Newsletter_10-2023_EN

EN 10/23
Safeguarding hospitals
and healthcare centers
with vaporized hydrogen
peroxide

Safeguarding hospitals and healthcare
centers with vaporized hydrogen peroxide
Iacobus is the Greek variant of the Hebrew word meaning “held by the heel”, but the original definition is thought to come
from an Aramaic phrase for “may God protect.” Founded in 2014 in Łódź, Poland, Iacobus Sp z.o.o offers decontamination
services and equipment. Iacobus also services and sells medical devices and is an authorized dealer of products from CLEA-
MIX, KEN instrument washers, TBT medical, MDG Engineering srl, CASPR Group.
Piotr Węgier, lead service engineer, has been with Iacobus since its
creation. “We sell and maintain devices for disinfection, sterilization
and bio-decontamination,” says Węgier. “We were three engineers
with experience in servicing medical devices and systems for sterilization
and bio-decontamination, so we went into business. Our
main focus is now healthcare, pharmaceutical production, and food
production.”
Iacobus often performs bio-decontamination in hospitals in environments
like patient rooms and operating suites. Because hospital
beds are always in demand, the duration of room bio-decontamination
is crucial.
“The goal in hospitals is always to perform the bio-decontamination
as quickly as possible because the beds are always needed,”
says Węgier. “Ideally, we want to perform a full bio-decontamination
with vaporized hydrogen peroxide, but because time is so critical,
other types of decontamination are popular. We try to educate facility
managers on why vaporized hydrogen peroxide processes are so
effective, to help them choose the best method. There are decontamination
service providers on the market who offer aerosol disinfection
or ozone generators and similar systems. Unfortunately, the
brochures for these methods may oversell the actual results.”
Because Iacobus provides equipment to organizations that perform
regular decontamination, they also provide training in the use
of vH2O2 bio-decontamination equipment.
“The method used is important, especially in vaporized hydrogen
peroxide processes,” says Węgier. “With vaporized hydrogen
peroxide you use a high-concentration hydrogen peroxide solution.
The liquid is converted to the gas form. The heat required to vaporize
hydrogen peroxide is greater than that needed to vaporize water.
Air that contains vaporized hydrogen peroxide will condense sooner.
The condensate that is produced can have high parts per million of
vaporized H2O2 vapor. This may cause some damage to the surfaces,
so care must be taken.”
“This is one of the main advantages of doing vH2O2 decontamination
with the Vaisala HPP270 sensor. The sensor gives real-time
information so you know when the condensation point is close.”
Piotr Węgier, Iacobus Sp. z.o.o
One of the vapor generators Iacobus uses is the Cleamix portable
vapor generator, which comes equipped with Vaisala’s HPP270 vaporized
hydrogen peroxide probe. The probes provide various parameter
measurements, including: hydrogen peroxide vapor, temperature,
and humidity (as relative saturation and relative humidity), dew
point, and vapor pressure. The HPP270 probes can be integrated
with a vapor generator or control system.
“I learned about the Cleamix portable generators from a Vaisala
webinar,” says Węgier. “The product interested us due to the size
and design; it’s the size of a suitcase. Years of feedback from our customers
told us that the size of many vapor generators was the biggest
disadvantage in the process. It is time consuming to get a machine
and all necessary equipment from the storage location to the target
area for decontamination.
„The portability of the Cleamix vapor generator was a great benefit
and we find that the output is enough for most applications we
do. Often the areas that are being decontaminated are less than 100
m2. We were also very interested in the HPP270 sensor because it
provided possibilities for tests and calibrations of other sensors.”
Along with patient rooms, hospitals bio-decontaminate procedural
rooms and operating theatres. These rooms are often sites of
increased risk due to open wounds and body fluids. Today there is
an increasing global concern over multidrug-resistant organisms
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(MDROs), many of which can persist despite other types of cleaning,
such as routine terminal cleaning. Decontamination with vaporized
hydrogen peroxide in addition to terminal cleaning can significantly
reduce the risk of cross-contamination.
However, operating suites can have challenges in bio-decontamination
processes that involve vapor fumigation. “In operating
theatres there is sometimes the issue of not being able to turn off
the ventilation system,” says Węgier. “In one case, we had a room
which had routinely been disinfected with aerosol machines. We
were called to do a vH2O2 bio-decontamination when their aerosol
equipment broke down. During the process, we noticed that the ventilation
system was pulling the H2O2 vapor out of the room.
“This told us that the room may not have been properly decontaminated
before, because the ventilation would likely have pulled a lot
of the airborne aerosolized disinfectant out of the room. The Vaisala
HPP270 sensor, with its real-time measurements, showed us what
was happening during decontamination and allowed us to identity
the issue.”
The coronavirus pandemic initiated stricter disinfection and
decontamination protocols to stop the transmission of COVID-19
between patients in hospitals. With the COVID-19 pandemic, as
well as increasing anti-microbial resistance in other pathogens,
bio-decontamination that is streamlined and effective is becoming
critical for public safety. Vaporized hydrogen peroxide systems that
are equipped with real-time sensors can efficiently safeguard public
areas where human health is most at risk.
“Since the pandemic began, we’ve seen customers using their
vaporized hydrogen peroxide systems every day, even several times
per day,” says Węgier. “Time was always a major challenge in decontamination,
but now it’s even more important to decontaminate effectively
and quickly.
“This year we saw outbreaks in hospitals where all patients on a
ward were positive for coronavirus. In these cases, the entire ward
had to be decontaminated as quickly as possible. Having our portable
vapor generators with the Vaisala probe helped us make these
wards safer for personnel and patients.”
October 2023
Dear cleanroom professionals ,
We have known for some time that
Germany is not a pony farm. There are
many reasons for this. These include,
in particular, constantly tightened
specifications and legal regulations.
This is the subject of our cover story in
the German newsletter. The cover story
of the English newsletter is also about the
health sector. Other interesting articles
deal with the following topics, among
others:
> Safeguarding hospitals and healthcare
centers with vaporized hydrogen
peroxide
> Vial filling: Integrated line concept
> Cyto-Facto Inc.: Advancing
cell & gene therapies, providing
the promise of health
> Receiving MHRA approval
> Winning two of this year’s German
Packaging Awards
> Syntegon at CPHI Barcelona: New
solutions for small and micro batches
> High-End Humidity and Temperature
Sensor for Highest Demands
> Long Lasting Labeling Solution for
Laboratory Chair Manufacturer
> Hygiene with precision
With kind regards
Reinhold Schuster
Vaisala GmbH
Rheinwerkallee 2
D 53227 Bonn
Telefon: +49 228 249710
Telefax: +49 228 2497111
eMail: vertrieb@vaisala.com
Internet: http://www.vaisala.de
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page 3/28

Alcami’s new ARF isolator line is up and running, allowing the company to more than double
the daily production volume in Charleston.
Vial filling: Integrated line
concept from Syntegon
for CDMO Alcami
Autor: Stefan Schuh
Success is a real pacemaker: once it manifests itself as a major milestone like a portfolio expansion or a sales target, the
search for the next growth opportunity has already begun. The US-based company Alcami Corporation has done so time
and again. As a successful CDMO for the pharmaceutical and biotech industries, Alcami has confirmed its market position
through constant adaptations and innovations. One of the latest saw Syntegon support the company with a flexible turnkey
vial filling line for increased output.
675,000 square feet is a lot of space – enough to build a strong presence across North America. The impressive
number represents the total area operated by the Alcami Corporation, a major pharma and biopharma
CDMO. With its headquarters in Wilmington, North Carolina, the company runs facilities across
the country, including scientific campuses in Charleston, South Carolina, Research Triangle Park, North
Carolina, St. Louis, Missouri, and multiple locations near Boston Massachusetts. The sites provide the
much-needed flexibility to serve pharmaceutical and biotech companies of all sizes.
The latter are as diverse as Alcami’s vast network and related services: from customized solutions for
analytical development to clinical and commercial sterile fill-finish and oral solid dosage manufacturing,
the CDMO covers a wealth of steps along the pharmaceutical value chain. Its comprehensive portfolio
makes it one of the country’s few standalone full contract service providers, including packaging, microbiology,
environmental monitoring, and pharmaceutical support services.
Pushing the boundaries
Stefan Schuh
This strong market position didn’t come overnight: continuous portfolio expansions and a growing domestic
presence have strongly contributed to the corporation’s current success – and keep the company
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The line comes with proven isolator technology from Syntegon,
which effectively separates production areas and personnel, thus
contributing to the highest hygiene and safety standards.
As the line’s centerpiece, the filling and closing platform ARF
offers a versatile solution on a smaller footprint. For Alcami, the
major benefit of the ARF is the machine’s format flexibility.
busy in pushing its own boundaries. For over 40 years, Alcami has
taken pride in advancing products for its customers. This has led to
steady growth and increased demand, requiring a significant expansion
of their vial filling capacities for injectable medicines.
Alcami typically provides sterile filling operations for liquid
and lyophilized products for a broad range of customers in a variety
of containers, including 1 to 3 milliliter prefilled syringes and
2 to 50 milliliter vials. While the two campuses in the Carolinas
provide redundancy and additional capacity, the Charleston site
required additional capacity and scale to support its growing customer
base.
Keeping up with an increasing demand
“Our customers’ products support patients around the globe, and
we have supported client projects in over 35 countries to date. We
couldn’t have achieved this without continuously reinventing ourselves,”
says Sam Trimnal, Senior Director of Quality at Alcami.
“When we decided to expand our sterile vial filling capacities to keep
pace with demand, we were looking for a flexible line concept that
would allow us to easily switch between our broad format range of 2
to 50 milliliter vials and could be extended by further format ranges
upon customer requests.”
Expectations were high, since customers demand fill-finish
operations of the highest quality. For Alcami, this not only meant
state-of-the-art equipment, but a solution that would integrate liquid
filling and lyophilization technology in one line. Moreover, the
entire set-up required latest isolator technology for the highest product
and operator safety. Besides producing high-quality injectable
drugs, meeting global regulatory standards such as EU GMP Annex
1 is a key pillar of Alcami’s manufacturing strategy. “We knew this
would pose a considerable challenge to any equipment provider,
since we were looking for an especially high level of flexibility and
regulatory compliance,” Sam Trimnal explains. “But we also knew
there is a company in the market with a great reputation and a unique
approach to designing their lines. We decided to embark on that
demanding journey with them.”
Support like no other
That partner goes by the name of Syntegon, which has specialized in
packaging and processing technology with a proven track record for
comprehensive expertise in both sterile filling and isolator technology.
