 

their goal. Now, after years of striving for recognition in the dynamic 

cleanroom market, Wolfgang Hassa has won the Cleanzone Award 

2022. 

As Victor Hugo once said, „Nothing is stronger than an idea whose 

time has come.“ Wolfgang Hassa knew from the start that the idea 

was a great one. But the market was not yet ready for mobile, textile, 

freely configurable and, above all, rentable cleanrooms. And so the 

first presentation of the concept at Cleanzone fair, at that time still as 

a purchase variant, was almost smiled at a little in 2018. Cleanrooms, 

that had to be something solid, firm, reliable, stable and above all durable. 

After all, a cleanroom is about something: cleanliness and safety, 

which, according to the majority‘s pre-judgment at the time, can by 

no means be guaranteed in a „tent“. 

So, with articles in the press, visits to customers, countless conversations, 

presentations and videos, patient educational work had to be 

done to advance the idea. Gradually, the realization filtered through 

that individually configurable cleanrooms with a flexible period of use 

under full cost control offer considerable economic and organizational 

advantages. Not to mention the flexibility and functional convertibility. 

On the occasion of Cleanzone 2022 in Frankfurt, Wolfgang Hassa presented 

his transformed concept coherently and demonstrated it in 

situ - and convinced both the jury and the audience. The Cleanzone 

Award 2022 went to ... Reinraum-Mieten. Of the eleven applications 

submitted for this innovation award, five had made it through to nomination 

and were presented to a broad audience on the two days of 

the trade show, the majority of whom, like the expert jury, opted for 

the concept of temporary, rentable cleanrooms. 

REINRAUM-MIETEN 

by Wolfgang Hassa 

Rottstr. 33 

Telefon: 0177 8890417 

eMail: hassa@reinraum-mieten.de 

D 52068 Aachen 

Internet: http://Reinraum-Mieten.de


NEWSLETTER 


Cellefill, a new integrated 

solution to fast-track cell, 

gene and biological therapies 

Aseptic fill/finish experts Flexicon Liquid Filling, part of Watson-Marlow 

Fluid Technology Solutions (WMFTS), and barrier technology specialists 

Franz Ziel GmbH, today announce the launch of Cellefill- a 

turnkey, vial fill/finish system with an integrated barrier solution. 

Enhancing good manufacturing practice (GMP), customer compliance 

and efficient aseptic manufacturing is essential as new advanced 

therapy medicinal products (ATMPs), including cell, gene and biological 

products advance through clinical trials to commercialisation. 

To meet these new requirements, Cellefill integrates the features 

of Flexicon’s FPC60 aseptic vial filling machine with barrier technologies 

from Franz Ziel. Cellefill’s process design includes use of asepticsu 

single-use-systems (SUS) and pre-sterilised ready to use (RTU) 

product containers that enter the Grade A filling zone by a No Touch 

Transfer (NTT) debagging system. Cellefill is a GMP compliant solution 

that delivers enhanced levels of process flexibility to accelerate production 

of ATMPs and biological therapies. 

The emerging role of personalised medicine in ATMPs and biological 

therapies has led to a shift in how manufacturers approach batch 

production methods. Biopharmaceutical companies are increasingly 

looking for ways to manufacture the smaller batches needed for patient-specific 

medicines, in a way that is cost-effective to produce and 

validate. 

Meeting these customer needs, Cellefill maximises production 

efficiency with features including recipe driven, remote set-up, zero 

waste start-up and no format parts for the entire vial range. 

Steve Adams, Product Manager for Cellefill at WMFTS, says: 

“Through process flexibility, Cellefill enables the scale out and process 

repeatability our customers need to assure product quality at all levels 

of manufacturing. Providing expert guidance and support through a 

single point of contact, we are a committed project partner to biopharmaceutical 

companies at the cutting-edge of personalised medicine. 

„The challenge for the industry is to produce these new therapies 

quickly, safely and cost efficiently, with a system that can be rapidly 

changed over between batch or different small batch medicines.” 

Designed to suit various filling requirements and class cleanrooms, 

the Cellefill solution is available in three models with different 

barrier technologies. Each model delivers enhanced levels of process 

and quality assurance with highly accurate peristaltic pump performance, 

integrated barrier and environmental monitoring. 

Cellefill builds on the partners’ experience in providing technology 

and extensive support through validation, qualification and operator 

training to facilitate a smooth transition into GMP compliant and 

cost-effective manufacturing. 

Markus Horsch, division manager sales and marketing from Franz 

Ziel says: “Cellefill is a fully integrated vial fill/finish and barrier technology 

solution supporting enhanced levels of product quality and 

sterility assurance to mitigate risks of contamination. Cellefill adopts 

pre-designed and configurable modules to reduce project time and 

fast track therapies to market. 

„Cellefill minimises batch changeover time with enhanced cleanability, 

rapid Vapour-phase Hydrogen Peroxide (VHP) cycle times and 

gloveless operation in the aseptic core, while retaining the possibility 

of risk-based compliant interventions if needed in rare incidences to 

prevent batch loss.” 

The Cellefill solution enables a streamlined project timeline with 

integrated technical and GMP documentation to increase efficiency 

of the project validation and qualification stages. 

The modularity, flexibility, scale out capabilities and efficiencies 

establish Cellefill as a next generation vial fill/finish solution for new 

ATMP and biologic products as they advance through clinical trials to 

commercialisation. 

Watson-Marlow GmbH 

D 41569 Rommerskirchen


NEWSLETTER 


Partners against grime 

Lercher Werkzeugbau: Family business from Austria produces 

dental technology components 

Not precise but super-precise; not hygienic but ultra-hygienic. When it comes to products for medical technology, precision and technical 

excellence are crucial. This is something that Lercher Werkzeugbau GmbH & Kunststoffspritzguss from Klaus in Vorarlberg, Austria, knows 

only too well. The company is currently moving into medical technology with its own clean room production. And ARBURG is an essential 

partner here. 

The company produces plastic dental parts with a machine that is directly 

connected to a clean room. These are then combined to form 

an assembly. The hybrid ALLROUNDER 520 H with clean room equipment 

transports the encapsulated items to another, larger clean room 

where part inspection and packaging take place. At the end of this 

clean room, the goods are packed ready for delivery. The products are 

made of PBT and PE. A total of four machines are planned for the final 

expansion of the system. “ARBURG has a great deal of experience 

and knowledge in all areas, and especially in automation and medical 

technology. We notice this again and again,” says Sandra Ender-Lercher, 

Managing Director of the family business, praising the cooperation 

and support in general. 

Hybrid ALLROUNDER first choice 

After the first hybrid ALLROUNDERs were purchased and subsequently 

the first successful turnkey project with an ALLROUNDER 520 H, the cooperation 

continued with the clean room project. For the automated 

production of the dental components – three different items in multiple 

moulds – the hybrid ALLROUNDER HIDRIVE series was also the 

obvious choice, as it combines the speed of the servo-electric toggle 

with a dynamic, hydraulic injection unit for maximum precision and 

performance. As Sandra Ender-Lercher says: “The catalogue of requirements 

for these plastic dental parts calls for precision so that there are 

no problems for the end customer with regard to quality or sterile packaging, 

for example.” Due to this machine characteristic, larger multicavity 

moulds can also be used in combination with smaller machine 

sizes. Ultimately, this is also a question of costs. Series production started 

in the first half of 2022. Two clean rooms work in combination to 

produce the dental technology components. The machine, which is 

docked directly to the Class 8 clean room, is equipped with a KUKA sixaxis 

robot equipped with the SELOGICA user interface on its control 

system. This robot removes the moulded parts which are transported 

to the second clean room via a conveyor belt. Two clean-air modules 

with main and pre-filters are fitted above the ALLROUNDER clamping 

unit and the robotic system housing. Lercher builds its own moulds. 

Robot systems with removal hands and grippers were independently 

commissioned directly on site. All machines are equipped with a host 

computer connection via OPC-UA as well as reject switches to ensure 

accurate tracking and quality of the manufactured parts. 

More than just a partnership 

“We have been exchanging information with ARBURG on clean room 

technology since 2019. And since we have now also successfully introduced 

the medical standard after IATF 16949, there was nothing 

standing in the way of the clean room facility,” comments Sandra Ender-Lercher. 

ARBURG’s pre-sales and after-sales service is particularly 

impressive. As Sandra Ender-Lercher says: “We are taken seriously as a 

customer. The right contact persons are always there for us, and so we 

always get to a practical solution quickly.” 

ARBURG GmbH + Co KG 

D 72290 Loßburg 

The ALLROUNDER is docked to a clean room in which 

moulded parts are tested and assembled. 

(Photo: PATRICK SAELY PHOTOGRAPHY) 

Two clean rooms are combined in the turnkey system, and parts handling 

is performed by a six-axis robot integrated into the machine controller. 

(Photo: PATRICK SAELY PHOTOGRAPHY)


NEWSLETTER 


Emöke Sogenbits appointed Chairwoman 

of the Board of Raumedic Estonia AS 

On October 17, Emöke Sogenbits was appointed Chairwoman of the Board of Raumedic Estonia AS, a subsidiary 

of the German Raumedic Group. 

Raumedic Estonia AS clean room in Tallinn, Estonia. 

Ms. Sogenbits served in numerous positions 

of leadership in operations over the course 

of her long international career, including 

as President Cluster Baltics at the HANZA 

Group. In 2019 she was decorated as “Woman 

of the Year” in Estonia for her contributions 

to society. 

Ms. Sogenbits is looking forward to her new 

challenge at Raumedic: “I’m excited to bring 

my decades-long experience and expertise 

in operations to a growing international business 

in the field of medical technology. The 

Raumedic site in Tallinn is currently being 

significantly expanded to meet the increa- 

sing demand for our products. Guiding this 

growth is a challenging task that requires a 

clear strategy and decisive leadership. That’s 

what I will fully focus on.” 

Raumedic Estonia AS specializes in the 

assembly of medical technology products 

and is equipped with corresponding cleanroom 

production space, which is currently 

being expanded to approximately 1.000 

square meters by the end of 2023. 

Stefan Seuferling, CEO of the German 

Raumedic AG, and Chairman of Supervisory 

Board of Raumedic Estonia AS, is optimistic 

about the future of the Estonian site, not least 

due to recent developments: “Growth always 

requires a leader with a clear strategic vision. 

Emöke Sogenbits has proven her excellence 

in operations and leadership over the course 

of her impressive career. I’m really looking forward 

to working with her. With the expansion 

of our assembly capacities and a new and internationally 

experienced operations expert 

with an impressive regional network at the 

head of our site in Tallinn, we are well equipped 

for the future of Raumedic in Estonia.” 

Emöke Sogenbits, newly appointed Chairwoman of the Board of Raumedic Estonia AS. 

