Newsletter_11-2024_EN

EN 11/24 

HPAPI Manufacturing: 

Here‘s How 

Protective 

Clothing Can 

Help Keep Workers 

and Products Safe

HPAPI Manufacturing: 

Here‘s How Protective Clothing Can 

Help Keep Workers and Products Safe 

Author: Steve Marnach 

Highly Potent Active Pharmaceutical Ingredients (HPAPI) are a primary 

source of medical innovation. Their ability to target cells selectively 

enables researchers to develop tailored, patient-centred care 

with maximal efficacy but minimal side effects. Such is the impact of 

HPAPI on medical development that the market is growing at more 

than 10% annually and is forecast to reach US $40 billion by 2027. (1) 

However, HPAPI are classified as hazardous substances because 

even limited exposure could impact workers‘ health. At the 

same time, high-value pharmaceutical products containing HPAPI 

are vulnerable to contamination by foreign materials like skin cells 

or sweat from workers. Selecting appropriate protective clothing is 

critical to addressing both risks. 

Safety risks and how cleanroom garments protect workers 

Pharmaceutical workers could come into contact with HPAPI during 

several stages of production, like preparation of ingredients, formulation, 

sterilisation, fill and finish, and cleaning and disinfecting. 

The primary risk of exposure is inhalation, followed by dermal exposure. 

Personal protective equipment is essential to protect workers 

from exposure to HPAPI in any form. 

A critical step in protecting workers from these hazards is a risk 

assessment. During this process, key questions can help to identify 

the hazards and assess the risks. The assessment should indicate 

the physical state of the HPAPI (solid, liquid, waxy, or gas). It should 

also list how each ingredient could enter the body systems (inhalation, 

accidental injection, dermal absorption, etc.) depending on the 

manufacturing activity inside the cleanroom. Lastly, the risk assessment 

should highlight the PPE requirements to mitigate these risks. 

European regulation 425/2016 lays down requirements for the 

design and manufacture of PPE. Specific tests are used to verify the 

performance of a garment depending on the physical state of the 

hazardous substance: 

– EN ISO 6530 or EN ISO 17491-4 test the liquid penetration 

of a garment. 

– EN ISO 13982-2 tests the solid particle penetration of a garment. 

– EN ISO 6529 or ASTM F739 test the liquid or gas permeation 

of a garment. 

Contamination risks and how cleanroom garments 

protect product quality 

Research shows that human beings represent the primary risk of 

product contamination in cleanrooms. 75% of contamination comes 

from skin flakes and bacteria that the human body constantly sheds 

or from fabric fibres and particles shed from protective garments. 

(2) Specific tests are used to verify the performance of a garment in 

terms of cleanliness or barrier to skin flakes shed by the wearer: 

– EN 143 is a particle filtration efficiency test. 

– ASTM F2101 is a bacterial filtration efficiency test. 

Besides the quality tests that measure permeation performance, garments 

designed for operator comfort and breathability can help to 

limit the number of particles shed by an operator. Breathable materials 

like DuPont Tyvek® material are low linting which can help 

reduce operator sweating and help to lower the contamination risk. 

Selecting appropriate protective clothing is critical to 

protecting workers in HPAPI manufacturing. 

Breathable materials like DuPont Tyvek® help lower 

contamination risk in cleanrooms. 

www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 11-2024 

page 2/38

Garments that allow freedom of movement have a similar effect, 

reducing operator discomfort and, therefore, particle shedding. 

GMP1 Annex provisions for HPAPI manufacturing cleanrooms 

Good Manufacturing Practice (GMP) Annex 1 (3) classifies cleanrooms 

into four grades using the maximum allowable number of airborne 

particles per cubic meter of air. Grade A has the most stringent 

criteria, with a maximum total number of particles of 3,520 ≥ 0.5 

µm/m3. Grade D has the least stringent requirements with a maximum 

total number of particles of 3,520,000 ≥ 0.5 µm/m3. GMP Annex 

1 specifies the garment requirements for each cleanroom class 

based on activity type and contamination risk. 

Grade A/B cleanrooms present a lower risk of exposure to hazardous 

materials, but workers could still be exposed to finished-dose 

HPAPI. On the other hand, preventing product contamination 

in Grade A/B cleanrooms is highly critical. Protective garments in 

these cleanrooms should meet both the GMP Annex 1 requirements 

and the PPE safety requirements. 

Operators handle larger quantities of HPAPI at higher potencies 

in Grade C/D cleanrooms compared to Grade A/B. For this reason, 

operator protection takes priority over cleanliness requirements in 

these environments. Protective garments are categorised according 

to their protection levels. 

A safer future for HPAPI production 

HPAPI manufacturing has enabled significant pharmaceutical developments 

due to their targeted pharmaceutical action. The market 

growth in this sector highlights the importance of HPAPI manufacturing 

and the vital need to adhere to cleanroom requirements for 

both operator protection and preventing product contamination. 

GMP Annex 1 categorises cleanrooms according to the risk of 

exposure to hazardous substances. Different garment requirements 

are specified according to the risks associated with the activities. At 

the same time, PPE regulations specify the level of protection required 

for operator safety depending on the form of the hazardous substance 

and the risk of exposure. It is vital for HPAPI manufacturers 

to understand the various regulatory requirements and to select the 

best protective garments for their applications. 

To download DuPont’s The HSE Manager’s Guide to Cleanroom 

Garments for HPAPI Manufacturing visit: https://www.dupont.co.uk/personal-protection/pharmaceutical-industries-ppe. 

html?src=EMEA_EN_SafetyPersonalProtection_GB_PR_External_ 

HPAPIEguide#hpapi 

(1) https://www.marketsandmarkets.com/Market-Reports/high-potency-api-market-36582475.html 

(2) Ramstorp M., „Introduction to Contamination Control and Cleanroom 

Technology“, Wiley VCH, 2000, Weinheim (Deutschland) 

(3) https://health.ec.europa.eu/system/files/2022-08/20220825_gmpan1_en_0.pdf 

November 2024 

Dear cleanroom professionals, 

Reading newspapers and watching the news 

every day, I find it increasingly difficult not to 

talk about the economic environment in the 

foreword. Decarbonisation, deindustrialisation, 

gender, security and sustainability, jobs and 

inflation, migration and skills shortages. And 

on top of that, today‘s election in the USA. 

How are we supposed to be able to concentrate 

on our work? 

We‘ve closed the door, switched off the 

smartphone and put together another interesting 

newsletter with exciting articles for you: 

> Here‘s How Protective Clothing Can Help 

Keep Workers and Products Safe 

> Automated cleaning process for printed 

photovoltaic modules manufactured using 

roll-to-roll Technology 

> Material airlocks for GMP, clean rooms 

or safety areas for every building situation 

> Filling of medicines under cleanroom 

conditions with a hygienic handling robot 

> Digitalized, Sustainable Battery Cell 

Production 

> . . . 

With kind regards 

Reinhold Schuster 

DuPont de Nemours (Luxembourg) Sa rl 

Rue General Patton 

L-2984 Contern 

Telefon: +352 3666 5111 

eMail: mycustomerservice.emea@dupont.com 

Internet: http://dpp.dupont.com 


page 3/38

The compact cleaning module can be adapted 

to the respective web width and easily integrated 

into roll-to-roll production lines. 

(Photo credit: Research project team PV-CO2) 

The automated CO2 snow jet cleaning system ensures 

that burrs are reliably removed in a process that is suitable for 

industrial use. The cleaning effect is based on a combination 

of thermal, mechanical, solvent and sublimation effects. 

(Photo credit: Research project team PV-CO2) 

quattroClean snow jet technology for cleaning electrodes after laser structuring 

Automated cleaning process for printed 

photovoltaic modules manufactured using 

roll-to-roll technology 

Roll-to-roll production lines enable printed photovoltaic modules to be produced 

particularly cost-effectively. To avoid short circuits, however, conductive burrs created 

when the front electrode is laser structured previously had to be removed manually 

in a way that was not compatible with the industrial process. In a joint project, a 

fully automated CO2 snow-jet cleaning solution was developed that can be integrated 

into the production line to eliminate this problem. 

With a layer thickness of between 0.5 and 

one micrometer and high efficiency even 

when solar radiation levels are low, flexible, 

printed photovoltaic cells open up a wide 

range of applications when it comes to supplying 

solar energy. In the field of printed 

photovoltaics, the roll-to-roll process offers 

major advantages in terms of production 

speed, volume and costs. The five layers 

of the modules, which are based on organic 

and perovskite semiconductors, can be 

processed individually. The bottom layer - a 

transparent IMI electrode (structure: indium 

tin oxide, silver, indium tin oxide) - is 

structured by laser. Burrs are formed along 

the structured edges, which are conductive 

and protrude a few micrometers from the 

surface. If they are not removed, they will 

cause damage and short circuits due to the 

thinness of the modules. The current practice 

is to remove the burrs mechanically at 

very low web speeds. However, there is a 

risk of the structured layers becoming damaged 

due to the mechanical impact. 

Development of an automated, 

in-line cleaning solution 

To solve this problem when manufacturing 

printed photovoltaic modules on roll-toroll 

production lines, the Institute Materials 

for Electronics and Energy Technology (I- 

MEET) together with the Solar Factory of 

the Future at Friedrich-Alexander-Universität 

Erlangen-Nürnberg, Sciprios GmbH 

and acp systems AG, initiated the “PV-CO2” 

research project funded by the Federal Ministry 

for Economic Affairs and Climate Action 

(BMWK). The aim was to develop a fully 

automated CO2 snow jet cleaning system 

for industrial use based on acp‘s quattroClean 

snow jet technology. This is a dry process 

which is used for full-surface and selective 

cleaning applications. The cleaning medium 

is liquid carbon dioxide recycled from 

chemical production processes and energy 

generation from biomass. The carbon dioxide 

is guided through a wear-free two-substance 

ring nozzle and expands on exiting to 

form fine snow crystals. These are bundled 

by a separate jacket jet of compressed air 

and accelerated to supersonic speed. When 

the easily-focused jet of snow and compressed 

air impacts on the surface to be cleaned, 


page 4/38

a combination of thermal, mechanical, solvent 

and sublimation effects occur, which is 

the basis of the cleaning action. The crystalline 

carbon dioxide sublimates completely 

during the process, leaving the treated surfaces 

completely dry. 

Proven efficient burr removal 

and enhanced efficiency 

A roll-to-roll pilot line was set up for cleaning 

the laser-structured electrode substrates 

and fitted with several quattroClean 

snow jet nozzles arranged above the electrode 

web. The first step was to optimize the 

jet parameters so as to significantly reduce 

the burr height without damaging the electrode. 

In addition to the capillary diameter, 

which determines the flow rate of the 

liquid carbon dioxide, and the pressure of 

the compressed air jacket, the distance between 

the nozzle and the substrate needed 

to be adjusted, as well as the web speed and 

the inclination of the nozzles in relation to 

the substrate. After each cleaning process, 

the maximum burr height was measured by 

confocal microscopy. This procedure was 

repeated for a large number of parameter 

combinations until an optimum cleaning 

result was achieved. 

To evaluate how deburring affects 

photovoltaic efficiency, organic photovoltaic 

modules eight centimeters wide were 

produced on substrates that had been cleaned 

using the CO2 snow-jet process. These 

were compared with modules produced on 

untreated substrates and manually-cleaned 

substrates of the same size. As expected, 

the modules on the uncleaned substrate 

had a high leakage current, which reduced 

Photovoltaic Cell Efficiency (PCE ) to 2.3 

%. For the manually cleaned modules, the 

PCE was 4.8 %, and for the modules cleaned 

using the CO2 snow-jet process, it was as 

high as 5.3 %. The difference in efficiency is 

explained by the fact that manual cleaning 

causes scratches to be formed on the electrode, 

which can significantly reduce the 

The 300R2RCompact R&D platform, into which 

the cleaning solution can be easily integrated, 

enables a wide range of roll-to-roll coating 

and printing experiments to be carried out. It 

can also be used to upscale laboratory tests to 

small production series. (Photo credit: Sciprios 

GmbH) 

active area. This is because the scratched 

area does not generate any current and also 

because areas can be cut off from the charge 

extraction by the scratch. 

Dark Lock-In Thermography (DLIT) was 

used to confirm that deburring is responsible 

for the difference in efficiency of the differently-treated 

substrates. 

Ready for series production 

for various applications 

The thickness of the layer stack (without the PET layer, which serves as a carrier material 

for the layer stack) of a printed solar cell (ETL electron transport layer, AL active layer, HTL 

hole transport layer, AgNW silver nanowire electrode, IMI electrode is laser structured) is 

well below one micrometer. (Photo credit: Research project team PV-CO2) 

The fully automated cleaning solution has 

now been integrated into the standard production 

process for printed photovoltaics at 

the Institute Materials for Electronics and 

Energy Technology. Here, an array with seven 

nozzles is used to reliably remove the 

laser-induced burrs on a 25 cm-wide web. 

At Sciprios, too, the CO2 cleaning process is 

now one of the equipment options for rollto-roll 

production lines for printed photovoltaic 

modules. 

The cleaning solution, which is easily integrated 

into roll-to-roll production lines, 

makes the manufacture of any type of printed 

electronics involving laser structuring 

more economical, more productive and 

more sustainable. Another application is 

electrode production in battery manufacturing. 

The effects of deburring were demonstrated by measuring the IV curve of modules 

produced on substrates that were untreated (d), manually cleaned (e) and cleaned using 

the CO2 snow jet technology (f). b and c show the light and dark curves of the three 

differently-treated modules. In the DLIT images of the modules (d, e, f), the bright areas 

indicate hot, localized spots, which are particularly visible in the interconnection zones of 

the uncleaned modules. (Photo credit: Research project team PV-CO2) 

acp systems AG 

Berblingerstraße 8 

D 71254 Ditzingen 

Telefon: +49 7156 480140 

eMail: mail@acp-systems.com 

Internet: http://acp-systems.com 


page 5/38

Future cluster 

QSens starts the 

second round of 

funding 

View into the clean room: Quantum components are manufactured here. 

(Photo: QSens) 

In the “Cluster4Future” QSens of the Universities of Stuttgart 

and Ulm, scientists, companies and start-ups are researching 

quantum sensors with a wide range of potential applications. 

The Federal Ministry of Education and Research 

is funding QSens for a further three years as part of “Clusters4Future”. 

High-precision and powerful quantum sensors are needed in many 

areas, including medical technology, navigation systems in autonomous 

vehicles, energy storage in batteries, and intelligent production 

processes. “Among quantum technologies, quantum sensors 

are currently the furthest on the way to market maturity and offer 

great application potential that we want to tap into with QSens,” says 

Prof. Jens Anders, Cluster Spokesperson and Head of the Institute 

of Smart Sensors (IIS) at the University of Stuttgart. The researchers 

and industry partners working together in the Cluster4Future 

“Quantum Sensors of the Future” (QSens) develop the technology 

for practical use further, make it usable for autonomous technical 

systems, and transfer it from research to industrial application. 

Numerous patents and QSens research demonstrators, which were 

shown at international trade fairs such as the “Hannover Messe” 

trade fair and the Quantum Effects trade fair in Stuttgart show how 

QSens research is to the market. 