The strong global presence of more than 30 locations makes it an
exceptionally agile partner. This also showed in the cooperation with
Alcami: “It was only logical to turn to a company that could deliver
in terms of format flexibility and isolator expertise, while providing
on-site support thanks to US-based field service technicians,” Tom
Merola, Director Engineering & Maintenance at Alcami points out.
Alcami opted for a complete sterile vial filling line with isolator
technology from Syntegon. The solution consists of an ARF filling
machine with peristaltic pump filling technology and seven different
formats for maximum flexibility, as well as integrated lyophilization
and VRT capping technology. An HQL sterilization tunnel as well as
upstream and downstream cleaning machines ensure the highest
product safety.
As the line’s centerpiece, the filling and closing platform ARF offers
a versatile solution for industrial production of pharmaceutical
liquids in vials on a smaller footprint. For Alcami, the major benefit
of the ARF is the machine’s format flexibility. The latter allows to
easily switch between seven vial sizes and thus accommodates the
CDMO’s changing fill-finish requirements. Single-use filling components
contribute to the machine’s flexibility. Optional 100 percent
in-process control (IPC) adds to safe and reliable results. “Whichever
product or vial size – the ARF enables us to fill different customer
products safely, reliably, and easily. We can react to requests faster
and implement an increased number of customer projects”, Tom
Merola explains.
Safety at all times
Since safe processes are crucial for Alcami, the line comes with proven
isolator technology from Syntegon. The barrier system effectively
separates production areas and personnel, thus contributing
to maintaining the highest hygiene and safety standards. “Our cus-
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tomers’ portfolios include products that require utmost protection
– and so do our operators. Thanks to Syntegon’s uniquely designed
isolators, we make sure our staff is always safe,” Sam Trimnal says. To
this effect, Alcami’s new isolator comprises modern air management
and decontamination technology, as well as peripheral systems such
as airlocks, transfer equipment and wireless glove testing.
Before entering the ARF, the containers pass through an RRN
internal cleaning machine for low and medium outputs. Dedicated
stainless steel pipes connect its cleaning stations to the cleaning
media, leading to a hose-free cleaning area with reduced particle
generation. The vials with their particle-free interior are now transferred
to the HQL tunnel, which takes care of sterilization and depyrogenation
via dry heat. Following filling and capping, a RAN external
cleaning machine cleans the vials’ external surface. The design
ensures that the vials’ oversealed caps are protected throughout the
entire process, maintaining the integrity of the delicate products inside
the containers.
Teamwork in Charleston
Despite its complexity and scale, the line was installed smoothly.
“During the Covid-19 pandemic, we had to carry out many project
steps virtually. At the same time, the U.S. field service staff provided
excellent on-site support, when needed. Thanks to Syntegon’s ‘one
face to the customer’ approach and a dedicated project lead, everything
from the initial quote to the final installation worked out the
way we had planned. The good cooperation and coordination between
the teams were our secret to success – Syntegon knows how
to do this and provided the exact solution we needed”, says Tom
Merola.
“Syntegon really lived up to their reputation: they delivered an
excellent turnkey line including both filling and isolator technology
with a small footprint from a single source”, Sam Trimnal adds. So far,
Tom Merola, Director Engineering & Maintenance at Alcami, and Marc
Wilhelms, Business Development Director North America at Syntegon,
are very satisfied with the successful project.
the joint project has proven its worth. Alcami’s new ARF isolator line
is up and running, allowing the company to fill 2 ml vials at an output
of more than 6,000 vials per hour, and more than doubling the daily
production volume in Charleston while complementing four sterile
fill/finish lines in North Carolina. “This is a step change in Charleston
not only for us and our customers, but for patients out there as
well. As much as flexibility matters, so do long-term partnerships,
which we are happy to take to new heights time and again.”
Syntegon Technology GmbH
Blaufelder Straße 45
Telefon: +49 7951 4020
D 74654 Crailsheim
eMail: packaging-ph@syntegon.com
Internet: http://www.syntegon.com
Mit uns wirksam Kosten sparen! WZB - mehr als nur Reinraum
Dekontamination & Sterilisation
Herstellung & Mietservice
www.wzb-reinraum.de
Am Beckerwald 31 · 66583 Spiesen-Elversberg · Telefon +49 6821.7931158
Anzeige Reinraum-Online_quer_178x62 mm ohne Anschnitt
Freitag, 29. Oktober 2021 08:00:44
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Gerresheimer expands Technical Competence Center in Wackersdorf with the addition
of new Small Batch Production Sampling Area
Continuing the success story
Gerresheimer, an innovative system and solution provider and global partner for the pharma and biotech industry, is dedicating
even more space to small batch production. It has expanded the capacity of its small-batch production (SBP) area in
Wackersdorf by removing a section of the high-bay warehouse and converting it to a manufacturing space. The new Small
Batch Production Sampling Area Wackersdorf measures 700 square meters and will be used to manufacture pre-series
parts for assembly systems. The expansion is a further display of Gerresheimer’s far-reaching industrialization expertise in
the manufacture of containment solutions, drug delivery systems, and medical devices.
Gerresheimer has taken the next strategic step in its future by expanding
its Technical Competence Center and SBP facilities at the
Wackersdorf location for the third time in just five years. The new
700 square meters Small Batch Production Sampling Area is where
pre-series parts — samples used to set up manufacturing systems —
can be produced at series quality. An area that previously housed a
high-bay warehouse has been converted and equipped to meet the
latest production standards.
Pre-series parts in documented series quality
“This is our response to the changing project environment, which
involves a growing number of large-scale industrialization projects
with many different tools and large machinery,” says Holger Heining,
Head of Small Batch Production Gerresheimer Regensburg GmbH,
Wackersdorf. “For their high-volume assembly systems, industrialization
projects require a large quantity of pre-series parts in documented
series quality at an early stage of the project cycle. With our
new Small Batch Production Sampling Area, we can now meet these
demands and handle the rising number of large-scale industrialization
projects in the best possible manner.”
Automatic tool handling
Unlike development projects, industrialization projects require automatic
tool handling for high-volume manufacturing. The new area
reflects these new parameters, featuring 10 injection molding machines
with a clamping force of 175 to 420 metric tons.
A decade of small-batch production
Small-batch production at Wackersdorf in the Upper Palatinate region
of Germany started up exactly ten years ago. In 2013, the first
injection molding machine and automation solutions at the location
were installed in a small room. The setup proved to be resounding
success, kicking off a series of expansions to the facility. The first
parts of the warehouse were converted to clean room production
areas for injection molding and the assembly of plastic products in
2015. Three years later, in 2018, Gerresheimer invested an eight-digit
figure in the construction of new grade C and grade D clean rooms
and expanding its small-batch expertise to the glass sector.
In 2020 and 2021, the company made another eight-digit investment
at the Wackersdorf location, this time focusing on plastics.
By expanding the production area to 2,750 square meters in
total, Gerresheimer responded to the growing number of projects
that require smaller batches or a small quantity of pre-series products
for development, approval, and industrialization purposes.
The investment involved the construction of new office space but
predominantly focused on creating ISO class 7 and 8 clean room
facilities.
Wackersdorf now has 2,170 square meters of class 7 and 8 clean
room production space, a 220 square-meter controlled area, and a
360 square-meter clean room for pharmaceutical glass products that
meets GMP class C and D requirements.
Qualified staff wanted – over 40 new jobs created
in Wackersdorf
Gerresheimer is continuing on its growth trajectory, and the Wackersdorf
location is no exception. That’s why the highly motivated,
dynamic team is looking for new faces in the shape of experienced
experts, young talents, and trainees who are keen to use state-ofthe-art
approaches, systems, and methods to contribute to the success
of the projects and of the company as a whole. Gerresheimer
intends to create over 40 new jobs in Wackersdorf over the coming
months.
With a team of around 520 in Wackersdorf and a further 650
employees just 30 km away in Pfreimd, Gerresheimer is one of the
larger employers in the region. Overall, the MDAX-listed company
employs around 11,000 people worldwide.
The new Small Batch Production Sampling Area at the Gerresheimer
Technical Competence Center in Wackersdorf
Gerresheimer AG
D 40468 Düsseldorf
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Cyto-Facto Inc.:
Advancing cell &
gene therapies,
providing the
promise of health
Cyto-Facto Inc. Cell and Gene Therapy Facility hallway
In April 2023, Cyto-Facto Inc. (CF), a spin-off of the Foundation for
Biomedical Research and Innovation at Kobe, Japan, began manufacturing
gene and cell preparations to meet a worldwide growing
need for new treatments that leverage a patient’s immune system to
fight disease. One example is an emergent gene therapy like CAR-
T (Chimeric Antigen Receptor T-cell/CAR-T cell), which is showing
enormous promise in the treatment of lymphatic cancers. However,
robust process needs, including controlled, sterile environments,
make the manufacture of cell and gene therapies complex and costly.
With a solid track record in R&D and manufacturing investigational
and commercial products, Cyto-Facto Inc. has long experience
in compliance with GMP (Good Manufacturing Practice), and
process development for gene and cell preparations. A large team of
accomplished personnel has allowed Cyto-Facto Inc. to begin developing
and producing life-saving drugs and treatments.
Cyto-Facto Inc. CEO and President Shin Kawamata has faith in
the competency of the company’s staff. „Because the raw materials
for cellular medicine are living organisms, sterility and standardization
are difficult to achieve, as is proper implementation of the
manufacturing process,” said Kawamata. “The need to maintain a
heavy-duty HVAC system and high costs are hurdles to commercialization
and industrialization. In addition, the initial stage requires
manual manufacturing methods, which must be performed by skilled
personnel.”
Compliance with Good Practices for GCTP
While conventional drug and medical device reviews focus on the
technical aspects of manufacturing and quality control, the regulations
regarding GCTP (Good Gene, Cellular, and Tissue-based Products
Manufacturing Practice - Source PMDA) require more specialized
knowledge of the biological properties of cells and tissues and
their therapeutic effects. Because GCTP products are individualized
therapies that utilize the cells and tissues of an organism, unlike conventional
small molecule-based drugs, clinical trials and reviews are
conducted on an individual basis, with stricter rules for the production
and management of products to ensure safety and efficacy.
CF implemented the Vaisala viewLinc continuous monitoring
system in their controlled environments to ensure compliance with
strict GCTP regulations. Since CF provides Cell Processing Centers
(CPCs) for clinical trials and commercial development, the company
needs to meet the requirements of each client, including the layout
of the equipment in the processing center and the items to be monitored.