(Picture: Andras Kralla) 

Raumedic AG 

D 95233 Helmbrechts


NEWSLETTER 


New fully automated warehouse 

expands storage and boosts 

logistical infrastructure 

Additional investments across the company support customer supply needs 

With a total investment of approx. 20 million 

euros, the new fully automated building provides 

storage space for materials with highstock 

turnover rates such as packaging components 

and thus optimizing our logistical 

infrastructure. In addition, valuable capacity 

will be freed up in the existing warehouse. 

Construction of the warehouse began in 

April 2021 and was designed to further address 

our strategic expansion plans. “We have 

already taken a process-related expansion 

concept into account during our planning 

process. The warehouse operation will initially 

start with a two-shift operation which can 

be extended to three shifts per day,” explains 

Peter Mayer, Senior Vice President Customer 

Project Management, Procurement and Logistics. 

The new storage facility includes 7,700 

sq. meters of logistics space consisting of 

1,200 sq. meters for incoming and outgoing 

goods and 6,500 sq. meters of room temperature 

storage with the capacity for more 

than 16,000 pallets and a shelf height of 14 

meters. The state-of-the-art high-bay warehouse 

is equipped with automated forklifts 

and six positions for trucks on a receiving 

area ramp connected to the transfer area. 

Four driverless shuttles connect the transfer 

area with the building’s shelves while four 

driverless forklifts operate between them. 

“The additional warehouse is a further testament 

of our commitment to support our 

customer’s supply chain needs,” states Managing 

Director Peter Soelkner. “We have 

also planned for more investment projects 

that will help us to continue the momentum 

of sustainable growth of our company.” The 

numerous investments at all our sites include 

the recently completed extension of the 

development service laboratories as well as 

a new multipurpose building at the Ravensburg 

South production site that houses laboratories 

for quality control, thawing rooms, 

offices and a new attractive employee can- 

teen. The completion of another production 

building for aseptic manufacturing, at the 

CDMO’s Schuetzenstrasse site, is planned 

for the end of 2026, with several new cleanrooms 

to be realized in the subsequent years. 

In addition, the implementation of further 

automated visual inspection machines is 

planned. Managing Director Thomas Otto 

summarizes: “Despite the multi-faceted challenges 

we currently face, such as pandemic 

as well as political and economic circumstances, 

we will continue to invest over the next 

years to expand our capacities in the areas 

of development services, aseptic filling, visual 

inspection and packaging to meet the 

increasing market demand. The planned expansions 

will go hand in hand with the optimization 

of the infrastructure across all our 

sites.” 

Vetter Pharma International GmbH 

D 88212 Ravensburg 

Neues, vollautomatisches Lager für Verpackungsmaterialien. © Vetter Pharma International GmbH


NEWSLETTER 


Röchling Medical opens new production 

hall and creates 30 new jobs 

– Building forms part of an investment program with a volume of EUR 50 million until 2025 

– Expansion enables production of up to 100 million tanks a year 

ry because Röchling Medical has acquired 

a major order from a high-profile German 

pharmaceutical company for around 30 million 

tanks a year and this would have exceeded 

its existing capacity. The plastics processing 

company now aims to obtain additional 

major orders for the Neuhaus site, which 

produces packaging systems for the pharmaceutical, 

diagnostics and medical technology 

industries. Manufacturing, assembly, 

and packaging take place under controlled 

conditions in clean rooms. 

The new building has a total area of 1,850 

square meters. The first floor of the four-story 

building is home to the central element: 

a GMP class C and D clean room production 

facility covering a total of 1,700 square meters, 

where containers, bottles, and canisters 

made from thermoplastic materials will be 

produced for pharmaceutical and diagnostic 

applications from the first quarter of 2023 onward. 

Röchling has also invested in co-extrusion 

blow molding machines for the produc- 

Opening the new production hall of Röchling Medical Solutions SE in Neuhaus am Rennweg together 

on Friday (from left): Jürgen Köpper, First Deputy Mayor of the Sonneberg district; Uwe Scheler, 

Mayor of Neuhaus am Rennweg; Dr. Daniel Bühler, CEO Röchling Medical; Alexander Stauch, Site 

Manager Röchling Medical Neuhaus; architect Michael Müller; Thuringia‘s Minister of Economy 

Wolfgang Tiefensee; Evelyn Thome, CFO Röchling Group; Raphael Wolfram, Spokesman of the Executive 

Board Röchling Group; Dr. Carl Peter Thürmel, Member of the Advisory Board Röchling Group; 

and Dr. Andreas Gabriel, COO Röchling Medical. (Photo: Röchling) 

Röchling Medical Solutions SE, a subsidiary 

of the Mannheim-based Röchling Group, 

celebrated the opening of the new production 

hall at its Neuhaus am Rennweg site 

in Germany on Friday, September 30, 2022. 

A total of EUR 50 million will be invested in 

the expansion until 2025, making it one of 

the Röchling Group’s biggest investments 

in a single location. The globally active plastics 

processing company will soon be able 

to produce up to 100 million tanks a year at 

this site using the co-extrusion blow molding 

technique. 

“I am delighted that we have been able 

to expand our production capacities in Neuhaus 

with the new building. This lays the 

foundation for further organic growth and 

will allow us to meet our customers’ needs 

and requirements even more effectively in 

the future,” comments Dr. Daniel Bühler, who 

became the new CEO of Röchling Medical in 

early July. The investment, which is also creating 

30 new modern jobs, became necessation 

facility. This will give the company a total 

annual capacity of between 80 and 100 million 

tanks, depending on the size required. It 

will be able to produce tanks with a volume 

of between two milliliters and ten liters. The 

material preparation facility and the ventilation 

and filtration systems are based on the second 

floor above the clean room. The ground 

floor is home to the plant room and logistics, 

some of which satisfy clean room conditions. 

The Neuhaus site has expertise in almost 

all single-layer and multilayer blow molding 

technologies. “In particular, we have many 

years of experience and well-established 

expertise when it comes to extrusion blow 

molding. Combining this with automation 

and inline process controls allows us to manufacture 

and deliver highly complex products,” 

says site manager Alexander Stauch. 

To meet the specific demands of the medical 

technology and pharmaceutical industries, 

the planning process was conducted with a 

particular view to ensuring compliance with 

regulatory requirements and enabling automation. 

The overall internal product flow is 

managed by an autonomous transport system 

to optimize production workflows under 

clean room conditions and to avoid product 

contamination. 

In addition to the location’s environmental 

and energy standards, which are already 

certified under ISO 14001 and 50001, the 

basement of the new building features a cold 

storage system to sustainably save energy resources 

and reduce carbon emissions. Under 

this concept, the firefighting water tank for 

the sprinkler system, which has a volume of 

around 2,000 cubic meters, is reduced to a 

low temperature overnight as cold storage 

and the energy produced is used to supply 

the production lines with cooling water during 

the day. “In addition to LED lighting and 

controlled room ventilation, we have installed 

a compressed air station so that we can 

generate process air using energy-efficient 

oil-free compressors that meet the highest 

cleanliness standards,” says Stauch, who is


NEWSLETTER 


responsible for the construction of the production 

hall. 

The plant was founded exactly 20 years 

ago as HPT Hochwertige Pharmatechnik. 

The Röchling Group, which is celebrating 

its 200th anniversary this year, acquired it in 

2015. Röchling has already invested EUR 35 

million in the first major phase of the location’s 

expansion. The plant site now encompasses 

more than 88,900 square meters, including 

six clean rooms with a total area of 

5,600 square meters, a logistics and a training 

center. Last year, Röchling Medical processed 

around 8,000 metric tons of plastic granulate, 

mostly polyethylene and polypropylene, 

to manufacture around 360 million items of 

primary packaging material in Neuhaus. The 

company currently has 380 employees. It generated 

annual sales of almost EUR 60 million 

in 2021. 

The new production building does not 

mark the end of the investments in the Neuhaus 

site. An existing building is being converted 

for another project, while a property 

acquired in 2019 in immediate proximity to 

the existing plant site is being transformed 

into an administrative and development 

building. 

Röchling Medical generated sales of almost 

EUR 190 million last year. Following a 

robust start to 2022, the division remains on 

track for further growth. In addition to Neuhaus, 

Röchling Medical operates sites in 

Brensbach and Waldachtal, both Germany, 

Lancaster, Pennsylvania/USA, and Rochester, 

New York/USA, and Suzhou, China. The Medical 

Division had more than 1,200 employees 

at the end of last year. 

Röchling SE & Co. KG 

D 68165 Mannheim 

Pfeiffer Vacuum Components & Solutions 

celebrates 25th anniversary 

ponents in Europe. The portfolio includes 

standard vacuum chambers as well as customized 

vacuum chambers and solutions with 

wide-ranging functions, which are manufac- 

Core competency in the field of welding. 

This year, Pfeiffer Vacuum Components & 

Solutions GmbH in Göttingen is celebrating 

its 25th anniversary. The company has one of 

the largest storage facilities for vacuum comtured 

using the latest technologies. On a site 

totaling 12,660 square meters, a workforce of 

around 140 people contributes to the success 

of the company. 

In the words of Guido Hamacher, Managing 

Director of Pfeiffer Vacuum Components 

& Solutions: “We are proud that our 

company has developed steadily over recent 

years and has invested in new technologies. 

In the past two years, in particular, we were 

able to attract many sizable projects from 

customers in Germany and internationally. 

Our products are used in a range of exciting 

applications. These include semiconductor 

chip manufacture, space simulation systems, 

energy storage, hydrogen tanks and forensic 

systems for detecting fingerprints.” 

Pfeiffer Vacuum Components & Solutions 

is a wholly owned subsidiary of Pfeiffer 

Vacuum Technology AG, a company which 

stands for innovative vacuum technology, 

high quality standards and outstanding customer 

service. Pfeiffer Vacuum employs over 

3,500 people worldwide and has 10 production 

sites and more than 20 sales and service 

companies. Pfeiffer Vacuum Components & 

Solutions GmbH was founded in 1997 under 

the name Trinos Vacuum-Systeme GmbH as 

a trading company for vacuum components. 

In 2010, Trinos Vakuum-Systeme was acquired 

by the Pfeiffer Vacuum Group and fully 

integrated into the Group. In 2017, the company 

was renamed Pfeiffer Vacuum Components 

& Solutions GmbH. 

Pfeiffer Vacuum Components & Solutions GmbH in Göttingen. 

Pfeiffer Vacuum GmbH 

D 35614 Asslar


NEWSLETTER 


Bronze medal awarded 

for sustainability achievements 

Software platform EcoVadis evaluates labour and human rights, environment, 

sustainable procurement, carbon management and ethics. 