Innovation ecosystem and wide range of applications 

In the first round of funding, the participants established an “innovation 

ecosystem” of research institutes, large companies, SMEs 

and start-ups. It is intended to serve as a springboard for disruptive 

technologies and strengthen the innovative capacity of Germany. In 

the second round of funding, this ecosystem will be further strengthened 

and expanded. After addressing a broad range of topics in 

the first phase of implementation – from industrial sensors to sensors 

for (bio)medical technology to sensors for applications in space 

– the cluster will focus on sensors for biomedical technology in the 

second phase. Research will include quantum sensors to control intelligent 

prostheses and measure biomarkers for the early detection 

of diseases or per- and polyfluoroalkyl substances (PFAS). These forever 

chemicals are potentially harmful to health and occur in many 

products. 

New quantum platform for SMEs 

In order to further strengthen and expand the QSens ecosystem, an 

association that interested industrial partners can join will be founded 

in the second phase. In addition, the QSens platform Quantum 

4SME will be expanded. On the one hand, QSens will enabele partners 

without a clean room to manufacture quantum devices. On the 

other hand, it aims to provide SMEs with access to state-of-the-art 

machines and processes for the scalable and thus cost-effective integration 

of quantum devices into sensor modules. This will set the 

course for the third implementation phase in which the first QSens 

products are to reach the market and enable the cluster to be consolidated 

in the long term beyond BMBF funding. Through close 

cooperation with the Institute of Entrepreneurship and Innovation 

Science (ENI) at the University of Stuttgart, QSens is focusing even 

more on the topics of spin-offs and intellectual property. 

The Cluster4Future QSens 

The Cluster4Future “Quantum Sensors of the Future” (QSens) of 

the Universities of Stuttgart and Ulm received approximately EUR 

15 million from the Federal Ministry of Education and Research 

(BMBF) in the first round of funding from 2021 to 2024 as part of 


page 6/38

Toxicology 

EVape helps improve 

consumer safety 

in the e-cigarette 

segment 

Science meets industry: from left to right: Prof. Jens Anders 

(University of Stuttgart), Michael Förtsch (Q.ANT GmbH), 

Prof. Jörg Wrachtrup (University of Stuttgart). 

(Photo: QSens) 

the “Clusters4Future” competition. In the second round 

of funding, the BMBF will provide the cluster with up to 

an addition EUR 15 million. Under the coordination of 

the University of Stuttgart, alongside the University of 

Ulm, the University of Tübingen, three research transfer 

organizations, and 17 partners from industry and the 

biotechnology and pharmaceutical sectors are participating 

in QSens. QSens is an important cornerstone 

of a growing regional quantum ecosystem, which includes 

the Center for Integrated Quantum Science and 

Technology (IQST), the Baden-Wuerttemberg initiative 

QuantumBW, and the Stuttgart Center for Applied 

Quantum Research (ZAQuant). 

Electronic cigarettes, or vapes, are commonly viewed as 

less harmful to people’s health than tobacco cigarettes. 

And yet, they are not without health drawbacks. For many 

ingredients, it is unknown how they will behave when heated. 

Since the temperatures inside e-cigarettes vary widely, 

different products can be released during thermal decomposition. 

This makes it more difficult to gauge the potential 

risks of these tobacco alternatives. Until now, there has 

been no testing system that could be used to test the ingredients 

used across the entire relevant temperature range. 

Now, with EVape, the Fraunhofer Institute for Toxicology 

and Experimental Medicine ITEM has developed a prototype 

device for controlled vaporization of e-liquids in a broad 

temperature range. The emissions released during the process 

can then be analyzed and subjected to a toxicological 

assessment. The findings are generally valid, regardless of 

which e-cigarette the liquid is used in. 

About the Clusters4Future competition 

With the “Clusters4Future” competition, which was 

launched in 2019, the BMBF aims to strengthen knowledge 

and technology transfer, generate new added value, 

and expand the position of Germany as one of the 

world’s innovation leaders. Regional innovation clusters 

such as QSens intended to find solutions to urgent social 

challenges and promote an open innovation culture. 

The first round of competition in 2019 resulted in seven 

successful cluster outlines out of 137. Five of them, 

including QSens, will now be funded for another three 

years. In 2022, a further seven clusters were approved 

in the second round of competition. There are currently 

14 future clusters that can go through a maximum of 

three implementation phases of up to three years each. 

Funding of up to EUR 5 million per cluster per year is 

planned. 

Universität Stuttgart 

D 70174 Stuttgart 

Researchers at Fraunhofer ITEM can use the patented EVape prototype 

to vaporize e-liquids under controlled conditions in order to analyze the 

emissions generated during the process and then conduct a detailed 

toxicological assessment. © Fraunhofer ITEM, Ralf Mohr 

Vapes are increasingly popular and these days can be found in many 

different places, from supermarkets to kiosks and gas stations. There 

is a broad selection, encompassing many different models, flavors, 

and liquids. The sheer variety makes it difficult to assess the health 

risks posed by e-cigarettes in general. Under Germany’s Ordinance 

on Tobacco Products (Tabakerzeugnisverordnung, TabakerzV), the 

liquids used in electronic cigarettes must not pose a risk to human 

health when either heated or not. However, for many ingredients, it 


page 7/38

Dr. Stefanie Scheffler developed EVape in collaboration with her team at Fraunhofer ITEM. 

The portable device can help protect consumers of e-liquids from health risks. 

© Fraunhofer ITEM, Ralf Mohr 

is unknown how they will behave when heated. 

The vaporization of the liquids could 

release components that are problematic 

from a health perspective — especially if 

they contain substances that are considered 

safe when consumed orally or inhaled 

but break down into other substances with 

potentially concerning toxicological profiles 

when heated. Further study is needed for a 

number of additives and food flavorings that 

are intended to improve the taste of e-cigarettes, 

which are made mainly of glycerin, 

propylene glycol, and nicotine. “Nicotine is 

stable when exposed to high temperatures. 

It keeps its molecular structure when heated 

to 500 degrees Celsius. Other additives are 

different, though. One example is sucralose, 

a sweetener that is also used in e-liquids, 

or vape juice. Sucralose is sensitive to temperature. 

It breaks down at just 120 degrees 

Celsius and forms substances that are carcinogenic. 

That’s why more and more e-liquid 

manufacturers are eliminating it from 

their products,” says Dr. Stefanie Scheffler, 

a scientist at Fraunhofer ITEM in Hannover. 

She and her team are working to improve 

consumer safety for e-cigarettes, since 

many additives have not yet been studied 

adequately. 

EVape ensures vaporization 

under controlled conditions 

With EVape, the researchers have now developed 

a patented system that can be used 

to test e-liquids across the entire relevant 

temperature range. This was previously impossible 

but it is very important, because a 

toxicological risk assessment needs to take 

into account the fact that the temperature 

inside e-cigarettes varies widely depending 

on the model and built-in battery. As 

a result, the fission or thermal decomposition 

products produced by different e-cigarettes 

can vary as well. While manufacturers 

are required to disclose toxicology 

data for the liquids and their emissions, the 

information is generated using different 

commercially available e-cigarettes with 

diverse temperature profiles, so the results 

are not universally valid or comparable. 

With that in mind, the team set out to test 

the ingredients used across the entire relevant 

temperature range, from 150 to 350 

degrees Celsius. Right now, however, there 

is no test system that enables this extensive 

testing scenario and covers the entire temperature 

range. The researchers at Fraunhofer 

ITEM intend to close this gap with 

EVape: The portable lab device, which can 

be hooked up to standard analysis equipment, 

ensures that vaporization takes place 

under controlled conditions, so the results 

are independent of the e-cigarette used, 

making them comparable. 

Testing of various commercially available 

e-liquids at different temperatures is 

performed under real-life conditions: The 

e-liquid is vaporized suddenly while being 

exposed to normal air from the surroundings. 

Continuous real-time measurement 

of the temperature keeps the liquid from 

overheating during the tests. “We apply 

small amounts of the liquid to a hot heating 

surface, so it instantly vaporizes. Then the 

vapor is sucked off and can be analyzed to 

see what substances are in it. They can be 

compared against the substances analyzed 

from before the vaporization process to gain 

information about the thermostability of 

those substances,” says Scheffler, describing 

the testing process. Initial results show 

that the spectrum of substances found depends 

on temperature. 

Standardized checks to 

improve e-liquid quality 

EVape offers manufacturers ways to rule 

out potentially harmful substances even 

before they produce their e-liquids. It allows 

them to quickly and effectively generate 

toxicological profiles for e-liquids, 

limit them to or approve them for certain 

temperature ranges, and identify all of the 

emissions generated under realistic conditions 

through continuous real-time measurements 

of temperature. Beyond that, the 

researchers also hope EVape will help regulatory 

authorities monitor the e-cigarette 

liquids available on the market. “We plan 

to license EVape in the future and make it 

available to labs, regulatory authorities, and 

industry. Our goal is for EVape to be used as 

a reference device so e-liquids don’t reach 

the market before being tested using our 

testing system.” 

Fraunhofer-Institut für Toxikologie und 

Experimentelle Medizin ITEM 

D 30625 Hannover 


page 8/38

Material airlocks in combination with fire and radiation protection 

Material airlocks for GMP, clean rooms or safety 

areas for every building situation 

Controlled transfer between cleanrooms with GMP classification or 

for use in ISO cleanrooms, pharmaceutical production, life science 

plants, chemical areas and food industries. 

Material airlocks and trolley sluices are used for the controlled and 

safe transfer of products and materials between rooms of different 

cleanliness classes. 

Our active, partially active or passive material and trolley airlocks fulfill 

the cleanliness class according to DIN EN ISO 14644-1 ISO class 

5, in accordance with GMP guidelines and are designed for GMP 

classes A-D. In combination, additional requirements such as safety 

classes, decontamination and secure airlock access can also be met. 

Versions: 

– Material airlock 

– Trolley airlock for transferring large or heavy materials 

with a transport trolley 

– Personnel airlocks 

The cleanroom airlocks consist of a double-wall construction and 

flush-mounted door elements on both sides. They can be installed 

flush with the surface and have a hygiene-optimized, disinfectantresistant 

design made of glass and stainless steel. 

The hinged doors have large viewing windows made of safety 

glass. The doors are sealed all round and the door hinges can be adjusted 

in three dimensions. The electrical interlocking of the doors 

ensures that there is no air exchange between the rooms. 

HT Group systems are tested, certified and supplied 

with FAT documents. 

https://www.htgroup.de/en/products/health/gmp-material-sluice 

HT Group GmbH 

Rambacher Str. 2 

D 91180 Heideck 

Telefon: +49 9177 980 

eMail: info@htgroup.de 

Internet: http://www.htgroup.de 


page 9/38

Goldfuß Engineering has developed a new robot-based filling line for 

small batch sizes together with the containment expert Weiss Pharmatechnik. 

©Goldfuß Engineering GmbH 

The robot is equipped with a three-sided multi-function gripper, developed 

by Goldfuß Engineering specifically for this application. ©Goldfuß 

Engineering GmbH 

Automated containment cell with MOTOMAN HD7 for research 

and smaller laboratories 

Filling of medicines under cleanroom 

conditions with a hygienic handling 

robot 

New regulations and the shortage of skilled workers are 

making automated filling of medicines increasingly interesting 

for smaller laboratories. Goldfuß Engineering has 

developed a new system in which a hygienic handling robot 

MOTOMAN HD7 from Yaskawa fills up to 120 vials per hour 

under clean room conditions. 

For clinical trials or personalized medicine, small batch sizes of drugs 

are usually required, such as injection solutions filled into so-called 

vials. These small vials or glass jars must be sterile and aseptic. Small 

batch sizes make it uneconomical to fill them on conventional systems. 

Thomas Goldfuß, CEO of Goldfuß Engineering, is convinced 

that automation will now also be appealing for smaller laboratories 

– for two reasons: firstly, the First Air principle in the new version of 

EU-GMP Annex 1 requires that all products must be continuously 

surrounded by clean, filtered air during an aseptic process. The second 

reason is, of course, the shortage of skilled workers. 

MOTOMAN HD7: High-performance robot with hygienic design 

Goldfuß Engineering specializes in custom laboratory automation 

in clean room environments. Together with containment 

expert Weiss Pharmatechnik, the company with headquarters in 

Balingen in southern Germany has developed a robot-based filling 

line for small batch sizes. This allows small batches of up to 

120 vials per hour to be automatically filled and sealed in a class 

B laboratory room. The cell can also be flexibly adapted for other 

processes, such as cell cultivation, R&D automation or product 

and water analysis. 

The centrepiece of the system is a safety workbench from Weiss 

and an industrial robot MOTOMAN HD7 from Yaskawa (HD stands 

for „hygienic design“), which has been specially designed for the hygiene 

and clean room sector. For this purpose, Goldfuß Engineering 

has developed a multi-functional gripper with three sides, The MO- 

TOMAN HD7 picks up the individual parts of the vials, takes them 

to the filling station, closes the filled vials and transfers them to a 

magazine. Optionally, the robot and the functional units can also be 

integrated into an isolator from Weiss. 


page 10/38

Goldfuß Engineering has been working with Yaskawa robots for 16 

years now. “The features of the MOTOMAN HD7 are perfectly matched 

to our solution. For this application, the robot must meet the 

requirements of cleanroom class A (ISO 5) and the corresponding 

certificates are important for the validation of the system according 

to GMP. It is also crucial that the surfaces can be cleaned with all 

common media, and sterilization with UV light or H2O2 fumigation 

is possible,” says Thomas Goldfuß. 

The experience of Goldfuß Engineering with Yaskawa robots 

made integration and programming very easy. We opted for the Yaskawa 

model MOTOMAN HD7 because operation and programming 

are intuitively simple. With the support of Yaskawa we also had very 

good experience, for example with regard to training, rental equipment 

and tests.” 

First customer inquiries are in progress 

The new MOTOMAN HD7 meet the requirements of cleanroom class A 

(ISO 5). ©Goldfuß Engineering GmbH 

Simple operation and programming 

In June 2024, Goldfuß Engineering presented the system for the first 

time at the Achema process industry fair. Thomas Goldfuß and his 

team are already working on the first customer requests – not only 

from small laboratories: even a pharmaceutical company is considering 

the system as a backup during downtimes of its large plant for 

maintenance and service operations. 

YASKAWA Europe GmbH 

D 85391 Allershausen 

Insights on EM for 

pharmaceutical quality 

assurance at QATS Symposium 

Cherwell, cleanroom microbiology solutions 

expert, is pleased to announce its participation 

in the upcoming Pharmaceutical 

Quality Assurance and Technical Services 

(QATS) Symposium in Birmingham, 17-18 

October 2024. Cherwell’s new Microbiology 

Product Specialist, Yoggya De Silva, will 

be available on the company’s stand (stand 

number 64) to share insights on environmental 

monitoring (EM) for pharmaceutical 

manufacturing. 

Organised by the QATS Interest Group 

of the Guild of Healthcare Pharmacists, this 

symposium is an important event for professionals 

in pharmaceutical quality assurance 

and technical services, microbiology and 

pharmaceutical environmental monitoring. 