The Vaisala viewLinc monitoring system can be configured with
wireless data loggers to flexibly accommodate layout changes. In addition,
the ability to use virtual servers and the ease-of-use of the
software interface are ideal for managing the complex CPCs. As a
sensor manufacturer, Vaisala also offers a wide array of measured
parameters, device connectivity options, and support services. With
audit trail and user administration features, the viewLinc software
is compliant with GxP and global regulations. Vaisala also supports
compliance with its GxP documentation package and comprehensive
IQOQ protocols.
Before the viewLinc monitoring system was installed, Cyto-
Facto Inc. conducted a preliminary radio signal test to verify that
viewLinc’s RFL100 data loggers’ wireless communication was fully
functional across CPCs in separate buildings. This initial demonstration
allowed for the AP10 network access points and wireless data
loggers to be properly positioned and the system was implemented
quickly.
Environmental Monitoring before viewLinc
Prior to the introduction of the Vaisala continuous monitoring system,
sensors without data logging capabilities sent environmental
data to a centralized monitoring system. However, this entailed the
risk of data loss in the event of a communication failure. In addition,
the old system required an on-premise server, supported by periodic
data backups and maintenance, which placed an extra burden
on staff. The monitoring system software only provided one level
of access privileges. Access privileges were granted only to specific
personnel who had received training, to limit the number of operators
and avoid errors and data modification. With Vaisala’s viewLinc
monitoring system, detailed user access permissions can be configured
at multiple levels to achieve highly secure operations with flexible
and lean staffing. Easy administration of user access rights also
supports GxP compliance.
Advantages of Vaisala Wireless Loggers:
No Communication Failures
Today Cyto-Facto has over one hundred Vaisala RF100 wireless
data loggers operational in its manufacturing and cell storage environments.
Because cell processing centers have small, controlled
environments, such as refrigerators, freezers, and CO2 incubators,
there were initial concerns about using wireless connectivity for
data loggers. However, the Vaisala VaiNet wireless technology uses a
uniquely powerful wireless platform based on LoRa modulation, and
the VaiNet data loggers have proved to be reliable.
Environmental data in controlled environments has implications
for manufacturing parameters and process control in the development
of gene and cellular preparations, so seamless data collection is
extremely helpful for ensuring quality. viewLinc is also used to cen-
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Multi-parameter RFL100 data logger with probe splitter
Mounted RFL100 monitoring data logger
tralize data from different areas, such as quality control and storage
facilities. The viewLinc View settings allow users to centrally display
the rooms through which the material passes and then trace the
temperature and humidity at the time of passage, as well as display
the conditions of the equipment and CPC at the time of production.
Cell standardization supported by QbD
Currently, Cyto-Facto Inc. is particularly focused on cell standardization.
The purpose is to clearly define rules and standards and to
ensure a stable supply of cells with guaranteed safety. Efforts to standardize
and automate the cell therapy field to develop new products
and efficient production models are a major milestone toward commercial
manufacturing. However, cell therapy manufacturing is difficult
to standardize and automate. One solution may be using a Quality
by Design (QbD) approach for in-process monitoring to ensure
mechanisms and procedures that ensure optimal quality are designed
into all processes. Another solution is advancing technologies.
„Cloud-based software is being developed to set up a good variation
of standards and automate them with in-process monitoring,
which will ensure quality and reduce costs. Digitalization will be the
trend of the future,” said Kawamata. „In the cell culture process, there
are many factors that affect the condition and quality of the cells.
For example, the type and concentration of the medium, temperature,
CO2 concentration, and cell density.
“QbD allows us to evaluate how these factors impact quality
and to find the ideal conditions, which also helps automate the cell
culture process. Real-time monitoring of high-precision measured
data and constant maintenance of optimal in-process environmental
conditions have great potential to contribute to the realization of
automation and mass production in the future.”
„Instead of using destructive testing for the final test, I would like
to build on the QbD concept, pioneering the use of technological innovations
to create in-process monitoring that can be automated
and the use of a system that collects data in the cloud.”
Shin Kawamata, CEO & President of Cyto-Facto Inc.
Cyto-Facto Inc. is currently working with several companies to develop
new, optimized systems. One example is the Application Messaging
Platform (AMP), a new GxP-compliant cloud service that fully
digitizes the cell manufacturing process, ensuring both quality and
cost benefits. AMP digitizes operations throughout the facility, from
the delivery of patient cells and raw materials to planning, cell processing,
analysis, review, and shipping. With real-time monitoring
and review, product safety and efficacy are ensured through the digitization
of all records of cell processing.
It also allows for integrated collection and monitoring of values
such as pH, glucose, lactate, and pH vs. glucose to model complex
cell manufacturing processes visually, easily, and flexibly. AMP is
also expected to be a major step forward in automation, as it can adjust
the overall manufacturing schedule and prevent missing or outof-date
raw materials through RFID (radio frequency identification).
Ecosystems that coexist with people, medicine, and society
From the viewpoint that the formation of new industries will lead
to the sustainable development of the Kobe Biomedical Innovation
Cluster, Cyto-Facto Inc. is leading the way not only within the scope
of cutting-edge medical care, but also as a role model in the community.
A core facility in the Biomedical Innovation Cluster, Cyto-Facto
is part of an experiment in building a comprehensive ecosystem that
includes education and community outreach.
„Through educational outreach activities at local schools and
participatory experiences such as projection mapping, we are providing
places where children can develop an interest in cells and learn
about cancer cells and CAR-T cells,” said Kawamata. “In this way, we
hope to deepen the local community‘s understanding of disease and
to create a system to live in harmony with the community. So, we are
working on creating and producing scripts for events and YouTube
distribution.”
The viewLinc monitoring system monitors temperature, humidity,
differential pressure, particulate and carbon dioxide in various
applications at Cyto-Facto, including safety cabinets, clean rooms,
storage facilities, incubators and more. In addition, the company
uses Vaisala sensors and transmitters to measure and monitor material
gas supply and residual pressure. Vaisala measurement technologies
and systems will continue to be a part of Cyto-Facto’s complex
cell and gene therapy operations, supporting advanced medicine
that use living cells that provide hope for new, life-saving drugs and
therapies.
Application Messaging Platform (AMP)
Vaisala GmbH
Rheinwerkallee 2
D 53227 Bonn
Phone: +49 228 249710
Fax: +49 228 2497111
email: vertrieb@vaisala.com
Internet: http://www.vaisala.de
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New plant in Germany is 40%
more energy efficient with
Siemens technology and services
– Pfizer’s new high containment production plant is one of the world’s
most modern and sustainable; uses 40% less energy for environmental
control than traditional facilities
– Special containment concept, monitored and controlled by Building
Services from the Siemens Xcelerator portfolio, boosts safety for
employees handling high-potency ingredients
– Siemens technology integrates building and production data via Desigo CC
Pharmaceutical company Pfizer has opened
a new high-containment manufacturing facility
in Freiburg, Germany, using technology
and services from Siemens to make it one of
the most modern and sustainable of its kind.
Potentially producing up to seven billion tablets
a year for more than 180 countries, the
plant uses an innovative containment concept
- monitored and controlled by Building
Services from Siemens Xcelerator portfolio
- which ensures employee safety and results
in a 40 percent reduction in energy use in its
environmental control system, compared to
a traditional facility.
Building management platform Desigo
CC is the technology backbone of the facility’s
smart building infrastructure, acting as
a central control center to integrate multiple
systems and devices, and automate processes.
This enables systems to communicate
Die neue High-Containment-Produktionsstätte von Pfizer in Freiburg.
and collaborate with each other, collecting
and visualizing data from both the production
process and the building in one place.
“All machines and processes are intelligently
networked using information and
communication technologies, which enables
the Pfizer plant in Freiburg to produce
more flexibly, faster and with less resource
consumption,” said Gunther Bechmann,
Senior Manager Operations Manufacturing,
Pfizer Freiburg. “The constructive cooperation
on this project has once again confirmed
and expanded the existing partnership
that the Pfizer plant has maintained with
Siemens for years.”
High containment plants are designed
to safely manufacture medications with
highly active ingredients, which require
handling with the greatest of care. At the
Pfizer plant, Building Services from Sie-
mens monitor and control a special containment
concept, bringing together multiple
disciplines including power distribution,
ventilation, air conditioning and heating. As
a result of this concept and its technology,
Pfizer can manufacture medications with
category Occupational Exposure Bands
Four (OEB4), with employees only requiring
protective clothing to OEB3 level. This creates
optimum production conditions, while
ensuring maximum safety for employees
and increasing efficiency.
“Our work with Pfizer on the new Freiburg
plant is an excellent demonstration of
how applying an intelligent mix of technology
and services can produce exactly the
right outcomes, even in a challenging industry
like pharmaceuticals, where speed, consistent
quality and safety are all non-negotiable,”
said Dave Hopping, CEO, Solutions
and Services, Siemens Smart Infrastructure.
“The result is a faster, more flexible and
competitive facility, and a benchmark in
ultra-modern, sustainable pharmaceutical
production.”
Combining Desigo CC with SIMATIC
WinCC - a scalable process visualization
system - enables production-related data
to be exchanged between the production
systems and the visualization system. Data
relevant to production from the building
management platform is transferred to the
supervisory control and data acquisition
(SCADA) system, while information from
other production systems can be fed into
Desigo CC and used for predictive control
functions in the building automation systems.
This connection allows building management
data to be used in the central management
system, and can be accessed at
any time from individual production areas.
Networking and visualizing data in this way
enables the production facility to consume
around 40 percent less energy than traditional
plants in its environmental control,
by intelligently controlling the air flow and
temperature requirements in individual zones.
Forming part of Siemens Xcelerator,
Building Services is a portfolio of onsite and
remote services which improve the operation
and maintenance of buildings, through
data-driven, outcome-based service programs.
Siemens Xcelerator is an open digital
business platform to accelerate digital transformation,
comprising a curated portfolio,
a partner ecosystem and a marketplace to
speed up value creation across industry,
buildings, grids and mobility.
Siemens AG
D 80333 München
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Receiving MHRA approval
– UK site now set for clinical production of adeno-associated virus (AAV) vectors for gene therapy
– Highly experienced team ready to support ATMP innovators at all stages
– Offering comprehensive range of services from early process and analytical development
through cGMP manufacturing for clinical trials
Rentschler Biopharma SE, a leading global contract development
and manufacturing organization (CDMO) for biopharmaceuticals,
including advanced therapy medicinal products (ATMPs), today announced
that it has received the cGMP Manufacturing Compliance
Certificate, following the successful inspection by the UK Medicines
& Healthcare Products Regulatory Agency (MHRA) at its UK site.
