Newsletter_04-2024_EN

EN 04/24

Combining

stainless steel

and single-use

Success for a highly complex automation project

Combining stainless

steel and single-use

Whether it be stainless steel plant or single-use equipment, as a leading provider of customized automation solutions, ZETA

seamlessly integrates biopharmaceutical production systems into new or existing automation environments. A project with

a renowned life science company in Germany shows how customer-specific standards are implemented with intelligent

automation strategies. For the globally active pharmaceutical company, ZETA automated a stainless steel preparation plant

designed and manufactured in-house, as well as a filtration system from a single-use provider, integrating both systems into

the overarching process control system.

In the course of the large-scale expansion of an important pharmaceutical

production site in Germany – where drug solutions for injection

and infusion are manufactured – state-of-the-art technology

was applied to ensure the highest production standards. ZETA made

its contribution with a customized multipurpose plant consisting

of mobile preparation vessels and a cleaning station (CIP/DIP/SIP)

made of stainless steel. These were complemented by a filtration

system, developed by a single-use supplier, to minimize germ contamination

of the product.

The ZETA automation team faced various challenges, as the overall

responsibility for the automation of the two flexible systems –

stainless steel and singleuse – and their integration with the higherlevel

process control system lay in their hands.

Automation concept for a smooth process control

The ZETA experts installed the automation technology based on a

carefully developed automation concept. For this project, the Siemens

PCS7 process control system with SIMATIC Batch was used.

The application software designed for the plants was created using

the customer-specific programming guideline and the module library

specified b y t he c ustomer. D uring t he c onceptual planning

stages, special attention was paid to a high degree o f fl exibility o f t

he a utomated p rocesses. The finished software system was integrated

with the existing customer PCS7 server-client system.

Pharmaceutical production in accordance with GMP and GAMP5

Observing Good Manufacturing Practice (GMP) and complying with

standards and regulations is essential in pharmaceutical production.

Automation at ZETA follows the Good Automated Manufacturing

Practice guideline GAMP5. The creation of batch recipes and batch

records – in this project, the SIMATIC Batch software system was

used for this purpose – complies with the ISA-S88 standard for batch

control. All production plants are centrally monitored and controlled

by the process control system. The recipes are created according to

the requirements of the respective processes across all plants.

Maximum reliability in the production process

Cross-system automation architecture - stainless steel and

single-use systems running on the same controller.

As requested by the customer, automation was designed as a server-client

system with a central, redundant control system. The benefit

of redundancy lies in the fact that the “spare” system is ready

to take over operation in the event of malfunctioning, which means

that redundant systems can often prevent downtime. The automation

architecture of this extensive project has been designed in a

comprehensive way, with the stainless steel and single-use systems

programmed by ZETA running on the same controller.

In the completely virtualized process control system, both the

visualization and batch servers as well as the centralized programmable

logic controllers (PLCs) and the network infrastructure were

implemented redundantly. This ensures maximum reliability for the

production processes.

Targeted solutions for special automation challenges

Redundancy provides maximum safety during operation. However,

it was precisely this requirement for redundancy that called for special

automation know-how of the companies involved. Particular attention

had to be paid to the system redundancy S2. This specifies

the coupling of one or more devices to two redundant controllers

and must be guaranteed both physically and in the programming logic.

It is essential that the instruments and components that are to

be integrated into the bus system are also capable of S2 redundancy,

placing the highest demands on the suppliers of the components.

Additionally, during processing, different types of mobile containers

must be recognized by this redundant system and docked and

undocked from the single-use filtration unit. The undocking process

in particular presented a challenge for the ZETA automation t eam.

What’s more, the single-use filtration units are mobile, interchangeable

with each other and convertible in their mode of operation.

www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 04-2024

page 2/35

The ZETA engineers lived up to this challenge and successfully developed

a technical solution for this demanding piece of automation

architecture. Part of this is a special coding system in the connectors

that transmits power and signals. This way, the respective containers

can be identified by means of the digital inputs from the connectors.

The result: a user-friendly, safe automation solution for a highly flexible

production plant!

April 2024

Dear cleanroom professionals,

There are now only a few days left until

the Lounges 2024 will take place in Karlsruhe,

Germany, from 23-25 April. I am already looking

forward to the many discussions, handshakes

and personal contact. And, of course, we are very

keen to gather lots of information at the trade

fair and inform our readers about it afterwards.

Come to the trade fair and visit

us at our stand: 12.2

I look forward to talking to you in person.

A multi-project scheme managed by ZETA

ZETA acted as the overall supplier for the automation of the process.

The extensive project was also integrated into the higher-level,

highly complex automation architecture at the production site, with

the software designed to match. Within the vertical system integration,

the ZETA preparation and cleaning system and the single-use

filtration system fit seamlessly into the bigger picture, working together

with other important system components, such as the ultrapure

media supply or the filling system, at the user level.