Known for detailing the latest innovations 

and regulatory updates in this sector, QATS 

will take place at the Hilton Birmingham 

Metropole, NEC, Birmingham. 

Cherwell’s newest microbiology expert 

team member, Yoggya De Silva, brings a 

wealth of experience in product management 

and microbiological solutions in sterile 

medical product, plus API and biologics 

manufacturing. She studied biochemistry 

and gained an MSc in immunology before 

working for several life science companies, 

including Lonza, Nova Biomedical and SaniSure, 

where she has built significant industry 

understanding. Yoggya is eager to 

engage with QATS attendees to share her 

expertise, and will be on hand to discuss 

Cherwell’s range of products, including its 

industry-leading Redipor® prepared media 

solutions and air samplers for EM. 

Products available to view and discuss 

on Cherwell’s stand with Yoggya and the 

team will include the new portable BAMS 

real-time, airborne microbial monitor for 

continuous air monitoring. This innovative 

product offers instant alerts to contamination 

events, making it a useful tool in high 

grade critical environments. BAMS‘ realtime 

results are also key for short shelf-life 

products requiring rapid release, such as in 

radiopharmacies. The SAS hand held microbial 

air sampler range, offering reliable 

and cost-efficient active air sampling for 

trend analyses in lower grade cleanrooms 

will be demonstrated too. 

High quality prepared culture media is 

also crucial for EM applications for regulatory 

compliance. Cherwell’s Redipor® range 

of quality-assured prepared media meets 

all needs. As well as off-the-shelf poured 

media plates, bottled media, broth bags and 

Cherwell’s new Microbiology Product 

Specialist, Yoggya De Silva, who will be at QATS 

to share insights on environmental monitoring 

for pharmaceutical QA. 

ampoules, Cherwell can produce bespoke 

Redipor formulations and packaging formats 

for specific requirements and will be 

happy to discuss in detail at QATS. 

Also on show will be Cherwell’s range of 

EM accessories. These include settle plate 

stands offering a defined sample point and 

reduced risk of spoiled samples; and plate 

carriers, for safe handling and transportation, 

as well as making efficient use of incubator 

space. SAS Daily Heads remove the 

need for a validated, sterilisation process 

and substitute this with a certificated sterile 

disposable air sampler head to reduce risk of 

false positives. 

Cherwell Laboratories Ltd 

OX26 4XB BICESTER 

United Kingdom 


page 11/38

Innovative research and development platform: wind-ing system featuring flexible 

formats and design. © Fraunhofer IPA/Rainer Bez 

First battery cell winding system of its kind 

Digitalized, Sustainable 

Battery Cell Production 

The further development and evolution of existing storage systems is a key prerequisite for the energy transition. The Center 

for Digitalized Battery Cell Manufacturing (ZDB) at the Fraunhofer Institute for Manufacturing Engineering and Automation 

IPA and acp systems AG have joined forces to commission a winding system for cylindrical battery cells featuring flexible 

formats and design. It serves as an innovative research and production platform to test new cell formats and components 

along with tab designs and also enables development of large-format cells for future battery technologies. The winding system 

is the first of its kind in the world. It is embedded in an automated, digitalized battery cell production infrastructure. 

Electric vehicle batteries consist of multiple modules, each one 

comprising many individual battery cells. These modules are the 

centerpiece of any battery and are responsible for the lion’s share of 

value creation. Cylindrical battery cells have grown more and more 

popular in the automotive industry in recent years, with the trend favoring 

large cell formats. ZDB at Fraunhofer IPA and acp systems AG 

worked together closely to develop, construct, and now commission 

a winding system for cylindrical battery cells, also known as round 

cells. It will serve as a versatile research and production platform for 

rapid testing of new cell formats and tab designs as well as advanced 

methods of enhancing quality and optimizing processes. The new 

winding system completes a production line unlike any other in Europe 

for the manufacturing of cylindrical battery cells for lithium-ion 

batteries and future battery technologies such as sodium-ion batteries. 

The special feature of the production chain is that all of the 

process steps are digitalized and interconnected, from coating and 

winding to assembly, filling, and forming. The Baden-Württemberg 

Ministry of Economic Affairs, Labour and Tourism provided funding 

for the construction and installation of the winding system. 

“At ZDB, we can cover all of the process steps involved in manufacturing 

a battery cell. The winding process is one of the core processes 

in cylindrical cell production, as the jelly roll is the centerpiece 

of the battery cell. By bringing the winding system online, we have 

closed a gap in the fully digitalized process chain, so the production 

line is complete,” says Julian Grimm, head of the research team at 

Fraunhofer IPA and Deputy Head of ZDB. 


page 12/38

Format and design flexibility for cylindrical battery cells (round cells). 

© Fraunhofer IPA 

Jelly rolls and cylindrical battery cell 

produced at Fraunhofer IPA (21700 round 

cell in tabless continuous design). 

© Fraunhofer IPA/Rainer Bez 

Data collection associated with battery cells 

Electrodes and separators rolled up into jelly rolls 

There are about a dozen work steps involved in getting a cell ready 

for use. During the winding process, the positive and negative electrodes 

are rolled up together with two separators to form a jelly roll. 

After that, the battery is assembled, a step that requires the jelly roll 

to be moved and positioned with great accuracy. A rod electrode is 

then inserted through the central hole in the roll and used to weld 

the roll to the base of the cylinder. 

But the new winding system for cylindrical battery cells is more 

than just a production platform for jelly rolls. It will also serve as a research 

platform for developing innovative cell systems and formats 

and testing their quality. “What makes our system unique is its flexibility. 

It allows us to realize different cell formats in different sizes 

and tab designs, such as tabless designs, which don’t have a tab welded 

onto them. The tab, a narrow terminal element on the anode and 

cathode that the electricity has to flow through, is the chokepoint in 

large-format cells,” Grimm says. In round cells, the trend is toward 

larger cell formats, which take up more space in terms of both diameter 

and height. This means the roll and the cell itself end up being 

larger. But the issue is that the larger the cells are, the more difficult 

it is to collect the current and dissipate heat. “We can respond to this 

challenge with individual tab designs. In a tabless design, for example, 

the carrier foil made of aluminum and copper can serve to collect 

current and dissipate heat, enabling greater conduction of both 

than a traditional tab,” Grimm explains. Innovative cell designs ensure 

homogeneity in cylindrical cells, allowing for large cell formats. 

Larger cells with more active material can be used to achieve greater 

energy density, which in turn extends the range of electric vehicles. 

To minimize waste and improve quality, the entire production process 

is digitalized and interconnected. To that end, sensors collect 

data, which is then aggregated in real time in the cloud. Traceability 

technologies developed at Fraunhofer IPA make it possible to associate 

the data collected with the battery cells produced. Each and 

every individual battery cell produced is available for data analyses 

and to train artificial intelligence. In this way, it is possible to trace 

the conditions under which the cell was produced and determine 

how they relate to the final product quality. The data is used to develop 

services with monitoring, analysis, and predictive capabilities. 

This makes it possible to improve the production process and eliminate 

sources of error faster than before. 

“Innovative cell designs require redesign and optimization of 

production processes, which we can study using the winding system. 

The combination of innovative cell design and agile approaches 

to production is the key to meeting the requirements of a rapidly 

changing energy landscape, enabling faster market launches of new 

solutions, and paving the way forward for sustainable, high-quality 

battery technologies,” Grimm says. Manufacturers and users of electrodes, 

separators, and cells can also use the system to test their prototypes, 

products, cell components, materials, and designs. 

Fraunhofer-Institut für Produktionstechnik und Automatisierung IPA 

Nobelstraße 12 

D 70569 Stuttgart 

Telefon: +49 711 970 1667 

eMail: joerg-dieter.walz@ipa.fraunhofer.de 

Internet: http://www.ipa.fraunhofer.de 


page 13/38

Figure 1: Test setup – a personnel cut-off room equipped with Spectral Blue devices. 

„Substantial and persistent reduction of microbial burden in a personnel cut-off room 

within a pharmaceutical facility following the implementation of automated and 

continuous Spectral Blue disinfection“ 

Substantial and persistent reduction 

of bioburden in a GMP certified 

pharmaceutical facility 

A leading international pharmaceutical company conducted a comprehensive 

evaluation of the automatic and continuous Spectral 

Blue disinfection system at one of their manufacturing facilities 

in the Nordics. The touch-free, UV-free, and chemical-free system 

uses patented multi-wavelength blue light technology to eradicate 

airborne and surface-dwelling microbes. 

The observed outcomes were unparalleled. The application of 

Spectral Blue in the cleanroom facility not only i) substantially diminished 

contamination but also ii) enhanced the efficacy of the existing 

cleaning and disinfection protocols. 

1. Summary of results 

– Microbial surface contamination, as measured, decreased from 

over 200 colony-forming units (CFU) per 25 cm2 to fewer than 

20 CFU per 25 cm2 throughout the testing period. 

– A distinct downward trend in microbial contamination 

was observed during the test period. 

– The reduction proved to be persistent, remaining noticeable 

even after deactivating the blue light system. A plausible 

explanation is that Spectral Blue eliminated dry biofilms in the 

room, subsequently enhancing the effectiveness of traditional 

cleaning methods. 

2. Background 

The aim of the test was to assess the potential impact of deploying 

the Spectral Blue system on measured microbial contamination. 

The evaluation took place in a frequently utilized personnel cutoff 

room, designated as class D cleanroom zone. This room is situated 

between a laboratory area (class F) and a production area (class C). 

The company conducted environmental microbial sampling in 

the room before, during, and after the test. Previous microbial surface 

samples taken in the room had exhibited occasional spikes and 

variability, prompting the quality management team to explore new 

contamination control methods. 


page 14/38

Figure 2: Measured microbial 

burden in the cut-off room 

during and after the use of 

Spectral Blue. 

3. Test setup and data collection 

The room was equipped with two Spectral Blue devices (plug & play 

series) and a Spectral Blue control module featuring a motion sensor 

and an hour calculator. The system was configured for continuous 

disinfection, allowing the control module to activate blue light disinfection 

automatically whenever the room was unoccupied. The 

operating hours were recorded on a weekly basis. 

For the microbial surface sampling employed as the test method, 

the company utilized the same approach as part of their regular 

contamination control practices, with only the sampling frequency 

increased. Samples were collected and analyzed by the company‘s 

own laboratory. 

Over a period of 10 weeks September-November 2023 (excluding 

weekends), microbial surface samples were taken from the floor 

using 25 cm2 contact plates: In total 6 weeks with blue light on and 

afterwards 4 weeks with blue light off. The chosen sampling site remained 

consistent throughout the entire test period. 

Throughout the test, the company kept its standard mechanical 

cleaning and chemical disinfection processes unchanged. The personnel 

cut-off room continued its normal usage, with a comparable 

level of foot traffic as during other times. This approach allowed any 

observable reduction in microbe levels to be attributed specifically 

to the blue light disinfection. 

4. Results 

Within two weeks („active phase“), there was a substantial reduction 

in measured colony-forming unit (CFU) counts, decreasing from 

over 200 CFU per 25 cm2 to fewer than 20 CFU per 25 cm2, displaying 

a distinct downward trend in daily sampling. The same trend also 

continued for the subsequent 4 weeks with weekly sampling („routine 

phase“) while blue light was in use (see figure 2). 

The newly attained CFU levels now fall well below the company‘s 

alert threshold. Once reaching these lower levels, they consistently 

remained very low and continued to improve gradually. 

These results affirm that continuous disinfection provided by 

Spectral Blue effectively diminishes contamination, even within 

ultra-clean environments. The system proves effective against microbes 

that are challenging to eliminate using traditional methods. 

Drawing from other research in the field, a significant portion of 

contamination identified in cleanrooms can be traced back to personnel 

cut-off rooms and gowning rooms. The application of Spectral 

Blue in these areas serves as an effective preventive measure 

against the risk of contamination entering production areas. 

5. Persistent effect attributable to elimination of dry biofilms 

An additional noteworthy discovery in the test was that, even after 

deactivating the test system, microbial contamination levels remained 

remarkably low in subsequent measurements taken weekly for 4 

weeks („follow-up phase“). 

This persistent effect can be plausibly credited to Spectral Blue‘s 

capability to eliminate biofilms from the surfaces in the room. In this 

case, the biofilms in question can have been so called dry biofilms, 

that can form for example around chemical residues. 

Eliminating the biofilms then enabled the standard cleaning and 

disinfection practices, which are generally less effective against biofilm, 

to demonstrate improved performance, maintaining the room 

at a consistently high level of hygiene. 

6. Further remarks and discussion 

The results observed in the test suggest the potential for cleanroom 

operators to reduce reliance on hazardous chemical disinfectants, 

thanks to automatic Spectral Blue disinfection. 

An enhanced contamination control process would involve 

cleaning surfaces with a detergent and continuously disinfecting 

using multi-wavelength blue light. 

An often-overlooked aspect of chemical usage is the tendency to 

leave residues on surfaces, creating a growth platform for microorganisms 

(forming a so-called dry biofilm). When fewer chemicals are 

used, the impact of dry biofilm becomes less problematic. 

Reducing chemical usage not only addresses concerns related to 

dry biofilm but also enhances the health and safety of the workplace. 

Chemical vapors are known to be associated with long-term health 

issues among cleaning and disinfection personnel. 

Additionally, the adoption of this approach contributes to the 

environmental friendliness and sustainability of manufacturing 

operations by eliminating chemicals from processes. This step aligns 

with companies‘ efforts to meet stringent ESG targets. 

SPECTRAL BLUE 

D 59558 Lippstadt 


page 15/38

The ARCTIC-Consortium. © imec 

Fraunhofer IPMS and IAF collaborate with 34 European partners in project ARCTIC 

EU-project joins forces towards the era 

of scalable control technology for quantum 

processors 

In order to make quantum computers usable, 

developing the control technology is 

at least as important for scaled systems, 

yet it is still in its infancy. Project ARCTIC 

brings together 36 international partners 

from industry, academia and leading RTOs 

to establish a complete and comprehensive 

European supply chain and develop scalable, 

reliable, innovative control infrastructure 

for cryogenic quantum processors. The 

German Institutes Fraunhofer IPMS and 

Fraunhofer IAF contribute their extensive 

expertise in device characterization. The EU is funding the 

project with over € 11 million for a duration of three years. 

Quantum computing is currently seen as the most promising contender 

to efficiently solve problems which are completely out of 

reach for classical computers. Such a computer requires an enormous 

amount of control technology and interfacing to function. For 

quantum computers based on qubits operated close to absolute zero 

Kelvin inside a cryostat, the number of possible signal lines fed from 

the machinery into the cryostat is currently limited due to restricted 

space, heat exchange through the wires and 

the signal integrity due to long wires. 

“The performance requirements asked of 

electronic devices and circuits at cryogenic 

temperatures are quite different compared to 

those at room temperature. Especially when 

interfacing very sensitive applications such 

as quantum processors, all aspects of microelectronic 

technologies need to be optimized,” 

says Alexander Grill, scientific leader of ARC- 

TIC (“Advanced Cryogenic Technologies for 

Innovative Computing”) at Belgian research center imec. The expected 

project outcomes are considered as important enablers for 

highly demanded technologies that can resolve existing problems in 

areas such as computational chemistry, bio and life sciences, cryptography 

needed for data protection and cyber security. 