The ATMP business was announced in early 2021 and the facility is
located in the Cell and Gene Therapy Catapult’s Manufacturing Innovation
Centre in Stevenage.
Dr. Robert Panting, General Manager of Rentschler’s ATMP
business, said: “MHRA’s approval marks a major milestone for Rentschler
Biopharma, and we are excited to offer our services from process
and analytical development through cGMP manufacturing. Our
team is highly knowledgeable, bringing years of experience in the
field of AAV. We provide a tailored program for each client, in line
with their needs and stage of development, while working closely
with them to move projects forward as rapidly as possible. We are
thus continuing the Rentschler tradition of offering a truly clientcentric
approach with the ultimate goal of helping patients. With our
first clients already on board, we look forward to adding other exciting
programs soon.”
Dr. Christian Schetter, Chief Scientific Officer of Rentschler
Biopharma, commented: “Our contribution to improving the health
and quality of life of seriously ill patients, is made possible by continuously
expanding our expertise in the production of essential biopharmaceuticals.
By launching Rentschler’s ATMP business, we aim
to address an important gap in expertise and support for innovative,
early-stage cell and gene therapy programs. It is gratifying to achieve
this important milestone of MHRA approval, bringing us closer to
reaching our objective of supporting clients already from the earliest
stages of CMC development. We are continually looking to understand
not only current client needs but future ones as well, which is
how our ATMP offering came to fruition. We will continue to listen
to our clients to anticipate how we can improve our offering and collaborate
in advancing medicine to save lives, together.”
Following the successful MHRA inspection, Rentschler Biopharma’s
ATMP business can now offer its full range of services for the
clinical supply of AAV, including bioprocess and analytical development
through to cGMP manufacturing at their Stevenage facility in
the UK. The company works to be a true partner to entrepreneurial
players to enable them to transform their ideas into real products
with the potential to treat and even cure patients with serious and
life-threatening diseases.
Rentschler Biopharma SE
D 88471 Laupheim
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Winning two of this year’s
German Packaging Awards
This September, SÜDPACK is the proud recipient of two of the renowned German Packaging Awards. The film manufacturer
impressed the German Packaging Award’s jury of leading experts with a recyclable bag for cheese ripening in the “new
material” category and with a recyclable film concept for blister packaging for solid applications in the “sustainability/
recyclability” category. What the two solutions have in common is that they are both based
on recyclable mono-materials and stand out due to their greater material efficiency
and reduced carbon footprints. On September 13, the SÜDPACK and
SÜDPACK Medica teams accepted the two awards during the traditional
cer-emony in Berlin.
The two awards, which now join the
many that were proudly accepted before
them, add to SÜDPACK’s story of success. At the
same time, the manufacturer of high-performance films
has impressively underscored its role as a leader in technology
and innovation in the market. Valeska Haux, Vice President of Strategic
Marketing, is particularly pleased about that fact that “we were
able to also win over the expert jury with a recyclable blister concept
for the pharma-ceutical industry. After all, SÜDPACK is not just a
leader in sustainability with its pioneering packaging concepts in
the food industry, but also in the medical goods and pharmaceutical
industries.”
With the Tubular Bag PurePE …
SÜDPACK is setting standards in recyclability, material efficiency
and in the re-duction of carbon footprints. The polyethylene-based
concept, which has been certified with a recyclability of 96% by the
renowned Institute cyclos-HTP, is already established on the market.
Compared to conventional film structures, this innovative packaging
solution reduces resource consumption by 23% by using a
thinner film measuring 30 µm in thickness – all while maintaining
the same functionality as well as maximum process and packaging
reliability. What SÜDPACK has achieved is “nothing short of a packaging
revolution” in the cheese ripening industry by reducing the
car-bon footprint by -52 g CO2/m², or 19%. “These results could indeed
be of par-ticular interest to milk processors who operate internationally
and who are focusing more and more on sustainable
packaging concepts,” emphasized Valeska Haux. At the moment, the
film manufacturer is seeing an increasing demand for PE-based film
concepts, because these mono-structures are classi-fied as recyclable
in many countries.
“With our Tubular Bag PurePE, we have an ideal substitute for
conventional PA/PE structures because it maintains the same high
requirements for product protection and functionality. This covers
the individual barrier properties that are essential for cheese ripening,
the maturation process and puncture re-sistance.” Last but not
least, close cooperation with machine manufacturers ensures that
the packaging concept can be optimally processed on full and semiautomatic
packaging machines.
PharmaGuard – for added sustainability
when packaging solid applications
SÜDPACK Medica’s PP-based and recyclable film concept for blister
packaging has also already been launched on the market. The
base and lidding films pro-duced in an innovative coextrusion process
feature a groundbreaking array of characteristics, including
high transparency and barrier functionality. “What is worth particular
mention is the excellent water vapor barrier thanks to having PP
as the base material,” added Valeska Haux. The perfectly matched
films guarantee top sealing performance, which is reflected by maximum
process reliability and packaging quality.
A life cycle assessment conducted by Sphera has proven that
the packaging concept is associated with a greatly reduced climate
impact (in CO2-eq) of up to 47% as well as lower energy and water
consumption compared to other com-monly used PVC/PVdC and
aluminum blister solutions.
Recognition
With the 46th German Packaging Award ceremony, a total of 34 innovations
from Germany, England, the Netherlands and Austria were
distinguished this year. What particularly delighted the independent
jury was the “high quality, diversity and range of the submissions as
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well as the clear focus in the areas of sustainability, circular economy
and climate and environmental protection.”
The winners received their awards on September 13 in Berlin’s
Meistersaal located at Potsdamer Platz. For SÜDPACK and
SÜPACK Medica, teams came from the Application Technology,
Business Development, Sales and Sustainabil-ity departments.
PharmaGuard impressed the jury “with its use of PP as a suc-cessful
alternative to conventional, non-recyclable blister packaging,
making it a recyclable packaging solution. The very good shaping
of the cavities of the blis-ter and the balanced PP-based covering
film, which showed a clear functionali-ty, are particularly noteworthy
in this development.”
The jury’s statement for the Tubular Bag PurePE concept concluded
that it “succeeded in converting an existing PA/PE packaging
into a mono-solution through successfully selecting and combining
innovative granulates, whilst at the same time ensuring the
functional barrier for cheese ripening as well as puncture resistance
required for this product. On top of this, the material reduction
of 23% compared to conventional cheese maturing bags was
impressive.”
SÜDPACK Verpackungen GmbH & Co. KG
D 88416 Ochsenhausen
Identified as best-in-class CDMO in global biopharmaceutical
aseptic fill-and-finish services
Earning Frost & Sullivan’s Customer
Value Award for the third time
We have been awarded the Frost &
Sullivan’s 2023 Global Customer Value
Leadership Award in the aseptic filland-finish
market for the high performance
for our customers. The award,
presented annually by the international
growth strategy consulting firm,
focuses on both business and customer
impact along with industry status
and trends in the market. In previous
years we were awarded for our Customer
Value Leadership and for our Customer
Service Leadership.
Best practices in operational
efficiency and customer processes
Frost & Sullivan recognizes the companies that offer products or
services customers find superior for the overall price, performance,
and quality. The firm applies a rigorous analytical process to evaluate
multiple nominees for each award category before determining
the final recipient. The process involves a detailed evaluation of best
practices criteria across the two dimensions – business and customer
– for each nominated company.
Vetter’s core service offerings include drug product development,
clinical and commercial aseptic filling, device assembly and
secondary packaging. The award details our consistent and successful
efforts to put the customer at the center of our operations.
Unmatched customer service experience
In response to the announcement, Frost & Sullivan’s Senior Industry
Analyst Surbhi Gupta said, “Vetter
offers highly specialized, state-of-theart
parenteral development and manufacturing
expertise for the entire
life cycle, from clinical development
to commercial production and packaging.
Through unwavering dedication
to delivering the highest quality products
and services and their exceptional
knowledge and expertise, they
strive to ensure their customers receive
the best possible services.”
Recognition of strong
financial performance
Additionally, Frost & Sullivan’s Best Practices Research Analyst
Pavel Zhebrouski remarked, “In 2021, we recognized Vetter for its
business and customer impact, and we remain impressed with the
continuous innovation and sustained leadership. Vetter uniquely leverages
its expertise to meet its customers’ needs, particularly the
growing transition to injectables.”
Vetter Managing Director Peter Soelkner is proud of the industry
recognition: “We always make our best efforts to provide customers
with qualities that are highlighted in this prestigious award. We leverage
our seven decades of experience and over 6,000 employees
to do so.”
Managing Director fellow Thomas Otto emphasizes: “We graciously
acknowledge that this award shows we are on the right path,
and we are looking to continue this approach towards the future.”
Vetter Pharma International GmbH
D 88212 Ravensburg
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page 13/28

Thanks to their standardized and modular design, the Pharmatec SVP
process systems can be adapted to a wide range of production needs.
Syntegon at CPHI Barcelona:
New solutions for small and
micro batches
– Market launch: gloveless, Annex 1-compliant production cell Versynta microBatch
– Synexio: cloud-based software solution offers seamless data transparency
– Xelum feeder-blender module and TPR 200 Plus: the new way of continuous direct compression
At CPHI Barcelona 2023, Syntegon will showcase new developments
for the filling and processing of small and micro batches. Equipment
designed specifically for small batch sizes is in high demand not only
for research and development, but also for the commercial production
of liquid and solid pharmaceuticals. Visitors to booth 3S50 will
see two innovations from Syntegon: Versynta microBatchand the
TPR 200 Plus. In addition, the cloud-based software solution Synexio
will be connected to Versynta microBatch.
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The cloud-based software solution Synexio from Syntegon
enables the collection, evaluation, and visualization of machine
and production data.
and maintenance management at fixed prices. „For new machines,
we initially recommend level 4 from the seven available levels,“ Hein
explains. This includes all preventive maintenance work as well as
training.
The fully automated production cell Versynta
microBatch from Syntegon fills between 120 and
500 containers per hour with virtually no product loss.
Market launch: Versynta microBatch live on show
Following the first digital presentation of the new Versynta micro-
Batch at Achema 2022, the official market launch will follow at CPHI
Barcelona: “Pharmaceutical and biotech companies require increasingly
flexible equipment for new, highly effective drugs, including
new developments in cell and gene therapy, for ever smaller patient
groups,” says Klaus Ullherr, Senior Product Manager at Syntegon.