EcoVadis has awarded Sumitomo (SHI) Demag its bronze medal in recognition of its sustainability achievements. Achieving a score of 54 

points, the company narrowly missed out on the silver medal, which required 56 points. Providing CEO Gerd Liebig with both confirmation 

that its sustainability strategy is robust, but equally giving future motivation. Mr Liebig comments: “Sustainability in our mind is a corporate 

strategy and lived practice - for our products, for our production, but also with regard to being a responsible employer. Achieving 

the EcoVadis bronze medal shows that we are on the right track, but at the same time provides an incentive to become even better in the 

coming year.“ 

EcoVadis is a software platform renowned for assessing the sustainability 

of companies, which includes examining the entire supply chain. 

Major competitors of Sumitomo (SHI) Demag are active in this ranking 

too. Based on questionnaires and corresponding reports, points are 

awarded in the categories of labour and human rights, environment, 

sustainable procurement, carbon management and ethics. This wider 

view of sustainability topics from every angle determines the overall 

result. 

“Our customers were approached and asked to rate us. We completed 

this assessment for the first time in 2021, and this year improved 

our performance,” reports Carsten Friedemann, Compliance Officer at 

Sumitomo (SHI) Demag. “The bronze medal is awarded to a company 

receiving a rating that is better than half of the participating organisations. 

By reaching 64 percent, this placed us in the top 40 percent for 

our industry,“ he explains. 

In order to strengthen and further expand this high accomplishment, 

Sumitomo (SHI) Demag is already working on identifying and 

implementing further activities that will lead to achieving an even 

better score in 2023. Most new improvement measures will be in the 

areas of labour and human rights. There is also an increased need for 

action in carbon management, explains Friedemann. “In addition to 

these specific targets, we especially want to focus on environmental 

performance. We can gain more points here by further documenting 

our actions. 

“The topic of sustainability is socially driven and is incorporated 

into companies through appropriate legislation. We expressly welcome 

this, as only sparing use of the planet’s limited resources will 

preserve it for future generations,“ says Friedemann. In addition, an 

increasing number of customers are now demanding evidence of the 

efforts being taken. Last, but by no means least, young employees 

now call for appropriate efforts. „During these times of worker shortages, 

discovering if the company people are considering joining supports 

sustainability is an important aspect of their selection criterion,“ 

he explains. 

Sumitomo (SHI) Demag remains fully committed to sustainability, 

underpinned by its slogan „Act! Sustainably“. As part of this commitment, 

all future innovations must fit within this company framework 

and corporate social responsibility mission statement. Accordingly, 

this includes only manufacturing machines and equipment mindful 

of these ecological aspects. 

Sumitomo (SHI) Demag 

D 90571 Schwaig 

Gerd Liebig, CEO of Sumitomo (SHI) Demag 

Plastics Machinery GmbH, world market leader 

in all.electric injection moulding machines. 

Die EcoVadis Bronzemedaille hat Sumitomo 

(SHI) Demag als Anerkennung für Nachhaltigkeitserfolge 

erhalten.


NEWSLETTER 


K 2022: Improved cost efficiency 

in structural foam moulding 

ENGEL is improving the cost-effectiveness of structural foam moulding at the K show 2022 with new ENGEL e-foam XL multi central gas 

supply units. Another new feature: Sophisticated sample parts produced during the show do not require any additional overhead, but 

leave the injection moulding machine ready to fit with a structured class A surface. 

Structural foam moulding is more popular 

than ever. It saves raw material, energy and 

weight, supporting the objective of producing 

and using plastic parts in a more sustainable 

way by doing so. At K 2022, ENGEL was 

presenting a new type of system technology 

for plastics processors who produce parts 

in parallel on several production cells using 

the structural foam moulding process. Where 

each injection moulding machine previously 

required its own gas supply, ENGEL now 

offers the e-foam XL multi, a central unit for 

supplying several injection moulding machines 

with highly compressed nitrogen for 

structural foam moulding. Only the plasticising 

and control technology is still decentralised 

on the individual machines. This new 

solution sees ENGEL significantly reduce the 

capital outlay for structural foam moulding 

and makes a major contribution to reducing 

unit costs. 

The new modular ENGEL e-foam XL multi 

systems, based on Trexel‘s MuCell technology, 

are offered exclusively by ENGEL. 

Premium surface without additional 

energy input 

appearing on the surface of the foam moulded 

part. Additionally, different surface structures 

can be created directly in the injection 

mould via the cavity coating. 

In addition, the new materials developed 

by Faurecia Interiors for structural foam moulding 

contribute to the high surface quality. 

A talc-filled polypropylene with a recycled 

material content of 30 percent of the IniCycle 

type was being processed during the K show, 

for example. IniCycle is suitable for all physical 

and chemical foam moulding processes. 

The combination of the new system 

technology by ENGEL and MicroJect Advanced 

leverages previously undreamed-of efficiency 

and sustainability potentials in structural 

foam moulding. Structural foam moulded 

parts no longer need to be painted, and 

there is no need for additional energy-intensive 

process technology, such as intermittent 

mould heating, for parts in customer-facing 

applications. 

In general, structural foam moulding requires 

less energy and raw material, and uses 

lower clamping forces, than compact injection 

moulding. The dissolved blowing agent 

improves the flowability of the molten plastics. 

In addition, the foam moulding pressure, 

which is independent of the location, enables 

thicker ribs to be moulded. These effects 

can be used to reduce the wall thickness, 

which has a positive effect on the required 

cooling time and in turn on the cycle time. 

Structural foam moulding conference 

in November 

Another opportunity to experience the exhibit 

in action at first hand is the „foammelt 

– success with little pressure“ symposium, 

which will be held at ENGEL‘s headquarters in 

Schwertberg, Austria, on 22 and 23 November 

2022. The two-day event will provide compact 

details on the state of the art in structural 

and chemical foam moulding. It features 

prominent keynote speakers and is packed 

with practical content. The foammelt conference 

is held annually and is one of the bestattended 

events in ENGEL‘s event calendar. 

ENGEL AUSTRIA GmbH 

A 4311 Schwertberg 

Together with Faurecia, a FORVIA Group 

company, ENGEL was demonstrating the 

huge potential of structural foam moulding 

technology at its trade fair stand. Sample 

parts with a sophisticated surface structure 

were being produced on an ENGEL duo 1000 

injection moulding machine. The new Micro- 

Ject Advanced process developed by Faurecia‘s 

interior systems business unit, Faurecia 

Interiors, based in Hagenbach, Germany, and 

Eschmann Textures International (Gummersbach, 

Germany) was being used here. This 

makes it possible to produce lightweight 

visible components with a very high-quality 

class A surface using only structural foam 

moulding. Among other things, a new mould 

technology is responsible for this leap in development. 

Ceramic coatings in the cavities 

prevent the otherwise typical foam streaks, 

weld lines, tiger stripes or gloss differences 

ENGEL e-foam XL multi powered by Trexel steigert deutlich die Wirtschaftlichkeit 

beim Schaumspritzgießen. (Bild: ENGEL)


NEWSLETTER 


„Personalised medicine can treat the 

most important types of cancer“ 

- Cleanroom specialists create preconditions 

for patient-specific drug production 

Personalised medicine is one of the current mega trends. As a consultant to both the pharmaceutical industry and mechanical engineering, 

Morten Schlothauer has his finger on the pulse. He will be explaining how personalised medicine is changing production methods 

and what this means for cleanroom technology in a presentation at the international trade fair Cleanzone (23 + 24 November 2022). In the 

following interview he gives a first insight. 

Morten Schlothauer, owner of 

Tetragon Management Consulting 

GmbH, advises the pharmaceutical 

industry, among others, and will 

explain at the upcoming Cleanzone 

what the trend towards personalised 

medicine means for mechanical 

engineers and cleanroom 

specialists. (Photo: private) 

Mr Schlothauer, personalised medicine is a 

buzzword, but what exactly does it mean? 

„For me, there are two perspectives: drug 

therapy as we know it is geared towards the 

average person. However, the average person 

does not exist, rather patients are men 

or women, overweight or underweight and 

much more. But hardly anyone is interested 

in that after a drug has been approved. If, in 

future, we continuously collect diagnostic 

data on the course of therapy digitally and 

evaluate it statistically, we will come across 

new interactions, for example. Accordingly, 

especially in multimorbid patients, we will 

be able to optimise the dose for several necessary 

medicines or even reduce their number. 

This could affect the elderly among us, 

for example. It is not uncommon for them to 

take metformin hydrochloride for diabetes II, 

dutasteride and tamsulosin hydrochloride for 

benign prostatic hyperplasia, acetylsalicylic 

acid for mild arteriosclerosis, amlodipine besilate 

for blood pressure, simvastatin to lower 

cholesterol and levothyroxine for mild hypothyroidism. 

However, the more important approach 

targets genes and their function. Cancer 

cells, for example, are different in every patient. 

In the near future, the mRNA technology 

established against Covid will make 

it possible to tailor therapies to the characteristics 

of each specific tumour. To do this, 

tumour cells are taken from the patient and 

examined with the help of gene sequencing. 

Once the cancer cells have been decoded, a 

patient-specific vaccine is produced. This has 

the task of enabling the immune system to 

recognise and fight the tumour. In the process, 

the „foreign“ structure that the immune 

system is supposed to recognise is no longer 

produced in the laboratory, but by the patient‘s 

body itself. The inoculated mRNA is the 

blueprint. This strategy leads to a batch size 1 

drug: specially made for this patient against his tumour.“ 

Where is such personalised medicine already 

used in our everyday lives today? 

„Individualised mRNA therapies are still in development. 

But already today, cancer therapies are mostly tailored to 

the individual patient. They are not applied to all patients 

on a scattergun basis, but only if the tumour has the corresponding 

genetic target structure. Another reality is 

the so-called CAR-T cell therapy. Here, cells are specifically 

programmed; they can then recognise and destroy 

cancer cells. In practice, certain defence cells, so-called T 

cells, are taken from the blood of the patient concerned 

and multiplied using cytokines. They are then genetically 

modified via biotechnological processes and form antigen-specific 

receptors on their surface. These in turn are 

directed against tumour-specific surface proteins. Finally, 

the active substances obtained in this way are administered 

to the patient by infusion. Hospital pharmacies or, 

in certain countries such as Holland, so-called compounding 

centres already produce such individual medicines. 

However, they are expensive: such a therapy is in the range 

of 300,000 euros.“ 

What is your vision for personalised medicine in the 

future? What can we already look forward to today? 

„I am convinced that we will be able to treat the most important 

types of cancer with the existing scientific approaches 

in the foreseeable future - while I am still alive. I am 

convinced that with the existing scientific approaches we 

will be able to treat the most important types of cancer in 

the foreseeable future - during my lifetime.´However, we 

will not be able to achieve a complete cure in every case, 

but sometimes only a prolongation of life by six to nine 

months. We are also getting into an ethical discussion and 

have to find a way to carry out such a therapy at a reasonable 

cost. But I am also convinced that this will succeed.“ 

What does this mean for the way medicines will be 

produced in the future? 