ARCTIC brings together 36 partners from industry, academia 

and leading RTOs to establish a complete and comprehensive European 

supply chain for cryogenic photonics, microelectronics, and 

cryo-microsystems around the emerging quantum computing industry 

and different cryo-enabled ICT applications. 

Fraunhofer is involved in ARCTIC with its Institutes for Photonic 


page 16/38

Setup for RF-characterization under 

cryogenic conditions. 

© Fraunhofer IPMS 

Microsystems IPMS and for Applied Solid State Physics IAF. Their 

focus within the project lies on the characterization of semiconducting 

devices in cryogenic environments and peripheral devices for 

cryogenic quantum computing processors on full wafers as well as 

the analysis of the electrical behavior of transistors and memory devices 

at untypically low temperatures. 

Fraunhofer IAF characterizes peripheral devices 

for cryogenic quantum processors 

Device characterization is as crucial as it is time-consuming, especially 

when it comes to cryogenic measurements and characterization 

with long cool-down and warm-up times. Fraunhofer IAF takes an 

essential role in ARCTIC by providing characterization capabilities 

of peripheral devices for cryogenic quantum processors on commercially 

sized wafers with an automated cryogenic full-wafer prober. 

Alongside its extensive knowledge in characterization methodologies 

for semiconductor device for R&D purposes up to industrial 

tests of 200 mm and 300 mm wafers, Fraunhofer IAF is one of the 

very few European providers of such low temperatures test set-up 

below 2 Kelvin. This profound knowledge about cryogenic device 

characterization and statistical variability of key technologies will 

be integral to ARCTIC and help accelerate the industrial testing of 

cryogenic technologies necessary to scale up quantum computing. 

The project at Fraunhofer IAF is financed by the EU (Horizon 

Europe) and co-financed by the German Federal Ministry of Education 

and Research (BMBF). 

Fraunhofer IPMS will contribute competencies in 

characterization of commercial semiconductor devices 

The cryogenic on-wafer prober at Fraunhofer IAF enables fully automatic 

characterizations of up to 25 whole 200-mm or 300-mm wafers with 

devices for quantum computing and sensing. © Fraunhofer IAF 

The Center Nanoelectronic Technologies (CNT) at Fraunhofer 

IPMS focuses on the characterization and modelling of bipolar and 

CMOS-transistors as well as memory elements at cryogenic temperatures. 

The emphasis will be put on high frequency, noise and 

defect characterization and modelling of commercial transistors in 

22FDX FDSOI technology as well as the development of optimized 

non-volatile ferroelectric memories. For this, it is crucial to improve 

characterization methods in cryogenic environments and on full 

wafers and to generate a deep understanding of how field-effect 

transistors and memory devices behave at untypically low temperatures. 

“We want to gain new insights into the energetic position 

and number of electrical defects in the transistors. This will allow the 

industry to offer new cryo-designated products and Fraunhofer to 

offer unique characterization methodologies for these products. The 

reduction of defect induced noise in electronics is an important factor 

for increasing the coherence time of qubit states, that is why the 

developed methodologies are directly relevant for cryogenic quantum 

computing approaches. Regarding the non-volatile memories it 

is furthermore important to minimize the power consumption of the 

devices, since the cooling power is very limited inside of cryostats” 

explains Dr. Maik Simon, researcher within the Quantum Technologies 

group at the CNT in Dresden, Germany. 

Another demonstration of Fraunhofer IPMS’s competences is 

investigating the applicability of non-volatile ferroelectric three-terminal 

memories for a cryogenic environment by electrical characterization 

and physical modelling. This pioneering study will reveal 

how the devices perform at low temperatures and what parameters 

can be altered to enhance switching characteristics, integration density 

and reliability. 

The project at Fraunhofer IPMS is co-financed by the German 

Federal Ministry of Education and Research (BMBF) and the Saxon 

State Ministry for Economic Affairs, Labour and Transport (SMWA). 

About ARCTIC 

ARCTIC brings together technology developers, technology integrators, 

modelers, designers, system/application players and end users 

to ensure a smooth interfacing between respective layers. At the 

same time, we focus a large fraction of the effort on missing links – 

among others in the cryo-modelling and standardization space. In 

addition, we strongly leverage the unique R&D ecosystem in Europe, 

with RTOs collaborating and forming the bridge between the academic 

innovation models and the industrial valorization – the latter 

both at SMEs and large industrial companies at once. 

Fraunhofer-Institut für Angewandte Festkörperphysik IAF 

D 79108 Freiburg 


page 17/38

The different color nuances of the AlYN/GaN wafers result from different yttrium concentrations and growth conditions. © Fraunhofer IAF 

Milestone in semiconductor development 

New semiconductor material: 

AlYN promises more energy-efficient 

and powerful electronics 

Researchers at Fraunhofer IAF have made a breakthrough 

in the field of semiconductor materials: With aluminum yttrium 

nitride (AlYN), they have succeeded in fabricating and 

characterizing a new and promising semiconductor material 

using the MOCVD process. Due to its excellent material 

properties and its adaptability to gallium nitride (GaN), 

AlYN has enormous potential for use in energy-efficient 

high-frequency and high-performance electronics for information 

and communications technology. 

Aluminum Yttrium Nitride (AlYN) has attracted the interest of many 

research groups around the world due to its outstanding material 

properties. However, the growth of the material has been a major 

challenge. Until now, AlYN could only be deposited by magnetron 

sputtering. Researchers at the Fraunhofer Institute for Applied Solid 

State Physics IAF have now succeeded in fabricating the new material 

using metal-organic chemical vapor deposition (MOCVD) technology, 

thus enabling the development of new, diverse applications. 

“Our research represents a milestone in the development of new 

semiconductor structures. AlYN is a material that enables increased 

performance while minimizing energy consumption, paving the way 

for innovations in electronics that our digitally connected society 

and its ever-increasing technology demands urgently need,” says 

Dr. Stefano Leone, scientist at Fraunhofer IAF in the field of epitaxy. 

With its promising material properties, AlYN could become a key 

material for future technological innovations. 

Recent research had already demonstrated the material properties 

of AlYN, such as ferroelectricity. In developing the new compound 

semiconductor, the researchers at Fraunhofer IAF focused 

primarily on its adaptability to gallium nitride (GaN): The lattice 

structure of AlYN can be optimally adapted to GaN and the AlYN/ 

GaN heterostructure promises significant advantages for the development 

of future-oriented electronics. 


page 18/38

Researchers at Fraunhofer IAF have succeeded in 

growing AlYN/GaN heterostructures in a MOCVD reactor 

on 4-inch SiC substrates. © Fraunhofer IAF 

With their work on the epitaxy and characterization 

of AlYN/GaN heterostructures, the Fraunhofer IAF research team 

achieved a breakthrough in the field of semiconductor materials. 

© Fraunhofer IAF 

From layer to heterostructure 

In 2023, the Fraunhofer IAF research group achieved groundbreaking 

results when it succeeded in depositing a 600 nm thick AlYN 

layer for the first time. The layer with wurtzite structure contained 

an unprecedented yttrium concentration of more than 30 percent. 

Now the researchers have achieved another breakthrough: they have 

fabricated AlYN/GaN heterostructures with a precisely adjustable 

yttrium concentration, which are characterized by excellent structural 

quality and electrical properties. The novel heterostructures have 

an yttrium concentration of up to 16 percent. The structural analysis 

group, led by Dr. Lutz Kirste, continues to perform detailed analyses 

to further the understanding of the structural and chemical properties 

of AlYN. 

The Fraunhofer researchers have already measured very promising 

electrical properties of AlYN that are of interest for use in electronic 

components. “We were able to observe impressive values for 

sheet resistance, electron density and electron mobility. These results 

showed us the potential of AlYN for high-frequency and highperformance 

electronics,” Leone reports. 

AlYN/GaN heterostructures for high-frequency applications 

Due to its wurtzite crystal structure, AlYN can be adapted very well to 

the wurtzite structure of gallium nitride with a suitable composition. 

An AlYN/GaN heterostructure promises to enable the development 

of semiconductor components with improved performance and reliability. 

In addition, AlYN has the ability to induce a two-dimensional 

electron gas (2DEG) in heterostructures. Recent research results 

from Fraunhofer IAF show optimal 2DEG properties in AlYN/GaN 

heterostructures at an yttrium concentration of about 8 percent. 

The material characterization results also show that AlYN can be 

used in high electron mobility transistors (HEMTs). The researchers 

observed a significant increase in electron mobility at low temperatures 

(more than 3000 cm2/Vs at 7 K). The team has already made 

significant progress in demonstrating the epitaxial heterostructure 

required for fabrication, and continues to explore the new semiconductor 

for the development of HEMTs. 

The researchers are also optimistic about industrial applications: 

Using AlYN/GaN heterostructures grown on 4-inch SiC substrates, 

they demonstrated the scalability and structural uniformity of the 

heterostructures. The successful creation of AlYN layers in a commercial 

MOCVD reactor enables scaling up to larger substrates in 

larger MOCVD reactors. This method is considered the most productive 

for the fabrication of large-area semiconductor structures 

and underlines the potential of AlYN for the mass production of semiconductor 

devices. 

Development of non-volatile memories 

Due to its ferroelectric properties, AlYN is highly suitable for the development 

of non-volatile memory applications. Another important 

advantage is that the material has no limitation on layer thickness. 

Therefore, the research team at Fraunhofer IAF encourages further 

research into the properties of AlYN layers for non-volatile memories, 

as AlYN-based memories can drive sustainable and energy-efficient 

data storage solutions. This is particularly relevant for data 

centers, which have to cope with the exponential growth in computing 

capacity for artificial intelligence and have significantly higher 

energy consumption. 

The challenge of oxidation 

A major obstacle to the industrial use of AlYN is its susceptibility 

to oxidation, which affects its suitability for certain electronic applications. 

“In the future, it will be important to explore strategies 

to reduce or overcome oxidation. The development of high-purity 

precursors, the use of protective coatings, or innovative manufacturing 

techniques could contribute to this. The susceptibility of AlYN 

to oxidation is a major research challenge to ensure that research 

efforts are focused on areas with the greatest chance of success,” 

concludes Leone. 

Fraunhofer-Institut für Angewandte 

Festkörperphysik IAF 

D 79108 Freiburg 


page 19/38

Free State of Saxony Supports New 

Semiconductor Test and Reliability Center 

in Chemnitz with European Union Funds 

The Fraunhofer Institute for Electronic Nano Systems ENAS in Chemnitz will receive 9.51 million euros from the European 

Regional Development Fund (ERDF) and the „Just Transition Fund“ (JTF) for the establishment of a modern competence 

center for the testing and reliability evaluation of semiconductor product. 

From left to right: Sebastian Gemkow (left, Saxon State Minister for 

Science, Culture, and Tourism), Prof. Dr. Harald Kuhn (Director, Fraunhofer 

Institute for Electronic Nano Systems ENAS), and Thomas Schmidt 

(Saxon State Minister for Regional Development) © Fraunhofer ENAS 

The Fraunhofer Institute for Electronic Nano Systems ENAS in 

Chemnitz has reached an important milestone. The Saxon State Minister 

for Science, Culture and Tourism, Sebastian Gemkow, today 

presented Prof. Dr. Harald Kuhn, Director of the Fraunhofer ENAS, 

in the presence of the Saxon State Minister for Regional Development, 

Thomas Schmidt, the two approval documents for the new 

competence center, which will advance the testing and reliability 

evaluation of semiconductors. The investment is supported with 

9.51 million euros from the European Regional Development Fund 

(ERDF) and the Just Transition Fund (JTF). The funds will make an 

important contribution to increasing the economic attractiveness of 

Saxony as a business location and to securing European independence 

in semiconductor production. 

The „Test and Reliability Center“ (TRC) will cover research and 

development in the field of testing and reliability assessment of semiconductor 

devices as a strategic activity of the European Union. 

This is particularly important as the latest semiconductor chips and 

systems are becoming increasingly complex and therefore require 

new and innovative test and reliability methods. In addition, test and 

reliability data have become an important source for further optimization 

of semiconductor production. 

„In addition, the capacity for semiconductor testing in Europe 

is limited; service providers are mostly located in Asia. Our new test 

center in Chemnitz, near the region‘s semiconductor manufacturers, 

bundles important test and reliability expertise, trains tomorrow‘s 

specialists and enables regional test and reliability service 

providers to locate here. This will cover the entire value chain in 

Saxony and Europe and provide it with sustainable support in the 

form of research, well-trained scientists and skilled workers,“ says 

Prof. Harald Kuhn. 

Science Minister Sebastian Gemkow said: „With the TRC, Europe is 

taking its test capacities for domestic chip research and industry to a 

new level. Important development steps towards the next generation 

of chips can be taken here in Saxony. Fraunhofer ENAS works at the 

interface between basic research and industry-oriented application 

research. In combination with the training of specialists at Chemnitz 

University of Technology, an important link in Saxony‘s semiconductor 

value chain is being strengthened.” 

As Saxony‘s representative in the European Committee of the 

Regions, Minister of State Thomas Schmidt has been following the 

semiconductor issue in Brussels for years: „As the Committee of the 

Regions‘ rapporteur on the European chip law, I have been closely 

involved in the discussion. The aim is to make Europe less dependent 

on semiconductor production in Asia or North America. This 

includes not only new chip factories, but also the entire chain from 

development to production and, of course, quality assurance. I am 

therefore very pleased that this funding will strengthen an area that 

has been underrepresented up to now and will now further increase 

the attractiveness of Silicon Saxony as the largest semiconductor 

cluster in Europe. I am sure that Fraunhofer ENAS will be able to 

make a significant contribution to this.” 

The Fraunhofer ENAS in Chemnitz has many years of experience 

in thermo-mechanical reliability testing of electronic systems. 

Together with the Chemnitz University of Technology as a project 

partner, the institute is now starting to build up the new „Test and 

Reliability Center“. Together, the expertise in the field of test and reliability 

at module, chip and wafer level will be gradually built up and 

expanded for research and development purposes. 

The next step is to develop test and inspection methods for 

demonstrators, pilots and low-volume production and make them 

available to companies at a low threshold. The TRC will focus on 

testing in the areas of high-performance electronics, photonics and 

quantum technologies, as well as sensors and actuators, magnetostriction 

and the development of a test data infrastructure. The TRC is 

aimed at test equipment manufacturers, semiconductor companies, 

and innovative small and medium-sized companies in the semiconductor 

industry, which will gain access to experimental test capabilities 

through the TRC. 

In parallel, the TRC will continue to research new test methods. 

The TRC will thus close the European gap in the competence area of 

testing and reliability evaluation of semiconductor components. In 

addition to research and transfer activities, the TRC will also contribute 

to the training of specialists. The new course „Design and Test 

for Integrated Circuits“ will start in October 2024 at the Chemnitz 

University of Technology to train the urgently needed junior staff for 

the semiconductor industry. 