“Maximum product yield and fast changeovers are paramount, especially
for very small batches. We will demonstrate how the Versynta
microBatch meets these requirements live at our booth.”
The fully automated production cell, which already won the German
Packaging Award in 2022, fills between 120 and 500 syringes,
cartridges, and vials made of glass or plastic per hour with virtually
no product loss and with 100 percent in-process control. Five integrated
inline inspection systems ensure continuous process monitoring
and provide particular safety by inspecting tubs, stoppers, and
caps. Requirements of the new Annex 1 were also taken into account
during development. For example, the gloveless isolator with integrated
air management significantly reduces the risk of contamination.
Optional network cameras facilitate continuous remote production
monitoring in the isolator.
Synexio: demonstration and sneak preview
The cloud-based software solution Synexio is also on show at CPHI.
It enables the collection, evaluation, and visualization of machine
and production data. „In addition to the visualization of KPIs and
machine availability and the identification of concrete improvement
potential, visitors will get a first glimpse of the third Synexio package
called ‚Empower‘. It includes component monitoring, which we will
demonstrate using specific use cases,“ says Elisa Hein, Product Manager
Expert Services at Syntegon. Synexio is part of Syntegon‘s
Service Agreements, which form the basis for effective equipment
The new way of continuous direct compression
The trend towards small batches also accounts for the production
of solid oral dosage forms. The Xelum platform offers continuous
solutions, from fluid bed granulation to direct compression. In both
cases, the same feeder-blender module can be used. In the configuration
shown at the booth, the module doses and mixes individual
packages, so-called X-keys. They ensure easy traceability and precise
dosing, even and especially for active ingredients of less than 1%.
Losses caused by starting and stopping are eliminated. The packages
are continuously fed into the TPR 200 Plus tablet press, which enables
efficient and user-friendly downstream processing. It features
a light containment concept with dust-tight machine protection up
to OEB 3. With the APD feeder, including automatically adjustable
powder infeed in the filling shoe and the APD software, manufacturers
can determine the optimum parameters for the formulation
feed into the die.
SVP process systems: maximum flexibility
Versatility is a key characteristic of Syntegon’s portfolio for liquid
pharmaceuticals. This includes the Pharmatec SVP process systems
for the formulation of small-volume liquid pharmaceuticals in batch
sizes from 13 to 3,000 liters, which will be displayed as 3D model
at CPHI Barcelona. Thanks to their standardized modular design,
the process systems can be adapted to a wide range of production
needs. With the latest addition to its portfolio – the highly modular,
fully automated SVP Essential – Syntegon offers pharmaceutical
manufacturers a cost-effective alternative with maximum flexibility
and short delivery times.
Syntegon Technology GmbH
Blaufelder Straße 45
D 74654 Crailsheim
Telefon: +49 7951 4020
eMail: packaging-ph@syntegon.com
Internet: http://www.syntegon.com
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page 15/28

Numerous innovations and further developments will also be presented in the deburring tools
area, for example the world’s first chamfering cutter with a V-shaped cutting edge that fully
excludes the occurrence of any secondary burrs. (Image source: Kempf)
5th Leading Trade Fair for Deburring Technology and Precision Surface
Finishing 10 to 12 October 2023 at the Karlsruhe Exhibition Centre in Germany
DeburringEXPO – New Solutions
and Know-How for Efficient
and Sustainable Deburring and
Surface Finishing
The deburring and surface finishing sector will meet again at DeburringEXPO at the Karlsruhe Exhibition Centre from the
10th through the 12th of October, 2023. Market and technology leaders, hidden champions, start-ups and research institutes
will present innovative and further developed solutions and services for current and future challenges in these quality
and cost-relevant manufacturing steps. The internationally unique spectrum of exhibitor offerings is rounded out with an
attractive supplementary programme including theme parks and a bilingual expert forum.
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The exhibitors will not only present various innovative solutions for
automated deburring – a special show area will also be dedicated
to this topic. (Image source: Botzian & Kirch GmbH)
The focal points of the three-day, integrated expert forum with a total
of 23 simultaneously interpreted presentations (German English)
include fundamentals, approaches to process and cost optimisation and
reports on best practice applications and current trends, as well as on
content provided by the theme parks. (Image source: fairXperts)
Manufacturing companies are currently facing major challenges that
will have to be mastered in order to remain competitive. A somewhat
lower priority is often assigned to production steps such as deburring,
edge rounding, component cleaning and surface finishing – unjustifiably
so, because enormous potential is available for optimisation in
these production processes. As the only international information
and procurement platform for these disciplines, DeburringEXPO
identifies opportunities targeted at improvement, streamlining and
enhanced resource efficiency in the relevant processes for investment
decision-makers, developers, design engineers and technical
purchasing agents, as well as manufacturing and production managers.
“This is reflected on the one hand by the numerous innovations
and further developments presented by the exhibitors at the leading
trade fair for deburring technologies and precision surface finishing.
Furthermore, solutions are also provided for dealing with the current
shortage of skilled personnel,” reports Hartmut Herdin, managing
director of private trade fair promoters fairXperts GmbH & Co. KG.
“On the other hand, the supplementary programme with its various
theme parks and the expert forum is also geared towards offering
companies inspiration and suggestions for optimising processes, reducing
costs and increasing sustainability.”
Innovations and Further Developments for All Applications
Whether market and technology leaders, hidden champions, startups
or research institutes are involved – exhibitors traditionally take
advantage of DeburringEXPO to premiere innovations and further
developments to its expert audience. These include world’s firsts
such as a self-learning deburring robots for toothed parts and the
first chamfering cutter with a V-shaped cutting edge, which prevents
secondary burrs and thus the need for additional, downstream deburring
processes. New systems and methods for fully automated
deburring and cleaning of components in a single process – using
high-pressure water jet techniques as well as ultrasound or dry processes
with CO2 granulate – will also be presented. New and further
developed products, technologies, processes and services in the
field of micromachining, as well as for energy and resource-efficient
production of application-oriented surfaces, is also facilitating optimisation
targeted at boosting competitiveness.
Theme Parks Covering Aspects with Relevance for Competition
The three theme parks at this year’s DeburringEXPO also provide
inspiration for mastering current and future challenges. For example,
the theme park for “Quality Assurance in the Deburring Process”
provides targeted information on various measuring methods, as
well as their strengths and limitations, in order to verify compliance
with ever stricter specifications in the areas of deburring, edge rounding
and surface finishing. The special show on “Automated Deburring”
presents the most up-to-date options for automated polishing,
grinding and deburring of components with robots, which also
plays a role in confronting the current shortage of skilled personnel.
Whether before or after deburring, technical cleanliness in accordance
with the specified requirements is an essential prerequisite
for the quality of downstream processes, and thus for high-quality
components as well. Corresponding methods and processes will be
presented in the “Cleaning After Deburring” theme park.
Bilingual Expert Forum – Knowledge, Trends and Best Practice
Applications
“As a supplement to the exhibitors’ cross-technology, multi-material
and inter-industry spectrum of solutions, DeburringEXPO ensures
an effective transfer of knowledge at the integrated, three-day expert
forum,” explains Hartmut Herdin. The programme, featuring
a total of 23 simultaneously interpreted presentations (German
English) by experts from industry and science, is divided into five
thematic blocks: “mechanical deburring”, “quality assurance”, “automated
deburring with industrial robots”, “cleaning after deburring”
and “non-mechanical deburring”. Presentation focal points include
fundamentals, approaches to process and cost optimisation, reports
on best practice applications and current trends. Trade fair visitors
are admitted free of charge and will also receive a free copy of the
updated and expanded brochure entitled “Basic Knowledge in Deburring
Technology” in German and English.
Further information, the entire exhibition portfolio and the
complete agenda for the expert forum, as well as the provisional exhibitor
list, can be found at www.deburring-expo.de.
fairXperts GmbH & Co. KG
D 72639 Neuffen
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Romaco at PACK EXPO Las Vegas
The new TPR 25 Pilot tablet coater
The new TPR 25 Pilot tablet coater from Romaco Tecpharm will be unveiled to trade visitors at this year’s PACK EXPO Las
Vegas. Romaco, the one stop solutions supplier for processing and packaging, will also be showing the PC 4350 high speed
continuous motion cartoner from Romaco Promatic and the smart KTP 1X R&D tablet press from Romaco Kilian.
Romaco will take advantage of this year’s PACK EXPO Las Vegas to
present an exclusive selection of its processing and packaging technologies.
The launch of the TPR 25 Pilot tablet coater underlines the
one stop solutions supplier’s expertise in laboratory applications.
From powder to pallet, the pharmaceutical machinery manufacturer
has the right solution for every process step – either standalone or
as an integrated line. Thereby, Romaco combines sustainability with
cost efficiency: the energy, material and space savings achieved by
Romaco machines reduce not only the end customer’s manufacturing
costs but also their equipment’s carbon footprint.
TPR 25 Pilot mobile tablet coater from Romaco Tecpharm for
batch sizes from 5 to 100 percent
Romaco Tecpharm is expanding its Optima product family with the
TPR 25 Pilot mobile tablet coater. All inlet and exhaust airflow systems
required for the coating process have been integrated into this
compact pilot-scale unit for simple plug & play commissioning. 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 Tecpharm’s
patented Optima 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
Optima 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 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.
PC 4350 continuous motion cartoner from Romaco Promatic
with ophthalmic bottles feeding
The PC 4350 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
TPR 25 Pilot tablet coater from Romaco Tecpharm
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 machine can
also be configured for feeding ecotrays with vials placed upright. Depending
on the requirements, glass vials, tubes, strips, blisters, and
countless other products can likewise be packaged quickly and reliably.
The Promatic PC 4350 achieves a maximum output of 350 cartons
per minute. Its positive carton opening system means 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 –
an exciting first – 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
4350 can be flexibly integrated into the diverse packaging concepts
of the pharmaceutical, nutraceutical, cosmetics, food and chemical
industries.
KTP 1X R&D tablet press from Romaco Kilian with digital access
to research data worldwide – ready for Industry 4.0
The KTP 1X is the newest generation of Romaco Kilian’s R&D tablet
presses for laboratory use. This single-stroke press was designed as
an all-in-one instrument for research and development activities. It
is suitable for pressing mono-layer, bi-layer and triple-layer tablets
as well as tab-in-tab formats. Depending on the model, it achieves
compression forces of up to 80 kN with a maximum output of 1800
tablets per hour. This versatile R&D press enables the various tableting
parameters, such as compression force or the possible tableting
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speed, to be automatically determined. The smart measurement
system evaluates huge amounts of data in next to no time for this
purpose. The KTP 1X is moreover capable of simulating any standard
rotary press, making it much easier to conduct scale-up trials.