„If the diagnosis determines the therapy 1:1, this leads to


NEWSLETTER 


the aforementioned batch size 1. There will continue to be pharmaceutical 

productions with large batches - for example for metformin. 

However, personalised medicine leads to decentralised, regional production 

in table-top biotech factories with single-use equipment. 

Pumps, controls and electronics work very similarly for a wide variety 

of medicines. In principle, a pharmacy can take over such production. 

Tablets could be printed, capsules filled with micropellets containing 

active ingredients. However, the largest part will be parenterally administered, 

i.e. liquid, drugs, especially for oncology or HIV therapy.” 

How must the cleanroom technology be designed for this? 

„The trend is towards the „gloveless isolator“. For personalised medicine, 

you need cleanroom class A inside the isolator and class C outside 

in the environment.“ 

What should a visitor to Cleanzone who is interested in 

personalised medicine and its manufacture in the cleanroom 

look at particularly closely? 

“It will be exciting to get a sense of the future direction of the overall 

personalised medicine market. It could be, given the amount of data 

in this area, that companies like Google and Amazon will want to get 

in on the action. At Cleanzone, visitors can find suitable partners for 

their own businesses. However, the vaccine manufacturers that became 

known in the course of Corona already have the promising mRNA 

strategies for gene and cell therapy. PCR tests can already be analysed 

in minutes. And at Cleanzone we find well-known machine manufacturers 

and cleanroom specialists who offer, for example, suitable isolators 

and the necessary single-use equipment. In some cases, they are 

already entering into cooperative ventures, thus preparing the way 

for the production of patient-specific medicines today.”außen in der 

Umgebung Klasse C.“ 

cleanzone 

Messe Frankfurt Exhibition GmbH 

Ludwig-Erhard-Anlage 1 

D 60327 Frankfurt am Main 

Telefon: +49 69 7575 6290 

Telefax: +49 69 7575 96290 

eMail: anja.diete@messefrankfurt.com 

Internet: https://cleanzone.messefrankfurt.com 

Supporting customers in the North 

Eleanor Corbett joins Cherwell’s expert team of cleanroom microbiology 

sales specialists 

Cherwell Laboratories, specialist supplier of 

environmental monitoring (EM) and process 

validation solutions for the pharmaceutical 

and related industries, has expanded its cleanroom 

microbiology sales specialist team 

to create additional support for customers in 

the north of the UK. Eleanor Corbett is based 

from Scotland and has been appointed as 

Cherwell’s Business Development Manager 

- North. 

Eleanor Corbett, Cherwell’s new 

Business Development Manager for the North. 

An experienced microbiologist with over 25 

years of laboratory practice, Eleanor is well 

placed to work closely with Cherwell’s customers 

to fully understand and help them meet 

their specific environmental monitoring and 

validation needs. Her microbiology experience 

is extensive, transitioning from technician 

to lab management, plus quality and site management 

roles, predominantly in the food 

and water industries. More recently Eleanor 

has evolved to business development in the 

life sciences sector, so she completely comprehends 

the challenges of working in highly 

regulated environments. 

Emma Millburn, Director of Sales, Cherwell 

Laboratories, said, “We are delighted to 

welcome Eleanor to Cherwell. Her previous 

microbiology and business development 

experience makes her a valuable asset to our 

team and will help Cherwell deepen customer 

relationships to meet their specific requirements. 

Her extensive knowledge in lab 

management, means she understands the 

pressures that come within that area. She is 

also highly knowledgeable about accreditations 

standards and can help our customers 

prepare for these pressures.” 

Commenting on her new role, Eleanor 

said, “I am thrilled to join Cherwell Laboratories 

which is a particularly good fit for me and 

my experience as a microbiologist. Cherwell 

has an excellent reputation for manufacturing 

quality cleanroom microbiology products 

and providing outstanding customer 

service. I’m already enjoying meeting existing 

and new customers and excited to be part of 

the team which is helping them to establish 

the best possible solution for their individual 

needs when developing their contamination 

control strategies.” 

As she is based from Scotland, Eleanor 

is ideally located and readily accessible to 

assist Cherwell’s customers across the north 

of the UK. As part of Cherwell’s team of cleanroom 

microbiology experts, she can offer 

key knowledge in this area and provide direct 

support for its comprehensive range of 

specialist EM and process validation products 

specifically developed for managing controlled 

environments and processes. 

Cherwell Laboratories Ltd 

OX26 4XB BICESTER 

United Kingdom


NEWSLETTER 


MEDICA and COMPAMED present 

themselves as extremely vital 

platforms in turbulent times 

When it comes to searching for business alternatives and reliable partnerships, 

the international healthcare industry is particularly active 

MEDICA and COMPAMED continue to develop in an extremely vital manner. The world‘s leading medical trade fair and the international 

No. 1 for the medical technology supply sector once again impressively underscored their positive results from the previous year with 

strong numbers – despite continuing adverse conditions. A significant increase in bookings on the part of the exhibiting companies was 

followed after four days by a marked increase in the number of trade visitors attending the event. More than 81,000 visitors from various 

sectors of the global healthcare industry came to Düsseldorf, Germany, to attend MEDICA 2022 and COMPAMED 2022 from 14 - 17 November 

2022. Here, a total of more than 5,000 exhibitors from 70 nations offered them a variety of innovations for modern outpatient and 

clinical care – including all components, products and processes for their development and production. The share of international trade 

visitors was 75 percent. After the European countries, trade visitors from South Korea, the USA and groups of visitors from India and North 

African countries were also represented in large numbers. 

„Flying your flag, presenting convincing innovations, 

intensifying networking: These are 

the means of choice for companies to demonstrate 

strength in a challenging market 

environment. MEDICA and COMPAMED, with 

their international appeal and the visitor´s 

high degree of decision-making authority, offered 

the best opportunities for this“, says Erhard 

Wienkamp, Managing Director of Messe 

Düsseldorf, underlining the prominent role 

of both events as platforms for the global 

healthcare business. More than 80 percent of 

all trade visitors are significantly involved in 

important business decisions in their companies 

and institutions. 

Among the top decision-makers who 

visited MEDICA 2022 was, for example, German 

Federal Minister of Health Prof. Dr. Karl 

Lauterbach. He took part in the opening 

event of the 45th German Hospital Day and 

outlined the key points of the planned hospital 

reform. Also among the MEDICA guests 

were H.E. Prof. Ron Prosor, Ambassador of Israel, 

Mona Neubaur, Minister of Economics of 

North Rhine-Westphalia and, among others, 

the Consuls General of Japan and the USA, 

Setsuko Kawahara and Pauline Kao. 

„Cooperation and communication 

are drivers of the industry“ 

MEDICA + COMPAMED in Düsseldorf (Photo: Constanze Tillmann / Messe Düsseldorf) 

In a dynamically changing market environment, 

medical technology companies are 

relying more than ever on cooperative ventures 

– both in terms of production, marketing, 

sales and after-sales services – in order 

to be able to reliably offer customised solutions 

for hospitals and outpatient care across 

national borders. For these reasons, MEDICA 

is virtually predestined as a starting point for 

international business, as Yvonne Glienke, 

Managing Director of the medical technology 

network Medical Mountains, emphasises: 

„MEDICA is an important platform for us 

and the companies in our network to expand 

contacts and find partners for joint projects. 

Both aspects come together at the MEDICA 

TECH FORUM. Here, for the first time, we were 

able to contribute our expertise alongside 

the industry association SPECTARIS and also 

organise a networking evening. Cooperation


NEWSLETTER 


and communication are the driving forces to 

advance the medical technology industry.“ 

The forum, jointly organised by the industry 

association SPECTARIS and Medical 

Mountains, provided an overview of medical 

technology topics that are of particular 

relevance today. Among others, the sessions 

on aspects of product approval, certification 

issues or market peculiarities in relation to selected 

country markets such as the UK, Norway 

or China were very well received by the 

MEDICA audience. 

The strong interest in this is not surprising. 

According to the latest SPECTARIS figures, 

the German medical technology industry 

generates two-thirds of its sales in the export 

business. The German Health Alliance (GHA), 

a broad-based initiative with members from 

industry, logistics, research, the banking sector 

and NGOs, has also set itself the goal of 

boosting this business. Heike Lange, member 

of the GHA management board, points out 

that MEDICA offers the best conditions for 

achieving these objectives: „MEDICA, with 

the participation of numerous international 

exhibitors, offers a good opportunity for GHA 

member companies to meet international 

cooperation partners, whether as visitors or 

while participating as exhibitors. This combination 

often results in expanded opportunities 

for cooperation, especially with regard to 

the export-oriented companies among our 

members.” 

Focus on digitalisation 

– innovations for smart processes 

The following can be summarised with regard 

to the abundance of innovations presented 

and the topics intensively discussed 

in the specialist forums or accompanying 

conferences: Covid is an unchanged „perennial“ 

topic. Not least as a result, the digitalisation 

of healthcare has become an even 

greater focus in almost all countries. And a 

strained personnel and cost situation among 

service providers is driving product development 

toward innovative solutions for smart 

processes. 

In the context of the Covid pandemic 

and the increasing trend towards outpatient 

treatments in healthcare, products and 

services for the point of care, i.e. for patientoriented 

diagnosis and treatment, remain in 

high demand. With the title „COVID-19: The 

Challenge Remains“, the MEDICA LABMED 

FORUM provided a fitting medical perspective 

and bridged the gap in terms of content. 

Current challenges were discussed, based 

on ever new virus variants, and the need to 

improve both diagnostics and therapy (keyword: 

vaccine development) to be adjusted 

accordingly. Detection of new viral variants, 

immunity testing using antibody and T-cell 

assays and approaches to developing a universal 

COVID-19 vaccine were among the topics 

the contributions focused on. 

Meanwhile, the „booster“ for the digitalisation 

of healthcare and the demand 

for smart processes benefits the (digitally 

driven) start-up scene. During the days of 

the trade fair, they were offered a variety of 

options to present themselves. The MEDICA 

CONNECTED HEALTHCARE FORUM as a dialogue 

platform on digital health trends with 

integrated pitch competitions especially for 

start-ups as well as the MEDICA START-UP 

PARK as a large joint booth with again about 

40 companies are worth mentioning. The 

competition for the 11th MEDICA START-UP 

COMPETITION, which annually focuses on 

outstanding digital innovations, was won in 

the final pitch by the start-up IDOVEN from 

Spain with a cloud-based, AI-supported platform 

for ECG analysis. 

Artificial intelligence and robotics with 

practical benefits 

The portfolio of other innovations presented 

by start-ups at MEDICA 2022 ranged from a 

palm-sized system for wireless monitoring of 

the unborn, ultrasound heads with special 

contour-fitting capabilities, to other numerous 

solutions based on artificial intelligence 

(AI), such as for the precise diagnosis of neurocognitive 

disorders based on eye movements 

or the simplified keeping of electronic 

medical records. 