Fraunhofer-Institut für Elektronische Nanosysteme ENAS 

D 09126 Chemnitz 


page 20/38

The MHH is one of the first institutions in Germany to be allowed to perform a new 

innovative treatment for hemophilia A and B. 

Using gene therapy to combat hemophilia 

Cell and gene therapies are on the rise. This is a new ray of hope 

for people with previously untreatable or hardly treatable diseases. 

Another novel therapeutic method is now being added: gene therapy 

for hemophilia. The Hemophilia Center at the Hannover Medical 

School (MHH) is one of the first in Germany to be allowed to perform 

this gene therapy for hemophilia A and B. In the future, it will 

not only treat its own patients, but also those affected at other hemophilia 

centers in Lower Saxony. A special collaboration between 

the centers is planned – patients will receive the gene therapy in the 

form of an infusion at the MHH, while the pre- and post-operative 

care and long-term care will be provided jointly in close consultation. 

A clotting factor is missing 

Hemophilia is a genetic blood-clotting disorder. Sufferers lack a clotting 

factor, a protein produced in the liver. The best-known forms 

of hemophilia are hemophilia A and B. In the first, clotting factor 

VIII is missing; in the second, clotting factor IX. In Germany, about 

6,000 people are affected by the disease. Due to the lack of a protein, 

their blood does not clot or only clots slowly. The tendency to bleed 

is increased, bleeding takes longer, bruises become larger and occur 

more frequently. „In severe forms, patients suffer from spontaneous 

bleeding into the large joints such as the knee, elbow or ankle from 

childhood on. In the long term, this leads to the destruction of the 

joints at a young age,“ explains Prof. Dr. Andreas Tiede, Professor of 

Hemostaseology and Head of the Hemophilia Center. In addition, 

people with severe hemophilia are at high risk for cerebral hemorrhage. 

Those affected must inject themselves with medication 

At the Hemophilia Center at the MHH, around 150 patients with severe 

coagulation disorders receive long-term care. Until now, those 

affected have had to inject the missing coagulation factor proteins 

themselves several times a week – something that most of them learn 

to do in childhood. However, the coagulation factor in the blood 

cannot be kept at a constant level through the administration of medication, 

because the half-life is short. That is why injections are necessary 

on a regular basis, even when traveling and in every situation 

in life. Not everyone succeeds in doing this. 

Just one infusion 

Gene therapy now offers those affected the prospect of an improvement. 

The therapeutic agent is administered as a single intravenous 

injection. The gene for coagulation factor VIII or IX then enters 

the liver cells using a virus shuttle. It remains in the cell nucleus as 

an episome, which is a small DNA ring, and produces the missing 

protein there. The success in patients varies. „In the studies, many 

patients almost achieved normal coagulation and were able to stop 

Special hygiene conditions: the drug for gene therapy is produced in a 

so-called clean room. (Copyright: Anna Junge/medjunge.de) 

their previous therapy. However, it is not yet possible to predict for 

an individual patient what factor level they will achieve and how long 

the success will last in each individual case,“ explains Professor Tiede. 

He admits that gene therapy is not suitable for all patients. „Some 

have antibodies against the virus that is used as a ferry. Unfortunately, 

we cannot offer the therapy to them.“ In the case of people with 

liver disease, the MHH Clinic for Gastroenterology, Hepatology, Infectiology 

and Endocrinology is consulted on a case-by-case basis 

to determine whether the patient is suitable. Despite the limitations, 

Professor Tiede considers gene therapy to be a major step forward: 

„We can measure the effect of the therapy at any time using simple 

laboratory methods based on blood samples, and thus advise the patient. 

These are very good conditions for individual care and also for 

the further development of gene therapy.“ 

Certificate according to ATMP guidelines 

Gene therapy for hemophilia falls under the guidelines of Advanced 

Therapy Medical Products (ATMP). With these guidelines, the Joint 

Federal Committee (G-BA) regulates the quality requirements for 

the preparation, implementation and follow-up of gene therapies. 

Only facilities that meet these requirements are allowed to provide 

services as part of an ATMP therapy, so that proper, safe and highquality 

care is guaranteed. The Haemophilia Centre of the MHH and 

its partner centres have been certified by the G-BA for gene therapy 

for haemophilia. 

Medizinische Hochschule Hannover (MHH) 

D 30625 Hannover 


page 21/38

Tablet stamp coated with a SICON® DLC anti-adhesive coating for the release-agent-free production 

of effervescent tablets: Prevention of adhesion of the pressed material and wear protection. 

© Fraunhofer IST, Rainer and Natalie Meier 

Surface technology and 

pharmaceutical process 

engineering – What is the 

Fraunhofer IST working on 

in collaboration with the PVZ 

at the TU Braunschweig? 

In pharmaceutical production, the interaction 

of particles with surfaces plays a decisive 

role. Whether these particles – either 

in the form of active ingredients or granules 

– adhere or are easily detached depends 

on the properties of the surfaces involved. 

Depending on the product and process, 

the specific requirements for the production 

and subsequent application of various 

medicinal products can vary: For example, 

strong adhesion can be important in the 

formulation of stable dosage forms, whereas 

in other cases the prevention of deposits is 

crucial in order to avoid expensive cleaning 

steps. 

Today we are talking to Dr. Kristina Lachmann, 

Head of Medical Technology and 

Pharmaceutical Systems at the Fraunhofer 

IST, and Dr. Jan Henrik Finke, a staff member 

at the Fraunhofer IST and Head of the 

“Pharmaceutical and Bioparticle Technology” 

department of the Institute for Particle 

Technology iPAT at the Center of Pharmaceutical 

Engineering (PVZ) at the TU 

Braunschweig, regarding the application of 

surface technologies in pharmaceutical production. 

With the help of examples, they will 

provide us with insights into how manufacturing 

processes can be optimized by means 

of innovative coatings. 

Dear Kristina, dear Jan, in which areas 

of the production process for medicinal 

products does surface technology 

play a role? 

Kristina: Surface technology is important in 

almost all steps of medicinal-product manufacture 

– from the synthesis of the active 

agent, through the production of the dosage 

form, and on to packaging and the patients’ 

use of the product. This means that the interaction 

of pharmaceutical particles with 

surfaces – with which they inevitably come 

into contact during their synthesis, formulation 

or utilization – must be precisely characterized 

and adjusted by means of surface 

technology. At the Fraunhofer IST, we are 

working with our partners on all the aforementioned 

points of the process chain and 

can offer comprehensive services in this 

regard: from consultancy, through characterization, 

on to coating development, and 

testing in industry-relevant processes at the 

PVZ. One example is tableting processes: In 

the field of coatings for tablet presses, we 

have acquired extensive experience through 

many years of cooperation with the pharmaceutical 

industry. 

Surface technology can therefore be 

used to adjust the adhesion properties. 

Can you explain this to us in more detail 

using the example of tablet presses? 

Jan: For the production of tablets, the active 

ingredient is usually initially available as 

a powder and must be pressed into shape 

using tablet presses, for example. It is thereby 

particularly important that “sticking” 

(an undesired adhesion of the powder to the 

punches of the press) does not occur, as this 


page 22/38

leads to machine downtimes, higher cleaning 

costs and losses in product yield. Additionally 

– and substantially more critical 

for the patient – is, however, the fact that the 

dosage may no longer be correct. In particular, 

new active ingredients often present a 

special challenge when it comes to establishing 

the correct dosage in the end product, 

i.e. in the tablet. A team from the Fraunhofer 

IST is currently working on enhancing the 

scientific understanding of particle-surface 

interaction. The aim is to offer customized 

surface coatings for the presses with which 

the interaction forces can be specifically 

controlled in order to directly improve the 

efficiency and stability of the production 

processes. 

In addition to the control of the adhesion, 

which is controlled by the physicochemical 

properties of the coating, further 

surface properties – e.g., a certain wear resistance 

– are often required depending on 

the product and process. These can also be 

specifically adjusted by means of the coating 

systems, technologies and expertise 

available at the Fraunhofer IST. 

The project for controlling adhesion in 

the tableting process is an example of 

the cooperation between the Fraunhofer 

IST and the Center of Pharmaceutical 

Engineering (PVZ) at the TU Braunschweig 

– but who actually does what? 

Example of a tablet stamp with removable tip. 

© Fraunhofer IST 

Kristina: At the Fraunhofer IST, we have acquired 

extensive expertise in the deposition 

of thin wear-resistant coatings and have 

been working with various manufacturers 

from the pharmaceutical industry for many 

years. The cooperation with the PVZ enables 

us to examine our coatings within an 

industry-relevant infrastructure and to systematically 

develop them further, in order 

to be able to offer the best solution for the 

respective application. At the Fraunhofer 

IST, we concentrate on the coatings, further 

developing existing coating systems, or utilizing 

completely new material systems. We 

thereby also focus on the industrial feasibility 

of the process and on the characterization 

of the coating properties – both in dependence 

on the process conditions of the coating 

deposition and also for the application 

within the pharmaceutical process chain. 

Jan: At the Center of Pharmaceutical 

Engineering, we have – as the name directly 

suggests – the infrastructure and the knowledge 

required to analyze pharmaceutical 

processes such as the production of active 

ingredients and dosage forms. Our collaboration 

with the Fraunhofer IST perfectly 

complements this, as we are able to test 

coated surfaces under real production conditions. 

This results in an intense interaction 

between materials science and process 

development, which offers new, practical 

solutions for industry. 

What results have you already achieved? 

Jan: Our knowledge regarding adhesion 

control in the tableting process can be 

transferred to other processes. We are currently 

also working with industry partners 

on the milling of active ingredient particles 

and technologies for capsule filling. In a further 

project on inhalation therapy, we were 

able to demonstrate that our coatings reduce 

the particle deposition on the surface of 

the inhalers by up to 80 %. This significantly 

increases the utilization safety of the medical 

products and the effective use of the 

active ingredient dosages. 

What do you hope for as regards 

the successful continuation of the 

collaboration? 

Kristina: We have lots more ideas for future 

projects or topics that we want to explore 

and improve with the help of surface 

technology. From a strategic perspective, it 

is important for us that the knowledge we 

have gained through fundamental research 

is transferred into relevant solutions for the 

application. The TU Braunschweig is an important 

strategic partner in this endeavor. 

In the process steps mentioned so far, 

primarily tools from the process chain are 

being modified. The coatings can, however, 

be applied just as effectively and directly 

to a wide variety of medical products, for 

example to the aforementioned inhalers 

Functionalization of active ingredients and 

excipients by means of plasma processes for 

the optimized production of individualized 

pharmaceutical products. 

© Fraunhofer IST, Falko Oldenburg 

made from plastics. Again, the interactions 

between the medication and the surface 

must be adapted to one another in such a 

way that losses during administration by the 

patient can be avoided. 

A further field of research is the investigation 

of interactions with the packaging or 

a possible modification of the pharmaceutical 

particles themselves. In the current joint 

project “RNApp”, which is being funded by 

the State of Lower Saxony, the Fraunhofer 

IST is therefore investigating the interactions 

of mRNA-containing lipid nanoparticles 

with the packaging. The aim is to reduce 

these interactions in order to increase 

the storage stability. The project offers us 

the possibility of expanding our cooperation 

with the TU Braunschweig and, furthermore, 

of opening up a further field of research 

that perfectly complements the expertise of 

the PVZ. 

Jan: One topic that has not yet been 

discussed is the 3D printing of medicinal 

dosage forms. Our aim here is to combine 

the expertise of two institutes: As regards 

the Institute for Particle Technology iPAT 

at the TU Braunschweig, this means the 

field of manufacturing and characterizing 

active-ingredient-containing intermediates 

– in this case filaments – as well as release 

control in dosage forms, and for the Fraunhofer 

IST, the field of improving adhesion in 

material combinations and the introduction 

of functional layers for release control. This 

is a further exciting perspective for future 

projects. 

Fraunhofer-Institut für Schicht- und 

Oberflächentechnik IST 

D 38108 Braunschweig 


page 23/38

Production of fine chemicals such as those used in pharmaceuticals 

is typically complex and laborious. An interdisciplinary 

team of Fraunhofer researchers worked together 

across different projects to devise a method modeled on a 

cascade, in which multiple successive stages of synthesis 

proceed without interruption. This is made possible through 

the use of novel catalysts in specially adjusted flow-through 

reactors. The new method makes the process of manufacturing 

drugs more efficient and conserves energy. In this way, 

the modular technology platform supports the production 

of pharmaceuticals in Germany as an industrial location. 

The catalysts required for synthesis are immobilized on transparent films 

(top) or used as catalyst particles (bottom). The electron micrograph 

shows a section of a particle with the carrier particles for enzymes and 

photocatalysts. Their size is in the nanometer range. 

© Fraunhofer IGB (Top) / Fraunhofer ISC (Bottom) 

Synthesizing fine chemicals 

Technological 

Advance in 

Production of 

Pharmaceuticals 

Fine chemicals are viewed in the chemical industry as very high-value 

products. They are required wherever large quantities are less of 

a concern than precision effects and high purity levels, such as in 

the production of pharmaceuticals. Manufacturing fine chemicals 

is complex and typically requires multiple successive reaction steps. 

The methods used to synthesize them have been established for 

many years, but they have also largely reached their limits in technical 

terms. 

Fraunhofer researchers have now developed an innovative synthesis 

process for manufacturing fine chemicals as part of two shared 

projects. While conventional methods rely on a sequence of different 

reactors and stirrer tanks, in which the product solution must 

be prepared and moved to a different vessel after every reaction for 

the next step, the new method involves creating the final product in 

a continuous synthesis cascade, ideally within a single reactor. This 

method significantly enhances process efficiency and makes production 

more sustainable by shortening retooling times and reducing 

the amount of energy needed. These benefits directly affect the 

carbon emissions from the synthesis process, along with its costs. 

Four Fraunhofer institutes teamed up to achieve this: the Fraunhofer 

Institutes for Molecular Biology and Applied Ecology IME, for 

Silicate Research ISC, for Interfacial Engineering and Biotechnology 

IGB, and for Microengineering and Microsystems IMM. 

Catalysis using enzymes and light 

The process devised by the Fraunhofer researchers is based on an 

innovative combination of two catalysis methods. Photocatalysts, 

which are activated with light, are combined with enzymes, which 

also act as catalysts. The enzymes are either applied to transparent 

films, which immobilizes them, or used as particles in the reaction 

medium. Project manager Dr. Michaela Müller from Fraunhofer IGB 

explains the new method’s advantages: “This way, we keep the catalysts 

from floating around freely in the solution, which requires them 

to be filtered out or removed after every step in a time-consuming 

and laborious process. The immobilized enzymes or catalysts can 

stay in the reactor while the reaction product continuously forms. If 

the enzymes become inactive, they are easy to replace without having 

to interrupt the process.” 

“The light-driven catalysis for the cascade reactions doesn’t require 

particularly high temperatures, so it is highly compatible with 

biocatalysis and also conserves energy as a result,” explains Dr. Thomas 

Rehm, the project manager at Fraunhofer IMM who specializes 

in sustainable synthesis in flow-through reactors. For maximum effectiveness 

in bringing the light into contact with the photocatalyst 

and the reaction solution, the flow-through reactors used are equipped 

with films or with thin, transparent plastic tubes known as capillaries. 