In addition to the production of clinical samples, the technology also
allows detailed troubleshooting and hence supports process optimization.
Thanks to the machine’s extremely good rigidity, the punch
position in particular can now be measured more precisely. This high
measuring accuracy goes hand in hand with extremely low product
consumption, which is why the KTP 1X is not only very accurate but
also cost-efficient and sustainable. Only a few test series are required
to obtain meaningful results because the compression studies are
highly automated. With its very small compaction area, the machine
has a small footprint and is quick and easy to clean – for even greater
time and energy savings. What’s more, the KTP 1X ships with a data
module that gives users access to raw measurement data worldwide
at any time, even when the tablet press is not in operation.
Romaco Group
D 76227 Karlsruhe
Cleanroom microbiology specialists to discuss and highlight the best EM solutions for
differing needs at key industry events
Adviseing on reducing risk
with EM in aseptic processing
Cherwell, specialists in cleanroom microbiology solutions for the
pharmaceutical, healthcare and related industries, will be available
at a number of aseptic processing focused events in September to
advise attendees on how they can reduce risk with environmental
monitoring (EM). Cherwell’s microbial EM experts will be present
at these events to discuss and highlight best practice and product
solutions for differing EM needs to ensure the safety and quality of
sterile medicinal products.
The Company will be exhibiting at three key events, these are
the PHSS Annual Conference in association with UCL Q3P 2023 (14
September), the Aseptic Processing Conference (18-19 September),
and the NHS QA - Quality Assurance and Technical Services Symposium
(QATS) (28-29 September). In addition to offering advice,
they will also be demonstrating a number of EM product solutions
on Cherwell’s exhibition stand at each of these events, and how they
can support contamination risk reduction in critical areas and processes
in line with GMP Annex 1 requirements.
Products available to view and discuss will include the new portable
BAMS real-time, airborne microbial monitor for continuous air
monitoring and instant alerts, particularly useful in GMP Grade A
environments. Rapid identification enables prompt actions and reduces
risk of potential contamination incidents. For active air sampling
applications in lower grade cleanrooms, Cherwell will demonstrate
the SAS hand held microbial air sampler range which offers
reliable and cost-efficient sampling for trend analyses.
High quality prepared culture media is also key for environmental
monitoring applications for regulatory compliance. Cherwell’s
Redipor® quality-assured prepared media range meets all needs
for this traditional, reliable monitoring technique. Offering poured
media plates, bottled media, broth bags, ampoules, and also tailored
solutions, Cherwell will discuss how they can match the specific requirements
of both organisation and facility.
Cherwell will also highlight its EM accessories. These include
Settle Plate stands offering a defined sample point and reducing the
risk of a spoilt sample; plus plate carriers to aid safe handling and
transportation, as well as efficient use of incubator space. SAS Daily
Heads remove the need for a validated, sterilisation process and
substitute this with a certificated sterile product which provides a
viable alternative in the quest to reduce risk of false positives.
“We find that attending events such as these is one of the best
ways for us to keep up to speed with the very latest industry information
on aseptic needs and best practices. We can learn from talks and
presentations, plus discussions with delegates,” said Thomas Parkhill,
Business Development Manager South, Cherwell. “It is also an
ideal opportunity for us to be able to share and discuss our findings
on good practice with our customers, and demonstrate how we and
our product solutions can best support them in their use of EM to
reduce risk in aseptic processing in line with Annex 1 requirements.”
Alongside its microbial environmental product range, Cherwell
also provides support in the area of risk reduction with EM through
its Delivering Knowledge platform, specific Annex 1 resources, and
by adopting a consultative sales approach that focuses on individual
applications and product needs.
Cherwell Laboratories Ltd
OX26 4XB BICESTER
United Kingdom
www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 10-2023
page 19/28

Process transparency and digital
intelligence are factors for more sustainability
The motan Group, Constance, is focusing its attention on minimizing energy consumption and the circular economy. At
Fakuma from 17th to 21st October 2023, in Friedrichshafen (Hall B1, Stand 1111), the materials management specialist will be
presenting a selection of its energy-efficient ancillaries tailored to this purpose, as well as a CO2 calculator for assessing the
carbon footprint when producing plastic parts. For processors in the medical and pharmaceutical industries, a completely
new product line will be presented.
„The energy data of the material have a massive influence on the
overall ecological balance of the manufactured products. Plastics
processors expect more transparency and standards here,“ explains
CEO Sandra Füllsack. By means of energy monitoring, it is possible
to record the energy consumption of each individual process step.
The CO2 footprint of each individual part can be calculated, and
the data is certified. This provides the processor with the basis for a
systematic optimisation of the energy consumption of his individual
production processes.
Process-safe and energy-saving drying
The material drying process is particularly energy intensive. In the
latest generation of LUXOR SG small-volume dry air dryers, motan
has incorporated the ecoPROTECT function as standard. Depending
on the unit size, the function reduces energy consumption by
10%. At the same time, the protective function ensures a secure and
reliable drying without overor under-drying. The mobile small dryers,
in which this process-safe technology has been combined with
state-of-the-art microprocessor control, are among the trade fair
highlights at the motan stand.
FDA-compliant material conveying and gravimetric dosing
and mixing
motan has designed the new METRO G med material loaders especially
for plastics processors in the medical and pharmaceutical industries.
The extensive family of loaders are based on the established
METRO G series of system loaders for plastic granulate and
meet all strict hygiene requirements according to FDA 21 CFR. Spe-
cial attention has been paid to process-safe use in all types of clean
room. Special filters with high-quality FDA compliant seals and electropolished
stainless steel surfaces ensure reliable, dust- and contaminationfree
operation. A highlight is the new membrane implosion
vacuum valve, which does not require compressed air.
The gravimetric batch dosing and mixing unit GRAVICOLOR 110
med is tailored to the same target group. Like the GRAVICOLOR 110
introduced earlier this year, motan developed this new FDA-compliant
version for flexible and reliable mixing and dosing in injection
moulding, blow moulding and extrusion applications. Both systems
can be seen on the exhibition stand. The dosing and mixing technology
is identical. Specially developed vertical slide valves dose and
mix up to four different components precisely and with the highest
recipe accuracy. The integrated and improved IntelliBlend analysis
function records the recipe, material and operating environment
and documents all process data. With the help of this function, the
user achieves continuous self-optimisation of the system and consequently
the best possible operating point with the highest recipe
accuracy and consistent, high product quality. Thanks to event-based
logging, all parameter changes are stored in a control report and
can be subsequently evaluated.
Promoting a holistic understanding of the process
Within the scope of the motan academy, companies can have their
personnel trained to such an extent that not only the technology
and function of individual units is understood, but also the entire
production process. Being able to set up and operate a machine is
important. Understanding how settings affect the entire process is
even more important. The basic and advanced seminars of the motan
academy teach users the interrelationships of material management
in theory and practice.
Plastic as a valuable material
In a functioning circular economy with high-quality recycling, material
handling plays a key role. To achieve this, motan focuses intensively
on the digitalisation of systems and the networking of production
processes. The avoidance of material or energy losses through
appropriately designed systems is just one aspect that the material
management specialist expresses with its slogan ‚Zero Loss‘. Continuously
developing processes and products and making them more
sustainable is part of motan‘s long-standing strategy. Fakuma, Europe‘s
largest plastics trade fair, is an important signal. This is where
the motan Group demonstrates how it is helping to shape the future
of plastics.
METRO G med – Medical material loaders for granulate (motan group)
motan holding gmbh
D 78467 Konstanz
www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 10-2023
page 20/28

Battery production in Europe takes off
The energy and transport transition is in full swing. Support programmes and new regulations in Europe, the USA and
especially China are fuelling a boom that has already clearly taken shape. The challenges are great, but so are the opportunities
– also for the suppliers represented at POWTECH.
„There are nine million bicycles in Beijing,“
sings musician Katie Melua since 2005 - and
she could now add: „and nine million electric
cars in China.“ With a total of over five million
new registrations in 2022, the nine million
threshold was already exceeded last summer.
And the trend is rapidly rising. Although government
subsidies for electric vehicles have
recently been cut even more in China than in
Germany, this will not stop the trend towards
electric cars. Buyers and manufacturers of
vehicles with internal combustion engines
are threatened with further trouble: while the
new Euro 7 emissions standard is still being debated in Germany and
Europe, China is demanding even stricter limits with regard to emissions
from July 2023 with the 6b standard. It would be a scoundrel to
think that the nation, which dominates the battery and thus the electric
car market, will make the approval of new internal combustion
vehicles, such as those offered by Western manufacturers, virtually
impossible.
This example highlights the current changes - and change hurts.
There is hardly any other area of the economy where this can be observed
as clearly as in the energy transformation: whether hydrogen,
building heating, electric mobility or speed limits - the discussion
about the best measures for a change in the energy and transport
sector towards climate neutrality is causing sentiment to run high.
And this could be just the beginning: More than 200 different energy
transformation technologies are currently in various stages of market
maturity. What they all have in common is that they are intended
to help replace fossil fuels in the energy sector. And: the vast majority
of them use climate-neutral electricity.
50 battery factories to be built in Europe
But there are enormous opportunities in this change. Companies
that actively participate in the energy transformation will profit.
Here, too, electromobility may serve as an example. In order to meet
the massively increasing demand for batteries for electric vehicles,
more than 50 battery factories are currently being planned in Europe
alone. Because the production of batteries and battery materials
is enormously demanding, plant and machine manufacturers are in
demand who can develop these complex production processes and
supply the equipment for them.
The market for electrically powered vehicles is also growing rapidly,
irrespective of stricter emission values, which in the long term
can hardly be achieved by vehicles with combustion engines: In
2022, the volume climbed by 50% to 425 billion US dollars compared
to 2021. In the same period, the demand for batteries has doubled.
And politicians are adding to the pressure: the „Net Zero Industry
Act“ proposed by the European Union in March 2023 aims to have
around 90% of the European Union‘s annual battery demand (550
GWh) met by European battery manufacturers by 2030. In the United
States, the Inflation Reduction Act provides billions of dollars
in subsidies to build supply chains for electric vehicles, batteries
© Michael Marais / Unsplash
and battery minerals. Between August 2022
and March 2023 alone, major electric vehicle
and battery manufacturers have announced
investments of at least $52 billion in North
America, 50% of which will be for battery
manufacturing, according to the IEA energy
agency.