Speaking of help for medical personnel: 

During MEDICA 2022, researchers at Fraunhofer 

IPA presented a system for patient anamnesis 

during admission to clinics that will 

no longer require the immediate presence of 

medical staff. Sophisticated sensor technology 

ensures the automatic recording of vital 

data, and an avatar assists in questioning 

the patient. The trend toward automated 

processes is also confirmed by Axel Weber, 

Vice President Sales Medical Robotics, KUKA 

Deutschland GmbH (Robotics Division): 

„MEDICA is the largest medical technology 

trade fair in the world. We participate in the 

fair because it is the ideal platform for us to 

present our innovative technologies. With 

our robotics, we are shaping the medical 

technology of tomorrow. One trend is the increase 

of more autonomy in systems in medical 

technology. In the future, these will be 

able to perform more and more tasks independently 

thanks to numerous sensors and 

supported by artificial intelligence. This is 

already the case in rehab, for example. In the 

future, though, we‘ll see it more and more in 

surgery.“ 

Golden health tips from winning Olympians 

During all fair days, visitors were able to meet 

victorious Olympians – not only in the form 

of virtual avatars but also live: Heike Henkel, 

Olympic high-jump champion, and Lars Riedel, 

Olympic discus throw champion, were 

the focus of lively interest at the MEDICA 

SPORTS HUB – a new action area in the middle 

of the physiotherapy theme segment. 

In short presentations and supplemented 

by small exercises to participate in, the focus 

was on tips & tricks for healthy training, 

proper nutrition, team success or aspects of 

mental health. On these topics, Heike Henkel 

and Lars Riedel were able to report not only 

from their wealth of experience as sports 

professionals, but also from their current active 

lives. As a certified mental coach, Henkel 

advises competitive athletes, while Riedel is 

a passionate golfer. On every day of the trade 

fair, he invited visitors to participate in a 

special golfer‘s warm-up with regard to establishing 

the perfect rotation of the body. 

As a sought-after brand ambassador in the 

medical sector, Riedel knows MEDICA well: 

„It‘s always exciting here to see how products 

and technology evolve.“ 

Subcontracting: Cutting-edge know-how 

for cutting-edge technologies 

In many cases, an important foundation for 

top performance using cutting-edge technologies 

(e.g., for vital data acquisition) is 

provided by the approximately 700 companies 

presenting themselves at COMPAMED 

in Halls 8a and 8b. They provide the medical 

technology industry with a complete range 

of high-performance components and digitalised 

solutions, such as sensors, batteries, 

chips, biocompatible and ultra-tight coatings 

and radio modules for mobile diagnostic 

devices (including wearables), implants and 

laboratory equipment. Microfluidics is currently 

a particularly popular topic and was 

therefore the subject of two well-attended 

program sessions at the COMPAMED HIGH- 

TECH FORUM held by the IVAM trade association. 

The handling of liquids in the smallest of 

installation spaces is significant for laboratory 

medical test procedures and, as a result of 

the Covid pandemic, has been the focus of 

sustained attention. 

Messe Düsseldorf GmbH 

D 40001 Düsseldorf


NEWSLETTER 


POWTECH 22: Strong comeback for the 

meeting place for process engineering 

Huge joy at getting back together in the halls of the Nuremberg Exhibition Centre: POWTECH, Europe‘s leading trade fair for powders and 

bulk solids, brought delight to exhibitors and trade visitors after the enforced break due to Corona. There were around 9,000 trade visitors, 

increasingly coming from abroad (internationality: 43 percent), to the high-quality meeting of German and international bulk solids professionals. 

The synergies of this year‘s FACHPACK and POWTECH trade show combo gave POWTECH an additional boost: Nearly a quarter 

of FACHPACK visitors were also interested in what POWTECH had to offer. From 27 to 29 September, POWTECH offered 479 exhibitors from 

22 countries in four halls, and 64 top-notch speakers shared useful practical knowledge and demonstrated specific solutions to the challenges 

facing the industry. Visitors were highly satisfied with the quality and professional range that POWTECH once again showcased this 

year in the form of live demonstrations, guided tours and special displays. 

„We are proud of the high-quality networking 

and knowledge platform we have created 

with POWTECH,“ says Heike Slotta, Executive 

Director for Exhibitions at NürnbergMesse. 

„The fact that the processing experts are 

returning after the long break and in the 

current difficult times - and in such a good 

mood despite the current challenges - clearly 

shows that the experts in the sector appreciate 

and need personal exchanges - now more 

than ever.“ The figures from an independent 

survey institute also support this conclusion: 

97 percent of visitors polled said they would 

like to visit POWTECH again next year. 

The internationality of POWTECH has 

increased slightly in terms of visitors: Of the 

approximately 9,000 trade visitors on the 

three days of the show, 43 percent came from 

abroad, from over 70 countries. Austria, Italy, 

Switzerland, the Netherlands, Spain, Poland, 

France, Turkey and the UK were particularly 

well represented. But visitors from the USA, 

South America, Korea, Japan, India and Thailand 

also came to Nuremberg for the international 

industry meeting. 

Trade fair with a training flavour 

Machines from process technology in live 

operation as well as the mix of a sophisticated 

technical programme and dialogue 

from experts to experts make the leading 

European trade show the undisputed meeting 

point for the sector. „POWTECH is a trade 

fair with an educational flavour,“ stresses 

Marianny Eisenhofer, Director of Exhibitions 

at POWTECH. „And that‘s exactly what the 

trade visitors are excited about. The bulk 

solids community is learning and growing 

together - while shaping the future of the 

industry wherever they are.“ 

The exchange of knowledge and the 

spirit of networking were also vividly demonstrated 

in the highlights of POWTECH: in the 

expert forum stagetalks with more than 40 

lectures by top-class speakers, in the guided 

trade show tours on explosion protection, in 

the Networking Pavilion and in the specialist 

forum Pharma.Manufacturing.Excellence of 

the APV and also in the special show on dedusting 

technology by the VDMA Air Pollution 

Control and Drying Technology Division. 

Answers to important questions 

in the industry 

Powder and bulk solids industry thought 

leaders discussed the future of the sector 

and shared practical solutions. This year, the 

focus was on resources and environmentally 

friendly methods, as reflected in the numerous 

presentations. But perennial favourites 

such as efficient powder management of 

metal powders in additive manufacturing 

and continuous manufacturing as well as 

particle characterisation and analysis in pharmaceutical 

production were not forgotten. 

Trade visitors were given a glimpse of the 

future at the „Innovation made in Germany“ 

joint stand, where German startups presented 

their innovations. 

Firecrackers at the live demonstrations 

on explosion protection 

© NürnbergMesse 

In the bulk solids industry above all, fire and 

explosion protection has a special role to 

play. In a total of six live controlled explosions, 

exhibitors demonstrated how protection systems 

work on real industrial facilities. In the 

DSIV Guided Tours on explosion protection, 

the experts at the stands additionally gave


NEWSLETTER 


their views on essential aspects, products 

and problem solutions as well as on German 

and international innovations in the field of 

standardisation, science and technology. 

New potential thanks to trade fair combo 

In this particular exhibition year, FACHPACK, 

the European Trade Fair for Packaging, Technology 

and Processes, was held in parallel 

with POWTECH. An independently conducted 

survey showed that not only were FACH- 

PACK visitors interested in what POWTECH 

had to offer, but a good third of POWTECH‘s 

trade visitors and exhibitors were also happy 

to take advantage of the opportunity to 

expand their knowledge, find inspiration 

and make new contacts at FACHPACK. Both 

trade shows particularly appealed to users 

and manufacturers from the food and feed, 

chemical, pharmaceutical, cosmetics, plastics 

processing and mechanical engineering 

industries. The exhibition combo POWTECH 

and FACHPACK thus brought around 41,000 

trade visitors to see the total of 1,633 exhibitors 

in twelve halls at NürnbergMesse. 

Save the Date 

The next POWTECH will be held in the Nuremberg 

Exhibition Centre from 26 to 28 September 

2023. 

NürnbergMesse GmbH 

D 90471 Nürnberg 

Sustainable film concepts 

for medical packaging 

At this year’s Compamed, the primary focus of SÜDPACK Medica’s presentation will be a tubular film made from the bio-based polymer 

PLA as an alternative to cellulose-based films or comparable films with high water vapor permeability. Not only this, but specialist visitors 

will be able to inform themselves on the wide range of conventional and sustainable coextruded rigid and flexible films for very different 

applications in the medical and pharmaceutical packaging sector. 

The development of sustainable film solutions 

is amongst the key strategic initiatives 

for the SÜDPACK Group. Over the past years, 

numerous sustainable products have been 

successfully launched onto the market for 

various applications. 

Last year, SÜDPACK Medica provided a 

significant impulse for the pharmaceuticals 

industry with its PP-based thermoforming 

film for the manufacture of blister packaging 

for tablets and other pharmaceutical solids 

applications, and this year the company is 

promoting a PLA tubular film for diagnostic 

applications in Düsseldorf. The optimized 

high-performance film represents an alternative 

to cellulose-based films such as cellophane 

or comparable films with high water 

vapor permeability. The material is based on 

renewable raw materials and can be composted 

industrially in accordance with DIN 

EN 13432. Designed in particular for demanding 

diagnostic flow pack applications for 

sterile barrier systems, the film features good 

mechanical properties as well as 

excellent oxygen and water vapor 

permeability. Gamma sterilization 

is possible without visual 

impairments. Like all SÜDPACK 

products, this film can be easily 

and safely processed even in case of high 

output quantities. Above all, however, its 

strengths lie in the use of renewable raw materials 

with a reduced CO2 footprint – thus 

supporting current objectives for climate and 

environmental protection. 

As one of the pioneering manufacturers 

of plastic-based packaging solutions for sterile 

goods, and as tried and tested partners for 

the global medical technology, pharmaceutical 

and diagnostics industries, SÜDPACK Medica 

is also a primary address at the Compamed 

if you’re looking for blister applications. 

For example, the company’s PP film, available 

on the market since 2021, can be viewed in 

Düsseldorf. The material offers optimum barrier 

properties and is characterized by good 

processability on existing packaging lines. 

This makes it possible to produce recyclable 

blister packaging which achieves outstanding 

results in terms of packaging safety and 

efficiency. 

Ecoterm Pharma PurePP Blister 

In addition to this, SÜDPACK Medica will also 

be presenting other coextruded soft and rigid 

films, which can be used as base and lidding 

films for the production of sterilizable 

thermoformed packaging and which can 

be equipped with a wide range of functionalities 

as appropriate for the product to be 

packaged. 