The input solution is either pumped through the reactor’s 

capillaries — including the catalyst particles and a gas to improve 

sediment transport — or fed in via the transparent polymer film used 


page 24/38

Feathers contain keratin, a water-insoluble structural protein from which components of adhesives can be produced. © Getty Images 

The joint projects developed a new technology platform for production of fine chemicals. © Fraunhofer IMM 

to carry the photocatalysts and enzymes. 

Because the cascade reaction uses enzymes, the new method is 

especially well suited to manufacturing the “chiral” fine chemicals 

frequently used in pharmaceuticals. These chemical compounds are 

based on molecules that have an exact mirror-image structure but 

cannot be superposed on each other through rotation, much like human 

hands. This is known as stereoisomerism. The chiral molecule 

can have completely different effects depending on the version, or 

isomer — the left or right hand, in this analogy. For this reason, deliberately 

producing only one isomer with as high a level of purity as 

possible is important in order to achieve maximum positive effect. 

Technological advance in chemical production 

To realize the novel catalytic method, the four Fraunhofer Institutes 

combined their respective research expertise and worked together in 

an interdisciplinary approach. This resulted in much more than just 

a new method: The Fraunhofer experts have developed a modular 

technology platform for producing various classes of fine chemicals. 

This means feasibility studies can be conducted for industry customers 

to tailor their desired processes to the individual reactions and 

catalytic combinations involved. 

The pharmaceutical sector stands to benefit from this in particular, 

as the production technologies used in this industry have often 

reached their limits. More and more manufacturers are offshoring 

locations to cut production costs or purchasing active ingredients 

from other countries. “In the chemical industry, we need a new set 

of methods for state-of-the-art production that is also sustainable 

and cost-effective,” Müller says. “This will solidify the technological 

leadership of German pharmaceutical manufacturers as they compete 

on the global stage and make Germany once again an attractive 

production location.” In this way, the Fraunhofer researchers’ new 

development will also help to safeguard Germany’s drug supply going 

forward. 

The consortium received support for their fundamental research 

in the form of both internal funds provided by the Fraunhofer-Gesellschaft 

itself and funding from the German Federal Ministry of 

Education and Research (BMBF) (ILLUMINATE project, grant 

number 031B1121). 

Fraunhofer-Institut für Grenzflächen- und Bioverfahrenstechnik IGB 

D 70569 StuttgartD 70569 Stuttgart 


page 25/38

Development of measurement technology at Wirthwein Medical 

Continuous progress 

Improved processes and efficiency 

With the commissioning of the new measuring 

machines and the expansion of the 

team, the capacity to carry out series tests 

and project-related measurements on site 

has been further increased. In the past, 

many measurements were outsourced, but 

now the team can handle these internally 

and offer the customer a direct point of 

contact. From the complete measurement 

recording to the creation of measurement 

programs to the qualification of measurement 

processes, Wirthwein Medical provides 

everything from a single source. 

Outlook into the future 

In 2019, Wirthwein Medical put a new, state-of-the-art measuring laboratory 

into operation at the Mühltal site “An der Papiermühle”. For Wirthwein Medical, 

innovative measurement technology is a crucial element in the development of 

high-quality plastic components and systems for the medical technology, pharmaceutical 

and diagnostics industries. 

Expansions and investments in the measurement 

laboratory 

Quality inspector Lucas Schiem sets up the measuring device for the 

cuvettes on the new multi-sensor measuring machine. 

There has been a lot going on in the central 

measuring laboratory at Wirthwein Medical 

since 2019. Two additional multi-sensor 

measuring machines were installed due to 

the high-capacity utilization of the previous 

measuring techniques. These machines 

combine high-precision optical, tactile 

and laser-based measuring methods in 

one system. Here, for example, cuvettes for 

blood analysis are checked in a fully automated 

process. Due to the transparency of 

the parts, precise measuring techniques are 

required to accurately detect the edges of 

the product whereby focus and lighting of 

the measuring device play a decisive role, 

as only optimal lighting conditions and precise 

focusing can make the fine details and 

contours visible and provide reliable quality 

control. “The data is forwarded directly to 

our quality assurance system and processed 

there, which ensures smooth integration 

into our existing processes,” emphasizes 

Angelo Häußler, quality inspector in the 

central measuring laboratory. 

In addition, Wirthwein Medical has added 

a new tension-compression machine 

capable of measuring forces of up to 1000 

newtons to their machine park. With this investment, 

the company has further expanded 

their range of measurement services. 

Since 2021, Wirthwein Medical has 

been developing, designing and manufacturing 

the measuring devices in-house 

thus increasing flexibility and speed considerably. 

Wirthwein Medical‘s future plans for the 

measurement laboratory include several 

core areas that will also help to meet the increasing 

demands in the industries. One key 

aspect is securing skilled workers. Continuous 

further training of the team is essential 

in order to continue to meet maximum quality 

standards in the future. 

Customer proximity is another area that 

is being focused on. Improving measurement 

capacities and communicating directly 

with customers enables Wirthwein Medical 

to respond flexibly and quickly to their 

needs and always deliver precise results, 

thereby offering an even better service. 

“The challenge of the future will be to 

meet the requirements and expectations 

of the central measurement laboratory with 

the ever-increasing complexity and order 

volume of measurement tasks,” emphasizes 

Denis Röhrig, team leader of the central 

measurement laboratory. “The last five 

years have shown that we are on the right 

track. With the investments we have made 

and the forward-looking measures we have 

taken, we are perfectly equipped to deliver 

premium quality, remain competitive and 

successfully assert ourselves in the market 

in the coming years,” he continues. 

Wirthwein Medical GmbH & Co. KG 

D 64367 Mühltal/Nieder-Ramstadt 


page 26/38

Powering Medical 

Efficiency at 

Fakuma 2024 

Conventionally, higher injection moulding 

shot weights require a larger machine. However, 

in another world first, the medical 

team at Fakuma 2024, now led by Business 

Development Director Medical Andreas 

Montag, will introduce an alternative, more 

compact 180 ton IntElect machine, powered 

by a new injection unit. 

With the introduction of a 910 injection 

unit – the largest that can be accommodated 

in this 180 ton machine – the range of 

applications in the clamping force range of 

130-180t is expanded. One of the key benefits 

of being able to select a smaller footprint 

machine that can handle larger shot weights 

are the rapid energy savings. 

To demonstrate this flexible combination 

and fine processing control, on the 

main booth exhibit, an IntElect machine will 

mould syringe plungers with a shot weight 

of 29 grams, from a non-porous High-Density 

Polyethylene (HDPE) every 6,5 seconds, 

using a 32-cavity tool. This specific showcase 

is realised in cooperation with elmplastic, 

who also supply the tool, cooling 

system and additional peripherals. 

“This highly efficient yet compact cleanoptimum 

screw size is selected to suit each 

medical application. Further increasing processing 

flexibility and production capacity. 

Rather than automating the removal of 

components, this exhibit instead utilises a 

QA switch installed within the production 

cell. When the mould opens, the syringe 

plungers cascade onto the conveyor belt 

where rejected parts are segregated and the 

good parts weighed and counted into a changeable 

boxing system supplied by AM Plastics. 

“All of this is achieved without sacrificing 

any floorspace – productivity is increased by 

using floor and vertical space more efficiently, 

increasing output volume per square metre,” 

highlights Andreas Montag. 

Scalable medical solutions 

At Fakuma 2024, Sumitomo (SHI) Demag will introduce a powerful new injection unit which 

expands the range of applications in the clamping force range of 130-180t. 

Efficiency in the medical sector is reliant on equal measures of precision and 

mass-production. It lays the foundation for reducing healthcare costs for patients 

and medical providers. At Fakuma 2024, Sumitomo (SHI) Demag has showcased 

how scalable solutions can be implemented to optimise productivity while 

simultaneously lowering the manufacturing cost per unit. 

room medical production cell is characterised 

by its repeatability and cleanliness. Built 

for high speed and precision, it is designed 

to handle extremely narrow tolerance medical 

applications produced in high volumes 

in the most efficient way, yet give processors 

the flexibility to mould everything from 

small medical parts to larger components,” 

expands Andreas Montag. 

On the main booth, syringe plungers are 

manufactured in a highly efficient and compact 

clean room production cell. 

The ability to add a 50 mm screw allows 

processors to mould larger parts. Having 

the option to rapidly switch between three 

screw sizes (45, 50, and 60 mm, with the 

option to add 55 mm too), ensures that the 

As specialists in medical processing, HE- 

KUMA on booth A7-7202 will present one 

of its scalable and flexible cleanroom configurations 

designed for petri dish production. 

Integral to this medical package is the 

IntElect2 100 system. HEKUMA describes 

this year’s presentation an excellent example 

of a well-considered, automated, scalable 

turnkey system. Making it ideal for 

smaller production runs as well as delivering 

more value to mass manufacturers of medical 

components. 

Drawing upon the complementary 

strengths of Asian tooling specialist Jestar 

Mold Tech, the HEKUMA collaboration also 

demonstrates how high-end and innovative 

solutions can work together and be cost 

efficient. Rather than using a conventional 

stack mould to manufacture petri dishes, 

Jestar supplies the 2+2 single face tool to 

support a seven second cycle time and high 

production output. Hekuma provides the 

automation itself: a 6-axis robot removes 

the parts by side removal. 

However, cost efficiency doesn’t mean 

compromising on standards. To maintain 

compliance with the explicit quality management 

and validation ISO 13485 standards 

for medical devices, the IntElect 

machine comes with set user parameters. 

This helps to ensure that processes are kept 

within certain bandwidths and that users 

do not make adjustments to pressure, temperature, 

flow and cooling settings without 

permission. 

Each of the eight Sumitomo (SHI) Demag 

exhibits at Fakuma 2024 exemplifies 

the close collaborative approach that the 

company adopts with all industry partners, 

and the united drive to boost efficiency for 

processors locally and globally. 

Sumitomo (SHI) Demag 

D 90571 Schwaig 


page 27/38

With 1010 exhibitors from 49 countries and 32,796 trade visitors, Chillventa 2024 

was a complete success and was all about Connecting Experts. 

Chillventa 2024 – A gathering of experts: 

Innovations, dialogue, and insights 

into the future of the sector 

Chillventa 2024 impressed the professional community across the board. 1,010 exhibitors from around 49 countries presented 

their latest products and services to 32,796 experts from all over the world. The extensive supporting programme, 

including a record-breaking more than 250 presentations at the Chillventa CONGRESS and four forums, and two top-class 

special presentations offering practical expertise, encouraged participants to linger, network and engage in professional 

discussions. This year, the focus was on topics like sustainability, the circular economy, and digitalisation. The Chillventa 

CONGRESS on the day before the fair attracted 300 delegates and impressed with high-calibre presentations by international 

speakers. 

With its diverse range of topics and a programme that had been enlarged 

yet again, Chillventa 2024 provided a comprehensive overview 

of current developments in refrigeration, AC, ventilation and 

heat pump technology along with interesting insights into the future 

of the sector. 

“Refrigeration technology, including the segments ventilation, 

AC and heat pumps, is a technology of the future. This was reflected 

in the many topics like energy transition, digitalisation, heat pumps 

and refrigerants in the context of sustainability and the circular economy 

that were discussed this year in the congress, at the exhibition 

stands, or in special presentations. Once again, Chillventa underscored 

its position as the No. 1 among refrigeration technology fairs not 

just for its coverage of industry issues but also because of the 1,010 

exhibitors from 49 countries, resulting in fully booked exhibition 

halls. Its metrics have now stabilised at pre-pandemic levels again. 

But the 32.796 visitors (2022: +7,5%) were also emphatic proof that 

Chillventa is the most important trade fair for the community. The 

mood in the halls was excellent and the atmosphere akin to that of 

a large family gathering. Chillventa will continue to be the key event 

worldwide for the refrigeration sector including the air conditioning, 

ventilation and heat pump segments,” says Daniela Heinkel, Director 

of Chillventa and the European Heat Pump Summit at Nürnberg- 

Messe. 

High-calibre visitor profile 

Around 57 percent of the 32.796 Chillventa visitors came from outside 

Germany. The exhibitors were once again impressed by the 

quality of the trade visitors, of whom over 80 percent were directly 

involved in the purchasing and procurement decisions at their companies. 

Nine of ten were satisfied with what was on offer, and more 

than 95 percent planned to take part in the next Chillventa. 

“In 2024, the visitor profile at Chillventa was once again highly 

diverse and included manufacturers, system operators, dealers, 

building services designers, architects and tradespeople. This meant 

that all key target groups were once again united on the grounds 

of NürnbergMesse – at their Chillventa,” says Daniela Heinkel. Kai 

Halter, Chair of the Chillventa Advisory Board and Vice President 

Marketing and Brand Management at ebm-papst, was equally enthusiastic: 

“Chillventa was an outstanding event by experts for experts 

– and met the highest professional standards in all respects. 

We are already looking forward to 2026!” 

Numerous exhibitors set to attend again 

This consistently positive overall picture of Chillventa was also confirmed 

by the independently conducted exhibitor survey. Most exhibitors 

(by area) came from Germany, Italy, Turkey, China, Spain, 

Belgium, the UK, France, Poland and the USA. Around 95 percent 

of exhibitors rated their participation in Chillventa as a success, while 

around 95 percent were able to forge new business contacts and 

expected successful post-show business. Even before the event was 

over, around 94 percent of the 1,010 (2022: +20%) exhibitors confirmed 

that they would be exhibiting again at Chillventa 2026. 


page 28/38

Extensive supporting programme impressed the 

professional community 

The Chillventa supporting programme already has a long 

tradition and has always offered high-quality solutions to 

current issues. This year too, the programme was expanded 

yet again and offered the experts making the trip to 

Nuremberg specialist knowledge precisely tailored to their 

needs. “The supporting programme is a vital component of 

Chillventa and offers first-hand expertise. Over the four-day 

event in 2024, industry experts enjoyed more than 250 firstclass 

presentations at the Chillventa CONGRESS and four 

forums that delivered precisely targeted information on the 

latest products, trends and technologies. Some of the key 

topics under discussion were refrigerants, heat pumps in industrial 

and commercial applications, sustainability, the F- 

gas regulation, PFAS, and the circular economy,” explains Dr 

Rainer Jakobs, technical consultant and coordinator of the 

supporting programme at Chillventa. 

In the “PRACTICAL GUIDE TO DIGITISATION” forum, 

the focus was on increasing efficiency, productivity and revenue 

in skilled trade businesses through digitisation. Here, 

professionals from various businesses provided insights into 

their real-life processes. 

On a special display area under the banner “Refrigerant loss 

and no leak detected. How it works!”, the German Federal 

College of Refrigeration and Air Conditioning Technology 

conducted demonstrations on leak detection and tightness 

testing. The second special presentation, the “AIT Heat 

Pump Innovation Lounge” was devoted entirely to the topic 

of heat pumps. Here, experts from the Austrian Institute of 

Technology (AIT) presented their latest developments and 

research findings e.g. on the question of heat pumps as a 

substitute for gas boilers in residential buildings. 