Modern production technology in demand
The new battery producers in Europe and elsewhere
certainly have a chance to close the
gap on the dominant battery nation China.
After all, there is still a lot of potential for improvement in modern
production technology to manufacture more powerful batteries at
a lower price. Currently, alternatives to the lithium-ion battery are
being developed in the form of lithium iron phosphate and sodium
ion batteries, which have raw material and cost advantages. But there
is also great potential for efficiency in the production of battery materials:
mixing processes with a higher throughput and at the same
time higher mixing quality are only one of many detailed aspects.
And here, politics is also setting new framework conditions, such
as the new EU regulations that have been in effect since May 2023
and are intended to make the production, use and recycling of batteries
more environmentally friendly. According to these regulations,
at least 65% of all batteries must be recycled by 2025. The EU has set
a binding target of 90% for the recovery of the metals cobalt, nickel
and copper, which are essential for battery production. And the EU‘s
Boundary Compensation Mechanism (CBAM) - possibly the most
radical change yet for taxing greenhouse gas emissions - will also
include precursor metals for batteries, including nickel. These specifications
also offer opportunities - not only for recycling companies,
but also for suppliers of processes and machinery.
However, factory equipment - whether for the production of
batteries or their recycling - is so far often still piecemeal. Often the
proprietary manufacturing processes are planned down to the last
detail by the operators themselves, which leads to problems at the
interfaces between individual process steps, machines and their manufacturers.
In addition, there are hardly any plant engineering companies
that can build battery factories as EPC or EPCM contractors.
Another complicating factor is the high requirements not only with
regard to product quality but also operator protection: the materials
used, often in powder form, are toxic and flammable and must be
handled under hermetically sealed conditions (containment for hazard
potential OEB 4 or OEB 5).
The technologies for this are there - now it is a matter of clever
cooperation between the actors and the will to implement. For
example, it will be several years before the number of electric cars
in Germany grows from the current one million to nine million. But
„nine million electric bicycles“ is something we have already achieved
on the way to climate neutrality in 2022, after all.
NürnbergMesse GmbH
D 90471 Nürnberg
www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 10-2023
page 21/28

The HTS801 sensor supports highly accurate measurement of humidity and temperature
even under the most challenging conditions such as high humidity and chemical
exposure.
High-End Humidity and Temperature
Sensor for Highest Demands
The new HTS801 sees E+E Elektronik launch its most powerful humidity and temperature sensor for industrial applications
on the market. This versatile, high-end measuring device combines the Austrian sensor specialist‘s decades of experience
in the field of humidity measurement with the high quality demands of industrial metrology. The sensing probes of
the HTS801 incorporate a premium, heatable sensing element for accurate measurements, guaranteeing long-term stability
even under the most challenging conditions. Additional options such as a large colour display or plug-and-play probe
replacement using rapidX technology ensure user-friendly operation and easy maintenance.
Excellent Measuring Performance, Wide Range of Applications
The HTS801 is particularly well suited to use in applications with
high humidity and chemical exposure. It is based on the E+E sensing
element with monolithic structure. An integrated heater enables targeted
heating of the sensing element to prevent condensation and
its negative impacts on the measurement results. Depending on the
requirements, two type-specific operating modes are available for
selection:
– „Condensation Guard“ in case of a short-term risk
of condensation
– „High Humidity Guard“ for permanent exposure
to high humidity and condensing conditions
In addition to this, all HTS801 models have an Automatic ReCovery
(ARC) function. ARC removes chemical impurities and eliminates
possible drift effects through short-term intensive heating of the
sensing element.
Furthermore, the tried and trusted E+E sensor coating protects
the sensing element and its leads against corrosion or deposits. This
special coating extends the sensor‘s service life, ensuring
accurate measurement results and improved long-term stability in
harsh or corrosive environments.
Thanks to its wide operating range from -80 °C to 180 °C (-112 °F
to 356 °F) and 300 bar (4 351 psi), the HTS801 is suitable for a variety
of applications; for example, for monitoring drying processes, humidity
and temperature monitoring in fuel cell test benches, climate
chambers or high-humidity storage rooms to demanding measurement
tasks in meteorology and much more.
The rugged polycarbonate or stainless-steel enclosure, featuring
IP65 / NEMA 4X protection, supports easy mounting and maintenance
of the HTS801.
Plug-and-Play Probe Exchange
The HTS801 offers the option of smart, pluggable sensing probes.
Every HTS801 rapidX smart probe can be exchanged without configuration,
adjustment or calibration following the plug-and-play
principle. The specific parameters are stored directly in the probe
and are transmitted to the sensor when the probe is plugged in. This
avoids downtime and costs if a probe needs to be replaced due to
damage or for recalibration.
HTS801 humidity and temperature sensor for demanding industrial
applications. (Photo: E+E Elektronik Ges.m.b.H.)
HTS801 humidity and temperature sensor with stainless steel enclosure.
(Photo: E+E Elektronik Ges.m.b.H.)
www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 10-2023
page 22/28

Display with Data Logging and Diagnostics Function
The HTS801 is optionally available with a 3.5“ TFT colour display.
This allows up to four physical quantities to be displayed simultaneously
and monitored locally. The integrated data logging function
stores up to 20 000 measured values per measurand. The values can
be visualised on the display or downloaded using the USB service
interface. Thanks to the on-board diagnostics function, the operating
status of the HTS801 can be checked directly on the device.
Interfaces and Configuration
The measured data is available at two freely scalable analogue outputs,
RS485 (Modbus RTU) or Ethernet PoE (Modbus TCP) interface,
and at two alarm (relay) outputs. This enables flexible integration
of the sensor into customer‘s own data acquisition systems.
The HTS801 can be configured via the USB port using the free
PCS10 configuration software or directly on the device using the
display and push-buttons.
E+E Elektronik Ges.m.b.H.
Langwiesen 7
A 4209 Engerwitzdorf
Telefon: +43 7235 6050
Telefax: +43 7235 6058
eMail: info@epluse.com
Internet: http://www.epluse.com
Reliable and Chemical-Restistant
Long Lasting Labeling Solution
for Laboratory Chair Manufacturer
Schreiner ProTech‘s PolyScript label can master a whole range of challenges - especially when it comes to the special conditions
in the laboratory sector. Recently, Cramer Inc., a Kansas City-based manufacturer of laboratory chairs, has also been
relying on these identification labels from Schreiner.
The PolyScript label permanently and reliably
identifies Cramer Inc. laboratory chairs.
Laboratory equipment, including chairs, must be robust, disinfectable, gapless, and
antistatic. Cramer, which has specialized in special-purpose seating for nearly 90
years, had been consistently encountering problems caused by the labels on its
high-tech Helix® portfolio of lab chairs. Often, the labels either would fail to adhere
properly – sometimes coming off as early as the assembly process – or vital printed
information would be rendered illegible by the aggressive chemical cleaning agents
common to lab settings. Without precise, reliable information pertaining to specific
production batches, Cramer found it difficult to provide adequate technical aftersales
support – a particularly concerning issue considering the company’s 15-year
product warranties.
Last year, Cramer and its long-time contract manufacturer, Michigan-based
Nuvar Inc., adopted Schreiner ProTech’s Color Laser Films (CLFs), which reliably
adhered to the chair frames and resisted the healthcare sector’s strict cleaning procedures.
Unfortunately, the corresponding laser printer series was unexpectedly discontinued.
A quick and uncomplicated solution was required. Pivoting, Schreiner
ProTech suggested thermal transfer ribbon (TTR) printing, since the company had
successfully employed similar solutions in the rugged industrial sectors it historically
serves. In addition to providing exemplary ahdesion and withstanding harsh cleaning
agents, the TTR-printed PolyScript labels could be printed with white lettering
on a black background – a design perk for Cramer’s predominantly black chairs. “We
almost exclusively manufacture black chairs, and don’t want a large, white sticker to
take center stage on the back of the chair,” says Kyle Waggoner, Design Director for
Cramer Inc. “The new label is coordinated in every detail and blends well with our
holistic design initiatives for creating innovative and high-end laboratory seating
furniture.”
High-quality Helix® lab chairs equipped with Schreiner ProTech‘s durable Poly-
Script labels - a promising combination that benefits users.
Schreiner ProTech
D 85764 Oberschleissheim
www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 10-2023
page 23/28

Arburg exhibit at Fakuma 2023
Allrounder 520 A: Highly innovative
IML application for medical technology
– Innovative: In-mould labelling (IML) for centrifuge tubes creates added value
– Integrated: IML labels increase functionality of medical technology products
– In partnership: Joint project around high-performance electric machine
Arburg will be present at Fakuma 2023 with nine exhibits on Stand 3101 in Hall A3, plus ten additional machines on partner
stands. While in-mould labelling (IML) is standard for packaging products, this process is still rarely used in the medical industry.
Using centrifuge tubes with labels as an example, Arburg will be unveiling an innovative IML application with added
value for the pharmaceutical industry and medical technology.
Renowned partners KEBO (tooling), MCC/Verstraete (label), Beck
(automation) and Intravis (camera inspection) are involved in the
innovative joint IML project centred around an electric Allrounder
520 A in clean room design.
Functional integration using an IML label
IML labels enable functional integration in a single step with no
need for printing associated with rejects, for example, or further
downstream work steps. As a result, the production process is fast,
space-saving, cost-efficient and without any additional hygiene risk.
The intelligent linking of data is essential for smooth digital communication
between patients and doctors or home care applications.
Individual codes can be used to track data on processes, quality and
patients, for example, with 100 per cent traceability for each individual
part. The monitoring of temperature profiles or information
on recycling and warehouse management can also be implemented
with these labels.
High-performance electric machines for medical technology
The exhibit, an electric Allrounder 520 A „Ultimate“ with 1,500 kN
clamping force, is designed for fast and demanding processes such
as thin-wall applications. The high-performance machine in clean
room design meets the requirements of class ISO 7. An 8-cavity
mould from KEBO is used to produce 15 millilitre tubes from PP. A
label applicator head from Beck is used to apply the labels, while optical
control is carried out via a camera system from Intravis. The servo-electric
drives of the injection moulding machine ensure precise
and reproducible mould positioning. With the exhibit, attention was
also paid to a low carbon footprint, energy efficiency and a compact
production cell.