SÜDPACK Medica AG 

CH 6341 Baar 

Flow Pack Planova


NEWSLETTER 


A complete success: Impressive showing 

with „Plan A“ at K 2022, 

the world‘s leading trade fair 

„There is only a Plan A“: Arburg clearly hit the bull‘s eye with this message at the world‘s leading trade fair, K 2022, in Düsseldorf, Germany 

– inspiring countless trade fair visitors in the process. A total of around 30 machine exhibits on its main stand, in the arburgGREENworld 

pavilion in the VDMA Circular Economy Forum, and on partners‘ stands showcased sophisticated applications and technologies in injection 

moulding, additive manufacturing and automation. Sustainability, digitalisation and resilience were the topics that took centre stage. 

„We experienced a huge footfall at our main stand 13A13 and the arburgGREENworld 

pavilion in the VDMA Circular Economy Forum. We 

are very much satisfied with the quantity, quality and internationality 

of the visitors, especially in view of the current conditions,“ said Juliane 

Hehl, Managing Partner responsible for Marketing and Business 

Development, summing up the company‘s successful trade fair appearance. 

„At K, we gave an impressive demonstration of where the 

journey is headed.“ 

Innovative solutions for resource conservation 

„As a machine manufacturer, we are vigorously pursuing a strategy 

towards greater resource efficiency, CO2 reduction and circular economy. 

This is an important issue for our customers worldwide, and 

one that we are bringing to life,“ said Gerhard Böhm, Arburg Managing 

Director Sales and Service. Among the items on show was a demonstration 

of how PIR and PCR recyclates can be processed into high-quality 

products with the help of hardware and software together with 

the new „aXw Control RecyclatePilot“ and other smart controller functions. 

One such product was a tool case in Arburg design, probably 

one of the most coveted give-aways at the entire trade fair. 

Visitors to the arburgGREENworld pavilion were able to gain an 

impressive insight into how Arburg, with its „Plan A“, is playing its part 

in solving a global problem affecting society as a whole. It was there 

that Arburg trainees not only „rocked“ the pavilion but also held numerous 

discussions on the future of plastics as a recyclable material – 

with young visitors in particular. Talks were also held with experts from 

science and industry. And an electric Allrounder produced „Greenline“ 

Guaranteed to turn heads and probably the most sought-after plastic 

product at K 2022 was the premium tool case in Arburg design, manufactured 

on a turnkey system based around a hybrid Allrounder 1120 H. 

(Photo: Arburg) 

anchors from Fischer using plastic based on castor oil. 

High-end injection moulding technology 

At its main stand 13A13, Arburg presented a wide range of sophisticated 

applications and innovative technologies from its entire portfolio: 

injection moulding machines, additive manufacturing, automation, 

plus internally developed control systems, drive trains and digital 

products and services. „We offer our customers everything they need 

not only to work in an energy- and production-efficient way in these 

challenging times, but also to strengthen resilience in the long term,“ 

explained Guido Frohnhaus, Arburg Managing Director Technology & 

Engineering. 

One highlight in terms of injection moulding and mould technology 

was an automated three-component Allrounder Cube 1800, 

which produced a functional component from PP, TPE and POM using 

an 8+8+8-cavity cube mould including new index turning technology 

from Arburg‘s partner Foboha. The challenging assembly process 

took place in the gripper of the associated six-axis robot. 

Another application that attracted a lot of interest was an all-electric 

packaging application. As an alternative to thermoforming, an Allrounder 

720 A with a new 1300 electric injection unit and in the new 

„Ultimate“ performance variant produced thin-walled IML cups with a 

wall thickness of only 0.37 millimetres using the injection compression 

moulding process, achieving an injection speed of up to 400 millimetres 

per second. 

Together with its mould partner Braunform, Arburg used a twocomponent 

Allrounder More 1600 to demonstrate how time and 

costs can be saved by integrating functions, with Luer connectors 

made of PP and TPE as an example. Capping and unscrewing took 

place directly in the mould. Handling was carried out by a Yaskawa sixaxis 

robot, which Arburg will add to its automation range from spring 

2023 as it becomes a system integrator. 

On show as an example of particularly compact automation without 

additional floor space was an interlinked turnkey system based 

around a vertical Allrounder 375 V, which produced a bicycle tool called 

a „tyre lever“ from PIR recyclate. Handling and „ready-to-use“ assembly 

were carried out by a suspended six-axis robot. The Arburg 

Turnkey Control Module (ATCM) ensured 100 percent traceability in 

this application. 

An example of the future of digital production cells was the 

„smart“ turnkey system based around a hybrid Allrounder 630 H. The 

injection moulding machine produced blood tubes from PET and 

communicated with the mould, hot runner controller, material dryer 

and automation via the Gestica control system and OPC UA. The 

„Moldlife Sense“ computer system integrated into the 32-cavity mould


NEWSLETTER 


provided by Arburg’s partner Hack, also enabled monitoring across 

the complete life cycle. 

Digital Center – All-round digitalisation 

In the „Digital Center“ exhibition area, Arburg gave a very hands-on 

demonstration of digital products and services for the injection moulding 

world. In addition to the Arburg host computer system and Remote 

Service ALS, a large number of features for the arburgXworld 

customer portal were presented. New to the MachineCenter app is 

the digital product passport, for example, which indicates the carbon 

footprint of each machine‘s manufacture. Another new feature is a 

machine comparison tool in the MachineFinder app, which has been 

expanded to include equipment options. 

Visitors could see for themselves just how much transparency the 

MachineTerminal app offers. Each exhibit was equipped with an iPad, 

which could be used to access information such as current production 

figures. 

New developments in additive manufacturing 

The Freeformer 750-3X celebrated its world premiere at K 2022. The 

latest machine for Arburg Plastic Freeforming (APF) is systematically 

designed to meet the requirements of the industry. Compared to the 

previous model, the part carrier is around 2.5 times larger – with the 

same external dimensions. The APF process is also around seven times 

faster and more economical. 

Another exhibit, a high-temperature Freeformer 300-3X, demonstrated 

the production of complex components from original material 

Ultem 9085 and a new break-away support material. The additive 

manufacturing portfolio was supplemented with two exhibits from 

Arburg‘s sister company innovatiQ, including the new TiQ2 for entry 

into filament-based industrial 3D printing. 


D 72290 Loßburg 

Strengthening market presence 

in the UK and Ireland 

Underpinning SDUK’s investment in strategic sales, the management team expands 

with the appointment of David Raine to the subsidiary’s Board of Directors. 

Bolstering its market presence in the UK and Ireland, Sumitomo (SHI) Demag Plastics Machinery (UK) Ltd (SDUK) - a wholly-owned subsidiary 

of Sumitomo (SHI) Demag GmbH, Schwaig – is making a number of investments to further advance its sales activities in the UK and 

Ireland. This includes growing the SDUK management team with the appointment of David Raine to the Board of Directors. Assuming 

overall responsibility for sales, Raine, who has worked within the British and Irish plastics industry for 28 years, among others for Sumitomo 

(SHI) Demag and then a Japanese machine manufacturer, returns to the company on December 1, 2022. 

By the end of 2023, David Raine will assume 

overall responsibility for Sumitomo (SHI) Demag 

in the UK and Ireland, succeeding Nigel 

Flowers. After 20 years leading SDUK, Flowers 

will move into new roles within the Group 

before retiring. Under Flower’s leadership, 

SDUK has maintained its position as one of 

the Group’s best-positioned subsidiaries. „We 

would like to thank Nigel Flowers for his 20 

years of commitment, loyalty and successful 

leadership,“ says Group CEO Gerd Liebig. 

“The services and training delivered by 

SDUK are among the most widely used on 

the market. Based on strong technical expertise 

and advice, we now want to expand our 

automation offering and specifically strengthen 

our organisation’s presence in the Irish 

market,“ explains Liebig. “Additionally, we are 

keen to continue increasing and sharing our 

industry-led expertise in both markets. Given 

Nigel Flowers (L) Managing Director of 

Sumitomo (SHI) Demag UK with David Raine, 

new member of the SDUK Board of Directors 

(effective December 1, 2022) 

the current high energy prices, this includes 

showcasing our world leadership in all-electric 

injection moulding machinery. As an 

experienced and recognised expert in the 

plastics industry, David Raine is the ideal can- 

didate with a strong and stable outlook for 

growth.“ 

Sumitomo (SHI) Demag has been present 

in the UK since 1974. Now regarded as 

one of the leading importers of injection 

moulding machines, the SDUK subsidiary 

holds an approximate 15 percent market 

share and specialises in supplying complete 

turnkey solutions. The company’s extensive 

customer base comprises manufacturers of 

automotive, IT, packaging, electronics, pharmaceutical, 

life sciences, construction and 

leisure products and components. Currently 

servicing more than 1,800 injection moulding 

machines in the UK and Ireland, around 400 

customers depend on the SDUK team to deliver 

quality guidance, service support and 

technical expertise. 

Sumitomo (SHI) Demag 

D 90571 Schwaig


NEWSLETTER 


K 2022: Mass production of precision 

parts made of LSR has never been so efficient 

At the K show 2022, ENGEL was joining forces with partner NEXUS Elastomer Systems to provide new impetus to the production of blade 

valves made of liquid silicone rubber (LSR). The fully automated high-end production cell combines maximum output with maximum 

quality consistency, substantially improving cost effectiveness at the same time. 

Whether in cars, medical technology products or packaging, blade 

valves are used in a very wide range of applications. What all of these 

applications have in common is the very strict process consistency requirements 

in terms of injection moulding production. The precision 

of the small parts is safety-relevant. It is essential to combine this requirement 

of quality with maximum efficiency and cost-effectiveness 

in mass production. 

The production cell at the ENGEL stand leveraged the quality and 

efficiency potential for the production of blade valves with a blade 

diameter of 7 mm in the best possible way. It combined an e-victory 

injection moulding machine and smart digital assistance with NE- 

XUS‘s innovative mould and plasticising technology. Production was 

fully automated in a 64-cavity mould with an ENGEL easix articulated 

robot and an integrated vision control system for 100 percent quality 

control. 

Consistent quality with iQ 

Featuring tie-bar-less servo-hydraulic clamping and electric injection 

units, the injection moulding machines from the ENGEL e-victory series 

are predestined for precision applications with LSR. The electric 

ENGEL injection unit ensures high-precision injection. On top of this, 

the machine design features of this model support low-flash, reworkfree 

processing of low-viscosity materials. The moving platen follows 

the mould precisely while clamping force is being built up, which 

results in excellent platen parallelism. Patented force dividers ensure 

that the clamping force is distributed evenly over the entire platen 

face. Even for large multiple-cavity moulds, the cavities near the outer 

edge of the platen are kept closed with exactly the same clamping 

force as those nearer the centre. 

But the highest possible machine movement precision alone is 

not enough. It is in cases of batch fluctuations in the raw material, 

or environmental conditions, for example, due to weather conditions, 

that digitalisation comes into its own. Equipped with the iQ weight 

control smart assistance system from ENGEL‘s inject 4.0 portfolio, the 

injection moulding machine continuously analyses the injection profile 

and readjusts quality-relevant process parameters in the same cycle 

whenever deviations from the reference cycle occur. 