The supporting programme was rounded out by several 

themed guided tours and last but not least, the German 

Championship for Refrigeration Technicians organised by 

the Federation of German Refrigeration Plant Assemblers 

(BIV). “In 2024, the best young refrigeration technicians 

were once again honoured in the German Championship 

for Refrigeration Technicians. We are delighted that the 

BIV hosts the championship at Chillventa. Congratulations 

to all participants and the German champion,” says Daniela 

Heinkel. 

Next stop: European Heat Pump Summit 2025 

The next highlight in the trade fair calendar for heat pump 

professionals is the European Heat Pump Summit to be held 

at Exhibition Centre Nuremberg on 28 and 29 October 2025. 

Save the date: Chillventa 2026 

The next Chillventa will take place at Exhibition Centre Nuremberg 

from 13 to 15 October 2026. On the day before, 12 

October 2026, the Chillventa CONGRESS will launch the 

week of events for the international refrigeration, AC, ventilation 

and heat pump community. 

NürnbergMesse GmbH 

D 90471 Nürnberg 

FACHPACK 2024: 

Clear guide for a 

packaging 

sector in transition 

“That was the kind of FACHPACK we know and 

love!” – That was the general consensus among exhibitors 

and visitors at FACHPACK 2024, which has 

just closed following a highly successful three-day 

event. Thirty-seven thousand trade visitors, one 

third from outside Germany, learned about the latest 

trends and innovations at the stands run by the 1,455 

exhibitors, and discussed pressing packaging issues 

with the experts. The key theme of “Transition In 

Packaging” was strongly in evidence in all the exhibition 

halls and in the supporting programme. “The 

great response speaks for itself: Despite the changes 

happening in the packaging industry and the many 

challenges it is facing, the European packaging sector 

at FACHPACK proved extremely innovative, solution-oriented 

and confident,” says Heike Slotta, 

Executive Director Exhibitions at NürnbergMesse, 

summing up the event. In 2025, FACHPACK will be 

held at the Exhibition Centre Nuremberg together 

with POWTECH TECHNOPHARM. 

“Once again, FACHPACK has shown itself to be a clear 

guide and driving force for the packaging industry in Europe,” 

says Slotta, summing up the mood at FACHPACK 2024. 

“And that’s what we need! The packaging sector is in a state 

of transition. New regulations have to be implemented, and 

high expectations in terms of sustainability and the circular 

economy need to be met. At the same time, the industry faces 

challenges brought about by demographic change. And 

then there are other themes relating to the energy supply 

system, supply chains, digitalization and artificial intelligence. 

Here in Nuremberg we’ve just had three days of experiencing 

first-hand just how innovative, solution-focused 

and optimistic the industry is in dealing with these challenges 

and helping to structure the transition. The FACHPACK 

motto ‘We create the future’ once again sums it up nicely.” 

Visitors from throughout Europe 

FACHPACK offered an extensive range of solutions and innovations 

in the areas of packaging, packaging systems and 

packaging processes. Most visitors to FACHPACK travelled 

to the Exhibition Centre from other countries in Europe. 

After Germany, the top ten countries were Austria, Switzerland, 

Italy, the Czech Republic, Poland, the Netherlands, 

France, Spain, Turkey and Hungary. The international contingent 

made up 33 percent of the total. 


page 29/38

Industry professionals: Top decision-makers onsite 

The results of a visitor survey by an independent institute confirmed 

that 96 percent of the industry professionals were happy with the 

products and services in the exhibition halls. Some 90 percent of the 

trade visitors said they were involved in making the purchasing and 

procurement decisions in their respective businesses. Two thirds of 

them hold management positions. The visitors came mainly from 

the food and feed, pharmaceutical and medical, chemical, cosmetics, 

retail, automotive, electrical and electronic, non-food, logistics 

and packaging industries. 

Women4Packaging network off to a successful start 

The Women4Packaging networking event was very well received, 

with 150 female industry players seizing the unique opportunity 

on the first day of the trade fair to network onsite and interact on 

current themes and trends in the packaging sector. The keynote by 

Vera Strauch, founder of the Female Leadership Academy and expert 

in Feminist Leadership, provided stimulating ideas. This initial 

gathering received a thoroughly positive response, and the Women- 

4Packaging network will be continued and expanded accordingly, to 

ensure a focus on women in the packaging industry in the future. 

Regular meetings are planned. Phuong Anh Do, Deputy Director 

FACHPACK, is overwhelmed by the response to the new industry 

platform: “There are many qualified women in the packaging industry. 

That’s why we’re particularly pleased to have created a trail-blazing 

network for women at FACHPACK in the form of Women4Packaging, 

which offers female players in the industry an opportunity 

for constructive interaction with like-minded colleagues and genuine 

added value.” 

German Packaging Award and Gold Awards presented 

On the first day of FACHPACK, the German Packaging Institute 

(dvi) announced the winners of the Gold Awards for this year’s 

German Packaging Award. The five best innovations for 2024 came 

from the categories of Digitalization, Functionality & Convenience, 

Sustainability and Packaging Machines. A total of 41 innovative solutions 

that were recognized with the German Packaging Award in 

August were celebrated. 

New: Packaging Valley organizes Packaging Machinery Forum 

in collaboration with FACHPACK in 2025 

In early summer 2025, Packaging Valley and FACHPACK will join 

forces for the new Packaging Machinery Forum format. This leading 

forum for packaging machine construction will offer exclusive 

insights into the future of the sector. It will focus on topics of interest 

to customers of the packaging machine construction industry. 

Technological themes such as digitalization will be given the same 

prominence as questions of business models, market developments, 

and how to ensure future-proof production. Participants can also 

look forward to customized sessions run by top-level experts to deal 

with individual questions. The forum also offers an ideal platform for 

networking, which enables direct connections to decision-makers 

and leading thinkers in the sector. More information will follow soon. 

Save the date: The next FACHPACK will take place together with 

POWTECH TECHNOPHARM at the Exhibition Centre Nuremberg 

from 23 to 25 September 2025. 

NürnbergMesse GmbH 

D 90471 Nürnberg 


page 30/38

Precisely one year from now K in Düsseldorf will open its doors for the global plastics 

and rubber industry from 8 to 15 October 2025. 

K 2025: The countdown has begun 

The preparations for K 2025 in Düsseldorf are in full swing, 

the exhibition space is already fully booked. Numerous proven 

and new specials hone in on the motto “The Power of 

Plastics! Green – Smart – Responsible”. The exhibitor database 

will go live in January 2025. 

From 8 to 15 October the global plastics and rubber industry will 

come together for its internationally most relevant trade fair in Düsseldorf. 

Like no other trade fair of this sector, K 2025 will provide 

the complete overview of this industry’s global ranges – once again 

guaranteed by the international origin of exhibitors. Enterprises 

from all continents have registered to offer trade visitors highest-level 

innovations. “Next year the Who’s Who of the plastics and rubber 

industries will be back again in Düsseldorf. We are very pleased that 

even companies who had suspended their participation in 2022 as a 

consequence of the pandemic, are now back on board again,” says 

Thomas Franken, Director K, Portfolio Plastics & Rubber. The conversations 

on stand space allocation are currently underway before 

the K 2025 exhibitor database goes live. 

At K 2025 under the heading “The Power of Plastics! Green – 

Smart – Responsible” the focus will be just as much on trends and 

innovations related to the circular economy and digitalisation as on 

the responsibility for people and the planet. This is reflected by both 

proven and new specials: first and foremost, the official special show 

“Plastics shape the Future” organised by Plastics Europe Deutschland. 

Also presenting a comprehensive forum on the outdoor premises 

again will be the VDMA – this time entitled “The Power of 

Plastics”. 

The Start-up Zone successfully debuted at the last K. It will also 

be continued in 2025 and expanded to provide a dedicated presentation 

area for as many newcomers as possible who are particularly 

committed to the development of innovative products and solutions 

in the fields of plastics and rubber. Start-ups still now have the opportunity 

to register for the Start-up Zone. 

At the Science Campus universities, colleges and institutes will 

share the latest results of their plastics research. A new concept of 

the Science Campus allows exhibitors to optionally also take part in 

the Science Campus Center in addition to participating with their 

own exhibition stands. 

In addition, a new offering is currently being developed for young 

visitors and career starters with a view to familiarising them with the 

diversity and appeal of the sector. Beyond this, a networking event 

will be organised specifically for women in the plastics and rubber 

industry to promote mutual exchange, strengthen professional networks 

and give visibility to female leaders in the industry. Both formats 

will celebrate their premiere at K 2025. 

Messe Düsseldorf GmbH 

D 40001 Düsseldorf 


page 31/38

International expert meeting for trends and innovations in laboratory medicine - the MEDICA LABMED FORUM at MEDICA 

(© Constanze Tillmann/ Messe Düsseldorf) 

“Lab 4.0”, shortage of skilled personnel, 

incentives for major disease complexes and a look ahead 

MEDICA LABMED FORUM 2024: 

International experts meet to discuss 

trending topics in laboratory medicine 

What are the most exciting developments in medicine right now? At MEDICA in Düsseldorf, the world’s leading trade fair 

for the healthcare business and the medical technology industry, the professional forums and their accompanying stage 

programme at the heart of this year’s trade fair (11–14 November) will take a deeper look into these developments, for example 

in the fields of health IT, trends in medical technology, healthcare policy and laboratory medicine. With its informative 

short lectures and professionally grounded panel discussions, the MEDICA LABMED FORUM has become one of the main 

attractions of the MEDICA accompanying programme in recent years. 

With a view to this year’s thematic focus, Prof. Stefan Holdenrieder 

of the German Heart Centre in Munich (DHM), who is the Scientific 

Director of the MEDICA LABMED FORUM, points to the trend 

towards massive digitalisation and networking as well as big data 

applications and artificial intelligence (AI), currently summarised 

under the heading “Lab 4.0”. “We have so far mainly considered individual 

lab results. In future we will analyse more and more complex 

data patterns using machine learning and aggregate them as 

complex diagnostic scores. Lab medicine is currently evolving from 

a purely analytical discipline in the direction of data science. In this 

process, interdisciplinary collaboration between laboratory technicians 

and specialised data scientists, especially computer scientists 

and biostatisticians, is becoming increasingly important.” 

Day 1: Shortage of skilled personnel and digitalisation 

On the opening day of MEDICA 2024 (11 November), the MEDICA 

LABMED FORUM will focus on the highly topical subject of digitalisation 

and AI, headed by Prof. Thomas Streichert (MD), University 

Hospital Cologne. The morning session will be dedicated to the 

shortage of skilled personnel, which is the most pressing problem 

for laboratory medicine according to recent surveys. As Head of the 

Young Laboratory section of the German Society for Clinical Chemistry 

and Laboratory Medicine (DGKL), Dr Ronald Biemann of the 

University of Leipzig Medical Center will report on the shortage, in 

some cases dramatic, of future personnel in the medical and medical-technical 

fields. In the panel discussion, the speakers will explore 


page 32/38

of Munich will shed light on the topic from a clinical perspective, 

and mathematician Prof. Frank Klawonn of the Helmholtz Centre in 

Brunswick, a visiting researcher at the Heart Centre, will demonstrate 

possibilities for modern data evaluation using machine learning. 

In the afternoon the topic of highly sensitive cancer diagnostics 

of blood is on the agenda. With this examination technique, known 

as the “liquid biopsy”, lab medicine opens up completely new avenues 

in oncology to monitor tumour progression more closely than 

is possible with conventional tissue biopsies. This allows early detection 

of when a treated cancer will flare up again and require a change 

in treatment. New methodological approaches such as the analysis 

of methylation profiles for early detection of hereditary forms of 

cancer or single-cell analysis using microfluidics will be discussed. 

Day 3: Future prospects for laboratory medicine 

Trade fair visitors in the Laboratory Equipment & Diagnostics area 

(© Constanze Tillmann/ Messe Düsseldorf) 

On the Young Scientists’ Day of the MEDICA LABMED FORUM, 

the next generation of researchers present their perspective on the 

future of laboratory medicine. As an introduction, university lecturer 

Dr Verena Haselmann (MD) of the University Medical Centre Mannheim 

will give an overview of the most recent progress in the field 

and obstacles that still need to be overcome. Wearables for the continuous 

recording of diagnostic parameters are one such new opportunity, 

while new quality requirements and the shortage of skilled 

personnel are some of the obstacles. In the afternoon the discussion 

will focus on personalised therapy based on individual patterns of 

laboratory parameters, the interdisciplinary synergy of laboratory 

and imaging in integrated diagnostics and the use of artificial intelligence. 

Day 4: Healthy ageing 

solutions to the crisis with the help of automation and digitalisation. 

In the afternoon, the focus will be on AI and big data tools that 

are already available or still under development. Image recognition 

using deep learning is already state-of-the-art for the automated 

analysis of leucograms, while machine learning based on large multivariate 

data sets that occur every day in laboratory diagnostics is 

still at a developmental stage. The exciting question of how large 

language models can help to make abstract laboratory findings more 

understandable and whether AI really makes us smarter (or possibly 

dumber) will also be discussed. 

Day 2: Trends in cardiology and oncology 

Traditionally, on the second day of the trade fair Prof. Stefan Holdenrieder 

leads a discussion on current developments in laboratory 

medicine for the two disease complexes most driving mortality in 

the Western world, cardiovascular diseases and cancer. This year, 

the cardiology focus is on congenital heart defects. They can increasingly 

be corrected surgically in childhood and also play a growing 

role in adult medicine due to improvements in life expectancy. Lecturers 

from the German Heart Centre and the Technical University 

The final day of the forum traditionally focuses on diagnostic research 

institutes and companies that want to open the door to new 

fields of application in lab medicine. Both sessions will be led by 

members of the German Diagnostics Industry Association (VDGH), 

Dr Kai Prager and Dr Peter Quick. Their topic for 2024 is research 

on ageing from the perspectives of pathophysiology, diagnostics and 

treatment. The latest findings on the genetic and epigenetic biological 

clock, protein misfolding and aggregation as the basis of neurodegenerative 

diseases like Alzheimer’s and Parkinson’s and the role 

of gut microbiota during strokes are some of the topics that will be 

discussed. 

As the „grand finale“, interesting theories and practical experiences 

in how to slow the ageing process will be discussed in the afternoon. 

Prof. Emrah Düzel of the University of Magdeburg will present various 

anti-ageing drugs, Prof. Wolfram Ruf of the University of Mainz 

will describe the effects of anti-inflammatory agents, Prof. Dres. 

Monique Breteler of DZNE, the German Centre for Neurodegenerative 

Diseases, will hold a talk about the influence of the environment 

on ageing in the central nervous system and Prof. Claire Jacob, also 

of the University of Mainz, will discuss possibilities to repair lesions 

in the nervous system. 

At present about 6,000 companies have booked a spot at MEDICA 

2024 and COMPAMED 2024, the supplier trade fair held in parallel 

(from 11–14 November). In the year before, both events recorded a total 

of 83,000 visitors. 