Expert Talks at Fakuma
The project managers from Arburg, Beck, Intravis, Kebo and MCC
will explain the advantages and potential of IML products for medical
technology at two expert talks during the trade fair. These will
take place on Wednesday 18 and Thursday 19 October, both at 2 p.m.
in the “Schwarzwald” room, Conference Centre West.
Registration:
https://iml.mcclabel.com/en/expert-talks-at-fakuma2023.
Further information:
https://iml.mcclabel.com/en/medical-iml-at-fakuma
ARBURG GmbH + Co KG
D 72290 Loßburg
An innovative application for medical technology is demonstrated by an electric Allrounder 520 A Ultimate. The high-performance machine will be
producing IML centrifuge tubes at Fakuma 2023 as part of a joint project. (Photo: ARBURG)
www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 10-2023
page 24/28

Ingelfingen-based valve specialist GEMÜ is launching two new solutions for
connecting single-use multi-port valve blocks.
New solution for connecting
multi-port valve blocks
The first solution means that it is now possible
to control the pneumatic locking of the
valve block via locking cylinders thanks to a
valve block sunk into the skid surface. The
second solution consists of using a valve
block placed onto the skid surface, where
the valve body is manually connected to the
actuator unit via a detachable hand lever.
This second type offers greater flexibility for
the spigot layout. The connection between
the actuator and the diaphragms welded
onto the valve block is created reliably wit-
hin a few seconds using the familiar clamping
principle of the GEMÜ SU40 SUMON-
DO. The blocks themselves are produced by
machining and can therefore be tailored to
each specific application.
There are several benefits to using single-use
technology: Eliminating the need for
conventional cleaning cycles and the associated
costs for power, cleaning media, waste
disposal and peripherals while increasing
protection against cross contamination
between different manufacturing drives.
It also minimises downtimes in factories,
which significantly improves the flexibility
and effectiveness of single-use solutions in
the medical and pharmaceutical technology
sectors in comparison with conventional
solutions. In addition, the use of single-use
technology reduces negative environmental
effects by eliminating energy-intensive
cleaning cycles.
Single-use multi-port valve block
with manual locking device
Single-use multi-port valve block
with pneumatic locking device
GEMÜ Gebr. Müller Apparatebau GmbH & Co. KG
D 74653 Ingelfingen
www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Ausgabe DE 05-2023 Seite 25/103

EasyCare in use by customers
Hygiene with precision
In order to ensure long-term durability and performance of the tableting tools, a pharmaceutical-chemical company has
opted for cleaning systems from the EasyCare range.
The demands placed on tableting tools are
continually increasing. “Our punches,
segments and dies must be able to withstand
enormous loads and be easy to replace
and clean according to high hygiene
standards,” explains Carmen Ackermann,
Senior Product Manager at Fette Compacting.
Companies that have been working with
Fette Compacting for a long time know that the
tableting tools from the company’s own production
in Schwarzenbek are built precisely for such demands.
However, it is also crucial how the tools are maintained throughout
their entire product life cycle.
One example: an international pharmaceutical and chemicals
producer uses tablet presses and tableting tools from Fette Compacting
at its main site. A main cleaning process is scheduled once a
week for the machines and tools. In the past, this involved cleaning
the tableting tools with the help of stock washers and, if necessary,
manually. Trained technical supervisors then had to check the setup
and cleaning steps individually. This was an altogether time-consuming
process for which Fette Compacting, together with cooperation
partners, has developed an efficient alternative called EasyCare.
Handling and care go hand in hand
EasyCare is a modular handling and care system for tableting tools.
An important element is represented by the tool box system patented
according to the TRI.EASY design principle, which allows punches,
segments and dies to be transported, stored and cleaned in a
protected manner. The trays of the cases fit exactly into a fully-automatic
cleaning system of our partner ARUNA. In this so-called surge
cleaning process, the tools are cleaned with cleaning and corrosion
protection agents from Borer Chemie without leaving any residues.
In addition, there is the option of automatic polishing, for which a
machine from our partner nortec is available. Furthermore, the tool
management system PartSite® enables simple system-supported
management of tools and machine parts. With these Good Manufacturing
Practice (GMP)- compliant-components, Fette Compacting
offers a complete solution for the safe and efficient handling of
tableting tools.
Due to the general switch to fully-automatic cleaning in various
areas of production, the pharmaceutical company decided to purchase
two cleaning machines. During a visit to Schwarzenbek, the
demonstration machine was thoroughly convincing. “Above all, the
precise coordination between ARUNA and Fette Compacting in the
design of the wash racks and the joint development of new components
with optimized cleanability were decisive factors for the customer,”
says Carmen Ackermann. “In the future, they want to have
practically all machine parts reprocessed in the cleaning systems –
even those that are currently still cleaned manually.”
Shorter and easier cleaning
ARUNA’s cleaning machines significantly reduce the cleaning time of
machine parts and tableting tools while also saving space.
Following conclusion of the validation phase, the new cleaning systems
were commissioned in early 2023. Several test runs had already
been carried out to determine the recipe for punches and segments.
The company expects that surge cleaning will shorten cleaning
times and reduce the number of cleaning steps. The large loading
volume and two-level wash racks offered by the machines significantly
reduce the number of loading cycles.
The producer of solid formulations is also testing the trays for
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segments and bellows, whereby operators receive technical support
from Fette Compacting.
“Whether maintenance, troubleshooting, software updates or
mechanical changes: service technicians from our partner company
provide support at every step, training our customers’ staff and
helping to optimize the cleaning process,” emphasizes Carmen
Ackermann. And even more progress is in the pipeline: transport
carts that can be lowered, thereby facilitating the loading process for
employees are in the design phase at ARUNA. New storage racks
could soon significantly reduce the space required for wash racks
and transport carts. And thanks to EasyCare, the need for wash racks
is already reduced, saving further space.
Fette Compacting GmbH
D 21493 Schwarzenbeck
Clean Latches
With parts to which hardly any dirt clings and that can be cleaned in place, there is less need to spend time and money on
cleaning and cleaning media. This also translates into an increase in reliability for the production systems. With the latches
GN 1150 in Hygienic Design, Ganter provides support for the machine and system cleaning concept known as clean in place,
or CIP for short.
Even outside of the industries that must traditionally comply with
high standards of hygiene, the concept of clean in place, meaning
the cleaning of components while still fully installed, is becoming
ever more common. The idea is that if systems, fixtures or machines
can be cleaned more easily and more quickly, this lowers the
operating expenses in particular. This is why Ganter is continuously
expanding its portfolio of standard parts in Hygienic Design (HD).
The most recent HD standard part, GN 1150, refers to cam latches
of stainless steel with special FDA-compliant seals of EPDM and
TPU. Thanks to these seals, the latches have no dead spaces where
dirt could collect. When the latch arm is turned by 90 degrees,
its beveled surfaces produce a tension that reliably presses covers,
hatches, doors or covers against their opposing element (frame or
body). The rotational movement is currently achieved with a simple
blue plastic key featuring a socket with two wrench surfaces, which
is available as an accessory under the designation GN 1151. Additional
drive types are currently under development.
The standard part GN 1150 is itself available in two versions: The
“front hygiene” version (FH) offers the HD standard on the actuation
side, while the inside satisfies the typical requirements. Applications
for this part include, for example, switch cabinets that must comply
with hygiene requirements only on the outside.
On the other hand, the “full hygiene” design (VH) features additional
seals for HD quality even on the latch arm side.
Both versions offer protection class IP 66 according to DIN EN
60529, meaning that they protect against the ingress of dust and
heavy streams of water from any angle.
The two standard parts are especially long-lasting thanks to a
carefully developed design. The seals are also available in other materials
upon request, allowing the parts to be adapted to customerspecific
media exposures.
Otto Ganter GmbH & Co. KG
Triberger Straße 3
D 78120 Furtwangen
Telefon: +49 7723 65070
Telefax: +49 7723 4659
eMail: info@ganternorm.com
Internet: http://www.ganternorm.com
www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 10-2023
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For applications with flow rates up to 2000 l/h – Product Line Expansion
Affordable Even at Higher Flow Rates:
New pump sizes of the ecosmart
diaphragm metering pump from
LEWA combine low purchase cost
with high performance
In many applications in the chemical industry, the food industry and
the oil and gas industry as well, pumps that work reliably and provide
high performance are needed. At the same time, they must have
convincingly low acquisition costs. With the ecosmart diaphragm
metering pump, LEWA GmbH from Germany has provided a good
value and safe model that can handle flow rates of up to 1000 l/h. For
use in applications with higher flow rates, the pump expert from Leonberg,
Germany, is now expanding its product range with the new,
powerful LCD variant. The model is designed for a flow rate of up to
2000 l/h. The maximum permissible operating pressure is 50 bar or
600 lbs. The stringent use of similar components within the ecosmart
range keeps production costs and therefore, the final price, low.
At the same time, a high level of safety can be guaranteed by focusing
on all essential design features such as the pressure relief valve
or the proven sandwich diaphragm with diaphragm monitoring. The
LCD variant will be available from September 2023.
For this model, too, LEWA engineers were able to successfully
implement the equal parts strategy they have often practiced. Pump
users also benefit from this intelligent modular principle, as many
wear parts can be used across pump types. This considerably simplifies
the spare parts inventory. At the same time, the modular principle
also allows individual adjustments to the respective application.
For example, stroke frequencies or plunger diameters can be selected
individually. The basis for this is the M900 pump head, which is
already used in the LCA and LCC variants, as well as in the ecoflow
program.
Good integrability for plant construction companies
The pump‘s flexibility also offers advantages for plant construction:
For example, the ecosmart pump can be aligned either vertically or
horizontally, making it easier to integrate the unit into systems with
a very small footprint. In addition, the pump head of the new LCD
variant is aligned at right angles to the plunger axis, resulting in a
particularly compact format. In many pumps, the pump head is on
the same axis as the plunger, which often results in bulky pump dimensions.
The 90° orientation of the new models avoids this. This
advantage is achieved by the extremely compact and completely redeveloped,
cost-effective diaphragm drive.
In order to ensure the long service life typical of LEWA pumps,
only high-quality, robust materials are used in the LCD version. As
with the other variants, the LCD complies with the U.S. metering
pump API industry standard 675, so it can be used for numerous
complex processes in a wide range of industries.
LEWA ecosmart LCD in horizontal design (Source: LEWA GmbH)
LEWA GmbH
D 71229 Leonberg
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
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