Compact automated 

The excellent accessibility and the space available in the mould area 

are unique on this tie-bar-less injection moulding machine. Where 

multiple-cavity moulds are used, smaller machines than the mould 

size would normally dictate can be used in many cases. This keeps 

both investment outlay and operating costs low. At the same time, 

the productivity per unit of area, a key efficiency indicator in many 

operations, and especially in cleanroom production, is boosted. 

The ENGEL easix articulated robot ensures optimum space utilisation 

on the automation side and also requires very little headroom. It 

connects the injection moulding machine with camera-based quality 

control and the discharge station and adapts flexibly if additional process 

units need to be retroactively integrated upstream or downstream 

of the injection moulding process. 

NEXUS designed the 64-cavity mould with a demoulding device; 

this means that the parts can be picked up very easily and quickly by 

the end-of-arm tooling on the easix robot. 

For high-precision control of the fill quantity, the cold runners in 

the mould are equipped with electric needle shut-off systems. NE- 

XUS‘s Timeshot technology controls the fill quantity as a function of 

the injection time. Each cavity can be controlled individually, even in 

very large moulds with up to 128 cavities. 

A large number of cavities, combined with maximum precision and compact automation, take the 

mass production of blade valves made of LSR to a new level of efficiency. (Picture: ENGEL) 

Blade valves made of LSR are important components 

for functionality and safety in many applications. 

The requirement for the injection molding 

process is „zero defects“. (Picture: ENGEL)


NEWSLETTER 


More transparency and reliability 

NEXUS also specifically developed the ServoMix X20 LSR dosing system, 

which ensures air-free dosing of the liquid silicone rubber, for 

use on the smallest footprint. Via OPC UA, it is networked with the 

injection moulding machine and the MES authentig by TIG, an ENGEL 

Group company. This ensures full process data monitoring and complete 

traceability down to the level of the individual cavities. 

This is the first time that ENGEL is demonstrating networking of 

the injection moulding machine and the LSR dosing unit via OPC UA 

in line with the Euromap 82.3 standard live at a show. What becomes 

clear is how networking makes production more transparent and reliable 

and how work processes are accelerated. 

The process data of the dosing unit are available during ongoing 

production in the CC300 control system of the injection moulding 

machine and can be used for even more precise process monitoring 

and continuous process optimisation. The dosing parameters are stored 

in the mould‘s part data record. This means that they are immediately 

available at the machine control when the mould is set up again 

ENGEL AUSTRIA GmbH 

D 4311 Schwertberg 

FDA-compliant weighing 

table made entirely 

of stainless steel 

Precise work is the top priority in pharmaceutical production - this also 

includes the extremely precise weighing of the smallest quantities of 

products or active ingredients. 

Where exact measurement results are required, weighing tables 

or anti-vibration tables are used. These tables are designed in such a 

way that they absorb vibrations, e.g. caused by movements in the environment, 

thanks to their enormous weight and structural stability 

and decoupling, and stabilize the measuring devices such as analysis 

and microbalances during use, thus preventing measurement inaccuracies 

as best as possible. 

An anti-vibration or weighing table usually has an integrated stone 

plate that is mounted on rubber blocks. Such a stone or granite 

slab is increasingly presenting clean room operators and pharmaceutical 

manufacturers with the problem that FDA approval is not available 

for a natural material such as granite. 

Friedrich Sailer GmbH, as an innovative outfitter for cleanrooms 

and pharmaceutical companies, has developed a solution for this: the 

Sailer weighing table made of stainless steel. This anti-vibration table, 

which is suitable for cleanrooms and is made of material AISI 304, has 

the Sailer-typical brushed finish with a surface roughness of Ra < 0.8 

µm. Due to its densely laser-welded stainless steel table top construction 

with a filling of ultrahigh performance concrete (UHPC) and its 

high weight of 130 kg, it is extremely low in vibration. The upper plate 

is also vibration-decoupled from the substructure via 4 dampers made 

of FDA-compliant plastic. All of the materials used for the table are 

FDA-compliant, as is the surface quality. 

The Sailer weighing table ensures maximum stability of a scale 

and reduces vibrations to a minimum. Tests with a high-performance 

analytical balance from Mettler Toledo (model XPR225DR) have shown 

that measurement accuracies of 0.1 mg to four decimal places are stably 

achieved in both cleanroom and uncontrolled conditions. 

This means that there is now the possibility of doing without 

non-FDA-compliant material in the pharmaceutical environment and 

using a solution for safe and precise weighing that meets all the specifications 

for a clean room-compatible design. 

Friedrich Sailer GmbH 

Memminger Str. 55 

D 89231 Neu-Ulm 

Telefon: 0731 985900 

eMail: info@friedrich-sailer.de 

Internet: http://www.friedrich-sailer.de/reinraum


NEWSLETTER 


Packaging 4.0: In top form 

throughout the line 

Automation and digitalisation are the megatopics, which affect manufacturing industry today and in the future. It is for this reason, that 

MULTIVAC will be presenting itself at COMPAMED 2022 as a supplier of integrated solutions for the healthcare sector - and will also be 

demonstrating its expertise in automation with some highly efficient line concepts. The highlights among the exhibits include a line for 

producing and marking combi packs containing a syringe, filter and vial, as well as a conveyor belt labeller for wrap-around labelling of 

cylindrical containers. 

Starting with the infeed of sensitive products and going through the 

packaging process itself right up to the end-of-line operation: There 

is much more waiting for visitors to MULTIVAC than just a range of 

products, which are perfectly designed for the needs of the medical 

and pharmaceutical industries. The focus in particular is on the comprehensive 

expertise in automation and complete lines by a ma-chine 

manufacturer, which has mastered even the most demanding challenges 

with its range of tailored solutions - and can therefore offer its 

customers real added value in terms of process reliability, efficiency, 

production transparency and pack security. 

High-output thermoforming packaging line 

for producing combi packs 

The heart of the line is a RX 4.0 thermoforming packaging machine in 

GMP design - a powerful model in the innovative X-line generation, 

with which MULTIVAC is supporting the digitalisation of packaging 

processes and Industry 4.0/IoT solutions. The RX 4.0 with its complete 

housing, which can be viewed at the trade fair in Düsseldorf, is laid out 

to produce a combi pack with a syringe, filter and vial: MULTIVAC‘s new 

H 800 SCARA robot, which is located at the machine infeed, loads the 

various products precisely into the pack cavities, and the integrated 

H 242 handling module converges the packs at the machine outfeed, 

so that they are perfectly aligned for downstream processes such as 

box packing. A high-performance and very reliable InteliJet HD digital 

printer from BELL-MARK is integrated into the RX 4.0 for printing the 

packs precisely and in compliance with legislation. 

Thanks to comprehensive sensor systems, a state-of-the-art machine 

control and networking with the MULTIVAC Cloud, the RX 4.0 

elevates the packaging process for sensitive products in the medical 

and pharmaceutical industries to a new level - both in terms of output, 

machine availability and flexibility, as well as pack quality and process 

reliability. The RFID-coded X-tools are an additional guarantee of 

maximum performance. Thanks to their highly developed actuating 

system, they enable the die to be changed quickly and reliably during 

product changes. And last but not least, the whole line can also be 

controlled conveniently and intuitively by the packaging machine‘s 

HMI, which has been im-proved still further, particularly as regards 

user-friendliness. 

Modular carrier system as the basis for the controlled 

transporta-tion, loading and buffering of syringes 

Another eye catcher on the stand is a modular carrier system with 

integrated H 242 handling module for loading syringes into combi 

packs. The integrated and high-performance vision system ensures 

that, even at high output, all the packs are inspected rigorously for 

completeness of content. The system also checks, whether the individual 

products have been loaded correctly into the pack cavities. 

Wrap-around labelling of cylindrical containers 

MULTIVAC will be demonstrating the rapid and precise labelling of 

round or oval bottles and glass jars with its L 320 conveyor belt labeller, 

which leaves nothing to be desired, when it comes to output 

capability and above all flexibility. Since the labeller is constructed of 

standard modular elements, this model can be perfectly designed for 

the requirements of the particular sector. In addition to this, the L 320 

can easily be upgraded with additional components, such as the MRT 

100 rotating table, so that the products can be brought directly to the 

label-ling process, or buffered if required. 

Labels can be positioned on all sides, as well as over the pack edges 

or as wrap-around labels. The application of sealing labels is also 

possible. Thanks to a minimum of format parts, which can be changed 

very quickly, the labeller can be converted to different products within 

a short period of time. The rapid change of label rolls, together with 

the use of low-maintenance components, also contribute to the labeller‘s 

high level of availability. 

MULTIVAC Sepp Haggenmüller GmbH & Co. KG 

D 87787 Wolfertschwenden


NEWSLETTER 


A hybrid Allrounder 630 H in clean-room design communicates with the mould, hot runner controller, material dryer 

and automation via the Gestica control system and OPC UA. (Photo: Arburg) 

Digitally networked production cell 

communicates with mould and periphery 

An especially „smart“ exhibit and an example for the future of digital production cells is the turnkey system based on a hybrid Allrounder 

630 H: the injection moulding machine communicates via the Gestica control system and OPC UA with mould, hot runner controller, material 

dryer and automation. The „Moldlife Sense“ computer system is integrated into the 32-cavity mould provided by Arburg’s partner 

Hack, and enables monitoring across the complete life cycle. 

In this example, the practical advantages of 

digitalisation and automation in plastic processing 

are especially evident in the production 

of blood vials for medical technology. 

New interface: machine communicates 

with mould 

The „Moldlife Sense“ computer system enables 

the complete mould life cycle to be monitored. 

(Photo: Arburg) 

The „Moldlife Sense“ computer system enables 

the complete life cycle to be monitored. 

Arburg has implemented the new solution 

for communication between mould 

and machine together with the cooperation 

and development partner Hack. A hybrid 

„Packaging“ Allrounder 630 H in clean-room 

design produces, with the 32-cavity mould 

of Hack, transparent blood vials made of 

shatterproof PET. The location of changes 

occurring at the mould can be precisely 

assigned with the help of a sensor system. 

Two cameras take images or videos, e.g. of 

mould separation and parts ejection. There 

are also four displacement as well as four 

knock sensors for the tie-bar guidance. In 

this way, process changes can be detected 

at an early stage and damage to the mould 

reliably avoided. The data is passed directly 

to the machine control system via an OPC 

UA interface. 

Gestica features for quick and 

secure working 

In addition to the mould, the central Gestica 

control system, hot runner controller (Mold 

Masters), a special PET material dryer (Eisbär) 

and the automation (Waldorf ) are connected 

to the central Gestica control system via 

OPC-UA. In this way, the temperatures of hot 

runner and dryer can be monitored, and the 

automation started and stopped directly via 

the Gestica. The hot runner controllers also 

communicate via the Euromap (EM) 82.2, 

and the automation via the new interface EM 

79. Further features such as the „aXw Control 

PressurePilot“ controller function and the 

„aXw Control MeltAssist“ provide additional 

process reliability and enable comfortable 

and quick working. 