Messe Düsseldorf GmbH 

D 40001 Düsseldorf 


page 33/38

PC 4000 continuous motion cartoner from Romaco Promatic. (Photo: Romaco Group) 

Romaco at PACK EXPO International 2024 

Sustainable processing and 

packaging technologies all from one source 

This year’s PACK EXPO International in Chicago (USA) will be an opportunity for the Romaco Group to showcase its technologies 

for compressing and coating tablets as well as for the secondary packaging of ophthalmic products. All machines 

from this one stop solutions supplier are developed and manufactured in accordance with the Group’s high sustainability 

standards. 

Romaco’s portfolio covers the entire process chain for manufacturing 

and packaging pharmaceuticals, nutraceuticals, food, cosmetics 

and chemical products. Whether as stand-alone machines or integrated 

lines, the one stop supplier’s solutions can be flexibly configured 

and are also extremely versatile. Romaco’s technologies score 

with excellent overall equipment effectiveness (OEE) based on top 

quality and performance as well as optimized retooling and cleaning 

times. 

Sustainable system design is a key development priority with all 

of the manufacturer’s products. True to the principle of “avoidance is 

better than reduction is better than compensation”, Romaco has significantly 

improved its machines’ carbon footprint. Earlier this year, 

the company earned a silver medal in the EcoVadis Sustainability 

Rating for its commitment to climate protection. 

Romaco will take advantage of the upcoming trade fair to show 

the KTP 1X compaction simulator from Romaco Kilian, the TPR 25 

Pilot tablet coater from Romaco Tecpharm and the PC 4400 high 

speed continuous motion cartoner from Romaco Promatic. 

PC 4400 continuous motion cartoner from Romaco Promatic 

with ophthalmic bottles feeding 

The PC 4400 high speed continuous motion cartoner from Romaco 

Promatic is designed for processing a very wide range of products. 

With its safe product handling concept, the cartoner is perfect for 

packaging extra-lightweight plastic bottles with small diameters and 

low filling volumes, such as those used for ophthalmics. A double 

conical wheel infeed system ensures safe transfer of the bottles to 

the cartoner, even at the machine’s maximum speed. The cartoner 

can also be configured for feeding ecotrays with vials placed upright. 


page 34/38

flexibly integrated into the diverse packaging concepts of the pharmaceutical, 

nutraceutical, cosmetics, food and chemical industries. 

TPR 25 Pilot mobile tablet coater from Romaco Tecpharm 

for batch sizes from 5 to 100 percent 

KTP 1X compaction 

simulator from 

Romaco Kilian. 

(Photo: Romaco Group) 

The TPR 25 Pilot mobile tablet coater is an extremely compact pilotscale 

unit for simple plug & play commissioning. For this purpose, 

all inlet and exhaust airflow systems required for the coating process 

have been integrated into the machine. As a modern all-in-one 

solution, its applications cover everything from development activities 

and scale-ups to the production of very small batches. The pilot 

coater is designed to handle batches weighing anything from 1 to 25 

kg, making it suited for an extremely wide batch size range from 5 to 

100 percent. The coating pan’s enormous flexibility is made possible 

by fully automated processes requiring no manual adjustments. 

The TPR 25 Pilot is equipped with a patented spray arm, which is 

controlled by a sonar system that automatically adjusts the distance 

between the spray gun and the tablet bed. Thanks to the spray arm’s 

intelligence, the coater does not have to be stopped and opened to 

correct the spray distance while the process is running. In addition 

to this, the extendable spray arm has movable nozzles to ensure the 

ideal spray angle in any situation. The process air flowing through 

the tablet bed follows a precisely controlled path, which can be automatically 

adapted to the filling level in the drum with the aid of an 

exhaust flap that opens steplessly. This results in remarkably accurate 

application of the coating suspension and ultra-efficient drying of 

the tablet bed. From a sustainability viewpoint, Romaco Tecpharm’s 

TPR 25 Pilot consequently impresses with significantly shorter processing 

times coupled with lower energy and spray liquid consumption. 

Romaco Kilian KTP 1X compaction simulator 

for digital tablet development 

TPR 25 Pilot tablet coater from Romaco Tecpharm. 

(Photo: Romaco Group) 

Depending on the requirements, glass vials, tubes, strips, blisters and 

countless other products can likewise be packaged quickly and reliably. 

The Promatic PC 4400 achieves a maximum output of 400 cartons 

per minute. Its positive carton opening system means that there 

is no friction whatsoever, paving the way for gentle handling, especially 

where recycled cardboard is concerned. The GMP-compliant 

balcony design and ergonomic working height moreover speed up 

safe line clearance. The cartoner’s buckets are produced by 3D printing 

so that material consumption during the manufacturing process 

is radically curtailed. Numerous anodized aluminum components 

and the recycled acrylic glass housing further reduce the cartoner’s 

carbon footprint. If required, Romaco Promatic’s PC 4400 can be 

The KTP 1X is Romaco Kilian’s smart compaction simulator for tablet 

development using digital tools. This all-in-one instrument was designed 

for research and development activities, but also allows targeted 

troubleshooting and process optimization in addition to upscaling. 

The single-stroke press is capable of simulating any standard 

rotary press, making it much easier to conduct technology transfer 

and scale-up trials, among other things. The versatile measurement 

system is perfect for designing and analyzing mono-layer, bi-layer 

and triple-layer tablets as well as tab-in-tab formats. The KTP 1X determines 

the ideal compression force/hardness profile for any tablet 

design, taking account of the various ingredients and parameters. Its 

compression studies are highly automated, and so only a few test series 

are needed to obtain meaningful results when characterizing a 

formulation. This high measuring accuracy goes hand in hand with 

extremely low product consumption – a significant factor when it comes 

to economy and sustainability. A special data module gives users 

worldwide secured access to raw measurement data at any time, 

even when the press is not in operation. Decentralized data analysis 

and processing has numerous advantages, enabling research 

projects to be implemented more efficiently. Thanks to its very small 

compaction area, this space-saving instrument fits conveniently into 

any laboratory as well as being quick and easy to clean. Depending on 

the model, Romaco Kilian’s KTP 1X achieves compression forces of 

up to 80 kN with a maximum output of 1800 tablets per hour. 

Romaco Group 

D 76227 Karlsruhe 


page 35/38

The eSIGN LED signal tower clearly and reliably indicates the current status of the production line in the 

standard traffic light colours red, yellow and green. 

Maximum safety in food production 

thanks to the eSIGN LED signal tower 

Safety and quality are paramount in the production, processing and 

packaging of food. Compliance with hygiene regulations and the 

guarantee of first-class end products is a top priority. Consumers expect 

high-quality and hygienically flawless products, while manufacturers 

rely on smooth, process-optimized and efficient production. 

An important aspect of this is the detection of foreign bodies 

and contaminants that could impair the quality and integrity of the 

food. This is where X-ray inspection devices from Sesotec come into 

play, reliably detecting and identifying foreign bodies in unpackaged 

and packaged products. 

A key component of the X-ray scanners is the eSIGN LED signal 

column. Thanks to its bright signals, it clearly and reliably displays 

the current status and thus not only ensures a quick and clear overview 

of the inspection process, but also enables rapid intervention 

and reaction in the event of faults or error messages. 

Sesotec reliably detects foreign objects 

Sesotec was founded almost 50 years ago in Schönberg, Bavaria. 

The company is a leader in the field of mechanical engineering for 

foreign object detection, material sorting and analysis and has always 

been firmly rooted in the Bavarian Forest. Johann Süß has been 

working as an X-Ray Engineer in the Electrical Design department 

at Sesotec for five years and smiles: „We work where others go on 

vacation!“ 

The company now employs more than 740 people and, in addition 

to its headquarters in Germany, is represented by a total of six 

subsidiaries in Singapore, China, USA, India, Canada and Thailand, 

six foreign subsidiaries in Italy, France, Spain, Poland, the Czech Republic 

and Malaysia, as well as over 60 partners in all major markets 

around the world. 

Maximum safety thanks to X-ray scanner 

At Sesotec, the focus is on top quality combined with passion and 

technological progress. „It is our goal and our aspiration to be able to 

offer every customer a tailor-made solution that not only meets their 

requirements, but exceeds them,“ says Johann Süß. „On this basis, 

we have developed an X-ray inspection system specifically for users 

in the food industry that immediately detects foreign objects in unpackaged 

products clearly, quickly and reliably.“ 

The „RAYCON D+ HX LW Hygienic“ X-ray inspection system 

not only offers maximum performance in the inspection of unpackaged 

food and bulk goods, but also meets the highest standards, 


page 36/38

„For our X-ray scanners, we were looking for a light that not only 

had a high degree of protection, but also complied with all applicable 

regulations in the food sector and was constructed in accordance 

with hygienic design guidelines.“ He continues: „We have already 

been using various signaling devices from WERMA for many years. 

In the course of this project, however, we also looked at solutions 

from competitors. However, no other beacon was able to meet the 

high requirements and we are very pleased that we have once again 

found what we were looking for at WERMA.“ 

Gottfried Zeidler works in technical sales at WERMA and immediately 

introduces Sesotec to the new, elegant and versatile eSIGN 

LED signal tower. „This signal tower has been developed, tested and 

certified according to the highest criteria and bears the „Fraunhofer 

Tested Device“ seal of approval - an internationally renowned test 

mark for products that have been objectively qualified according to 

recognized standards and guidelines with regard to their cleanroom 

suitability,“ says Zeidler. „In addition, the high degree of protection 

IP66 / IP69k ensures improved resistance to typical production substances, 

while UL Type 4X guarantees resistance to UV radiation and 

environmental influences. Simply the perfect solution for status indication 

in the food production sector!“ 

eSIGN LED signal tower - the best signal tower 

ever with IP 69K 

complies with all important food industry guidelines and applies the 

principles of hygienic design. „This combines highly efficient foreign 

body detection with maximum user-friendliness and hygienic design,“ 

says Johann Süß. „And reliable protection against complaints 

and recalls can be ensured.“ 

Clear signals to indicate faults 

The way the RAYCON D+ BULK series works is very simple: the bulk 

materials are distributed evenly across the entire width of the conveyor 

belt via an integrated feed hopper and inspected. The X-ray 

scanners not only detect metals, but also contaminants such as glass, 

ceramics, raw bones, PVC and stone. 

„As soon as the scanner detects a foreign object - no matter how 

small - it is sorted out. The system stops immediately in the event of 

an „error status“ and the signal light clearly indicates this,“ explains 

Johann Süß. „The yellow light of the eSIGN LED signal tower cannot 

be overlooked. This allows the machine operator responsible to react 

immediately and not only prevents contamination of the food, but 

also avoids long downtimes. This saves time ,money and increases 

productivity!“ 

Hygienic design - down to the last detail 

The materials of all components of the RAYCON D+ HX LW Hygienic 

are designed for the high protection class IP69 so that they 

can be cleaned repeatedly and intensively without abrasion. These 

requirements were also placed on the signal towers that were to be 

used. 

The eSIGN is a shining example of a signal tower with visibly more 

performance: more colours, more effects, more flexibility and more 

individuality! Thanks to electrical modularity combined with the 

latest LED technology, various signaling modes with multiple colours, 

brightness levels and illuminated images can be implemented 

- from the classic traffic light display to completely customerspecific 

settings. 

Sesotec uses the version with 9 segments, which display the current 

status in the colours red, yellow, green and blue over the entire 

surface. If the red signal lights up, the X-rays are on, green means the 

food is being inspected, yellow indicates a fault in the system and the 

blue signal indicates an audit check. In addition, this visual display is 

reinforced by an audible alarm, which uses an insistent, loud tone to 

indicate that there is a fault condition, e.g. the inspection is interrupted 

or the conveyor belt is at a standstill. 

„We at Sesotec are delighted with the elegant design, the excellent 

workmanship and the simple installation and easy integration 

into our systems,“ says Johann Süß. „What‘s more, the eSIGN has all 

the necessary approvals and the required high degree of protection 

- simply perfect!“ 

Johann Süß says: „The bright and loud signal tower shows the 

current status of our RAYCON D X-ray scanners safely and reliably. 

Our customers are happy and so are we, of course!“ 

When asked whether the eSIGN LED signal tower was able to 

meet expectations, Süß replies with a smile: „100%! The eSIGN is by 

far the best product for our application!“ 

WERMA Signaltechnik GmbH + Co. KG 

Dürbheimer Straße 15 

D 78604 Rietheim-Weilheim 

Telefon: +49 7424 95570 

Telefax: Fax +49 7424 955744 

eMail: info@werma.com 

Internet: http://www.werma.com 


page 37/38

Ultra-flat 15“ stainless steel enclosure with IP69k protection. 

Designed for high hygienic requirements. 

New Stainless Steel Touchscreen 

Industrial Monitor 

– Hygienic and Robust 

WEROCK Technologies GmbH presents the new Rocksmart 

RSD1015, a 15“ industrial monitor with IP69k protection. Designed 

for demanding use in harsh industrial environments with high dust 

or steam generation and high humidity, where hygiene plays a central 

role. 

The Rocksmart RSD1015 is waterproof and dustproof thanks to 

its fully sealed design to IP69k. The compact housing is made of 

stainless steel, which is resistant to acids, detergents and other chemicals. 

The material also provides protection against corrosion and 

bacterial growth. The rounded corners and smooth surface of the 

stainless steel housing make it easy to clean, even with a high-pressure 

washer, making it suitable for use in areas such as the food and 

pharmaceutical industries. 

The high-quality, high-contrast display is easy to read from a 

viewing angle of up to 88° from any direction. The manufacturer also 

promises a long service life with an average operating time of up to 

50,000 hours. For use in very bright environments with direct sunlight, 

an optional version with up to 1,000 nits luminance is available, 

and the Clarity Display is offered as an option for increased color 

brilliance. An optional IR/UV filter provides extended protection 

against the effects of sunlight. 

The Rocksmart RSD1015 can be equipped with either a resistive 

single-touch or capacitive multi-touch display. The capacitive 

touchscreen enables operation with bare fingers or conductive gloves 

and supports gesture control similar to tablets or smartphones. 

In work environments where thick or non-conductive gloves are 

worn, the resistive touchscreen offers pressure sensitivity. 

Markus Nicoleit, Managing Director of WEROCK, explains the 

market launch of the Rocksmart RSD1015: “The Rocksmart RSD1015 

provides the ideal combination of robustness and high hygienic 

requirements. The stainless steel display is ideal for easy cleaning 

and at the same time offers complete all-round protection against 

all external influences. It supports our customers with high hygienic 

requirements in all harsh working environments.” 

The new Rocksmart RSD1015 is now available from WEROCK 

Technologies GmbH and its sales partners. 

WEROCK Technologies GmbH 

D 76131 Karlsruhe 

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 

The contributions mentioned by name are the responsibility of the particular author. Reprinting, also of extracts, are permitted only with the approval of 

the editor and with reference to the source. The publisher does not accept any responsibility for unsolicited manuscripts and illustrations. The publisher 

is granted the exclusive, spatial, temporal and contentual limited right to freely use the article in unchanged or edited form for all purposes as often as 

desired or to transfer it to third parties for use. This right of use relates to print and electric media (Internet, databases, data carriers of all kinds). 


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