In-line quality assurance 

32 blood vials are produced in a cycle time 

of around 7.5 seconds, and removed via a side-entry 

robot made by Waldorf. The encapsulated 

automation is equipped with four 

cameras, which check that the components 

are straight. A QA request can also be called 

up at the push of a button. 


D 72290 Loßburg


NEWSLETTER 


HTE & TEE301 Expand Sensing 

Element Series for Humidity and 

Temperature 

The new HTE301 and TEE301 models see E+E Elektronik 

expand its digital sensing element portfolio to include 

two cost-optimised product variants. 

Premiere at 

PDA: Prefilled 

Syringes with 

RFID-Labels 

Austrian sensor manufacturer E+E Elektronik is expanding its digital sensing element portfolio 

to include two new product variants. The HTE301 humidity and temperature sensing 

element and the TEE301 temperature sensing element offer excellent measurement accuracy 

and a wide application temperature range from -40 °C to 125 °C (-40 °F to 257 °F). 

The small 8-pin DFN package with its I2C interface and four individually configurable I2C 

addresses is ideal for state-of-the-art, demanding designs. 

Premiere at PDA: Prefilled 

Syringes with RFID-Labels 

The HTE and TEE301 sensing elements are 

part of the new sensing element generation 

by E+E Elektronik. Offering the same accuracy 

values, they are cost-optimised variants of 

the HTE and TEE501 sensing elements introduced 

earlier this year. With a different data 

format (16-bit unsigned integer) and pin assignment 

compared to the 501 series, the 301 

series allows easy upgrade of existing applications 

with minimal integration effort. 

HTE301 humidity and temperature sensing 

element 

The HTE301 sensing element impresses with 

a measurement accuracy of up to ±1.8% RH 

(incl. hysteresis) and ±0.2 °C. It features an 

integrated constant current heater which 

keeps the element at approx. 2-3 °C overtemperature 

and prevents condensation 

forming on the sensing element. This results 

HTE301 and TEE301, the new humidity and 

temperature sensing elements from E+E Elektronik. 

(Photo: E+E Elektronik Ges.m.b.H.) 

in excellent measurement performance and 

fast response time even in conditions with 

high humidity. On top of this, the proprietary 

E+E sensor coating protects the active sensor 

surface of the HTE301 against contamination 

and corrosive deposits. 

TEE301 temperature sensing element 

The TEE301 sensing element measures the 

temperature with an accuracy of up to ±0.2 

°C. Thanks to its wide temperature range, the 

sensing element is versatile, providing a reliable 

and cost-effective solution for demanding 

temperature measurement tasks. 

DFN package with I2C interface 

Both sensing elements are available as an 

8-pin DFN package with dimensions of just 

2.5 x 2.5 x 0.9 mm3 to support easy integration 

into existing applications. The I2C interface 

enables robust data communication, 

supporting communication speeds up to 

1,000 kHz. The sensing elements offer four 

selectable I2C addresses as well as alert and 

reset functions. 

E+E Elektronik Ges.m.b.H. 

Langwiesen 7 

A 4209 Engerwitzdorf 

Telefon: +43 7235 605 0 

Telefax: +43 7235 6058 

eMail: info@epluse.com 

Internet: http://www.epluse.com 

Pharma label expert Schreiner Medi- 

Pharm and SCHOTT Pharma, the specialist 

in drug containment and delivery 

solutions for medications, have 

been engaged in a partnership for several 

years. Its objective is to develop 

new smart concepts that add functional 

value to prefilled syringes. At the 

PDA Universe of Pre-Filled Syringes 

and Injection Devices Conference in 

California, both companies have now 

for the first time presented a coordinated, 

newly developed solution to 

equip prefilled syringes with RFID. The 

combination of syringe and smart label 

opens up diverse opportunities to optimize 

hospital routines, among other 

things. 

The partnership between Schreiner MediPharm 

and SCHOTT Pharma has previously 

been focused primarily on equipping 

COC syringes with analog functional 

labels. Now the two pharmaceutical 

packaging experts are digitizing prefilled 

syringes. What makes the new RFID-Labels 

special is the combination of marking 

the syringe with its unique, digital 

identity. This enables optimized processes 

in hospital inventory management 

and patient care and documentation as 

well as the identification of a medication 

and a medical device. In addition, digital 

first-opening indication to protect the integrity 

of the syringe is possible. 

To successfully implement this innovation 

and to ensure impeccable RFID


NEWSLETTER 


The New SmartVane 

Rotary Vane Pump for 

Mass Spectrometry 

– Hermetically sealed pump housing 

– Optimal conditions for laboratories 

– Environmentally-friendly stand-by drive 

The smart RFID Syringe Label combines 

marking of a syringe with its 

unique, digital identity. 

functionality in terms of good performance and adequate 

range, various characteristics of the prefilled syringe 

must be considered. Aside from the material such as COC, 

PP, or glass, which can affect range and trouble-free reading 

of the tag, syringe size and diameter play a decisive 

role: The smaller the syringe the less space for product 

marking and integration of the RFID chip. Plus, the smaller 

the tag the shorter usually its read range. In addition, the 

curvature may affect performance, especially in the case 

of small syringe diameters. 

The dielectric properties of the medications contained 

in the syringe play a role as well. Especially waterbased 

active ingredients have a negative impact on the 

radio transmission performance of a tag. This requires 

precise positioning of the RFID-Label and integrated inlay 

according to the liquid and fill level. Additionally, special 

data standards for identification and tracking on unit level 

such as UnitVisID or GS1 must be considered, which 

enable all relevant stakeholders to interpret and use the 

data, as well as integration in the respective infrastructure. 

Schreiner MediPharm and SCHOTT Pharma adapt the 

solution to the customer’s specific requirements to ensure 

optimal functionality from production to final use. This 

helps enhance product safety and avoid potential medication 

errors. 

The new solution from Schreiner MediPharm and 

SCHOTT Pharma was presented for the first time at the 

“PDA Universe of Pre-filled Syringes and Injection Devices 

Conference” from October 18 to 19, 2022 in the United 

States. Arne Rehm, Senior Product Manager RFID/NFC 

Solutions at Schreiner MediPharm, and Tom van Ginneken, 

Head of Global Product Management for SCHOTT 

TOPPAC®, delivered a joint presentation under the motto 

“Making Pre-filled Syringes Smart” at the event. 

Schreiner MediPharm 

D 85764 Oberschleissheim 

Pfeiffer Vacuum, a leading provider of vacuum technology, introduces 

the first rotary vane pump for mass spectrometry with a hermetically 

sealed pump housing. The SmartVane serves as a backing pump 

for mass spectrometers (ICP-MS, LC/MS), for applications in environmental 

and food analytics, as well as in pharmaceutical and clinical 

analytics. This vacuum pump is designed to ensure that no oil leaks 

occur therefore preventing any contamination. Thanks to the integrated 

motor, no conventional seal is needed, which means that the 

SmartVane has longer maintenance intervals. 

As Marcel Merkardt, Product Manager at Pfeiffer Vacuum, explains: 

“With SmartVane, oil leaks in the laboratory are a thing of the past. 

Here, we combine the advantages of the tried-and-tested rotary vane 

pump principle with a revolutionary sealed design. In practice, this 

means that you benefit from the familiar high performance of a rotary 

vane pump, but without any disadvantageous oil leaks.” 

The low noise level of the SmartVane ensures ideal conditions in 

the laboratory. With its typical operating pressure of less than 10 hPA, 

it is quieter than other pumps used for this type of application. This 

makes it possible to carry out even challenging tasks in a pleasant 

working environment. Its compact design makes it easy to incorporate 

in existing systems. In addition, the pump offers intelligent communication 

options and can be used as a plug-and-play solution in 

combination with existing devices. 

An additional key benefit is the pump’s sustainability. The Smart- 

Vane has an integrated energy-efficient IPM motor with a stand-by 

function. Its low power consumption automatically reduces the operating 

costs and CO2 footprint. 

Pfeiffer Vacuum GmbH 

D 35614 Asslar


NEWSLETTER 


Digital Sensing Module for Cost-efficient 

Humidity and Temperature Measurement 

The HTM502 sensing module makes it possible to achieve precise humidity and 

temperature measurement without major integration effort. 

The HTM502 sensing module by Austrian sensor manufacturer E+E Elektronik offers a cost-effective solution for humidity and temperature 

measurement. It is characterised by easy implementation, high accuracy and reliability. Integration and interchangeability via the 

I2C interface allow for rapid project implementation. The 

integrated sensor protection and the mechanically robust enclosure 

support a wide range of applications. The module is 

particularly suitable for price-sensitive applications in the HVAC 

sector but also for industrial applications. 

Rapid integration via I2C 

The I2C interface allows for easy integration of the humidity and temperature 

module, meaning that projects can be quickly implemented. 

The HTM502 offers two measurement operating modes (singleshot 

or periodic measurement mode) and supports communication 

speeds up to 1000 kHz. Thanks to the low supply voltage of 2.35 – 3.60 

V and the low current requirement, the module is also suitable for applications 

with low energy consumption. 

Easy installation and replacement 

HTM502 digital sensing module 

for humidity and temperature. 

(Photo: E+E Elektronik Ges.m.b.H.) 

The HTM502‘s design lends itself to easy installation without additional 

implementation overhead or soldering work. Thanks to the 4-pin 

connector plug, the sensing module can quickly be replaced in the 

field. 

Excellent measurement accuracy, robust design 

The HTM502 sensing module measures humidity and temperature 

with an accuracy of ±2.0% RH and ±0.3 °C (0.54 °F) and can be used in 

applications between 5 °C and 60 °C (41...140 °F). The robust enclosure 

gives the module great mechanical stability and ensures ease of handling 

by preventing accidental contact with the sensing element. The 

integrated E+E sensor coating protects the sensing element against 

dirt and corrosion, improving measurement performance and longterm 

stability in harsh and demanding environments. 

E+E Elektronik Ges.m.b.H. 

Langwiesen 7 

A 4209 Engerwitzdorf 

Telefon: +43 7235 605 0 

Telefax: +43 7235 6058 

eMail: info@epluse.com 

Internet: http://www.epluse.com 

Impressum: 

cleanroom online / W.A. Schuster GmbH · Mozartstrasse 45 · D 70180 Stuttgart · Tel. +49 711 9 64 03 50 · Fax +49 711 9 64 03 66 

info@reinraum.de · www.cleanroom-online.de · GF Dipl.-Designer Reinhold Schuster · Stgt, HRB 14111 · VAT DE 147811997 

Original texts and images 

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