In addition, t he ZETA automation experts built an interface for

the pharmaceutical manufacturer’s Manufacturing Execution System

(MES). Such interfaces are particularly important for intralogistics

and production control because key economic figures and production

data are linked at the MES and Manufacturing Operations

Management (MOM) level – the keyword being IT/OT convergence.

Accelerated time-to-market in biopharmaceutical automation

„Time-to-market“ is often the top priority in biopharma projects – as

a competent solution provider and central contact for automation,

ZETA masters this challenge by reducing interfaces, thus achieving

shortened project lead times.

A deep understanding of process know-how and the ability to

solve even the most complex challenges in automation make ZETA

a sought-after partner of the biopharmaceutical industry – this is

demonstrated not least by the success of this multi-project scheme

which was achieved together with the customer in Germany.

Before the fair is after the fair. And so this month

there are once again many interesting articles in

collected form:

> Combining stainless steel and single-use

> TekniPlex Healthcare to Expand Cleanroom

Film and Bag Production with New Multilayer

Blown Film Line

> Syntegon launches new SBM Essential Line

sterilizers: Standardization for shorter delivery

times

> The world’s fastest filling line for IDT Biologika

> Zero tolerance for medical devices

> From data glasses to robotic arms

– labs enter the digital age

> . . .

With kind regards

Reinhold Schuster

ZETA GmbH

A 8501 Lieboch/Graz


page 3/35

Space-saving stand-alone system for tests – even with small quantities

Production-related integrity:

Aseptic process diaphragm pump for field

trials on homogenization of demanding

emulsions with up to 150 l/h at 400 bar

Emulsions are finely dispersed mixtures of normally immiscible liquids. They end up on consumers‘ tables as homogenized

milk in the food sector, for example. They primarily consist of water, fat and protein. According to their nature, the fat droplets

contained in raw milk are not very homogeneous. For process engineering reasons, it is therefore important to reduce

their size in advance and achieve an even distribution. This is the only way that the end product can meet both the quality

requirements of the manufacturer and consumer expectations. However, as there are increasingly demanding emulsions

in other areas besides the familiar milk, such as baby food, pharmaceuticals, cosmetics or fine chemicals as end products

or even just intermediate products, which require the highest purity in particular, LEWA has developed the LEWA homogenizer

test system. The system can be used to test the aseptic functioning of a homogenizer based on a hygienic hermetic

process diaphragm pump. Thanks to a homogenizing valve that is also hygienic, it can be flexibly adjusted to the requirements

of different emulsions. The compact system can be integrated into both the circuit („stand-alone“) and the process

line, enabling it to be continuously operated aseptically. The fluid is supplied via an integrated heatable vessel or a separate

media connection. Visitors to Anuga FoodTec can see the compact, flexible pilot plant and its possible applications at booth

D085 in hall 4.1 and discuss potential customer benefits.

Not too creamy, not too runny: everyone knows how challenging

emulsions are: be it mixing a salad dressing or preparing a stable Béarnaise

sauce in your own kitchen. The requirements of industry go

far beyond those of kitchen preparation. „In addition to knowledge

of dispersion technology, there is an increasing focus on hygiene requirements

and uninterrupted robustness in industrial production.

And this is where the advantages of hermetic homogenization or

spray tower pumps come into play: for example, to maintain a stable

and pure product quality after heat treatment,“ said Dr.-Ing. Hans-

Joachim Johl, Lead Product Manager Life Sciences/Clean Processes

at LEWA GmbH. Put simply, the piston diaphragm pump is the

heart of the system for conveying fluids under high pressure through

a narrow opening. Due to the high shear and the resulting collision

of the droplets, they are crushed and evenly distributed. Alongside a

high-pressure pump used as a pressure generator, the systems used

in this field consist of a hydraulic consumer, which is called the „homogenization

valve.“ This often has a two-stage structure to counter

the re-agglomeration of fat droplets, for example.

The pump experts from Leonberg, Germany, have developed a

new rental and test system to meet the stringent requirements of an

efficient dispersion process from both the hygiene and process engineering

perspectives. It is based on proven triplex pump technology

and, thanks to its compact design and flexible control system,

can be easily integrated into pilot or even production environments.

With the LEWA homogenizer test system, the aseptic function of a homogenizer based on a hygienic

hermetic process diaphragm pump can be tested and flexibly adjusted to the requirements of

different emulsions thanks to an equally hygienic homogenization valve. (Source: LEWA)


page 4/35

In particular, products with unusual requirements such as fluids with

high undissolved abrasive components (e.g. calcium carbonate, tricalcium

phosphate) can be tested with the system from LEWA. Even

small quantities of expensive fluids can be tested in „stand-alone“

operation without any problem.

Optimal results from the interplay between pump and valve

The heart of the system is the proven LEWA triplex high-pressure

process diaphragm pump. It ensures that the process fluid flows

through the integrated two-stage homogenization valve at the required

flow rate and pressure. It is dynamically controlled and is de-

The flow rate and pressure required to homogenize the process fluid at

the two-stage, dynamically controllable homogenization valve are realized

by a LEWA triplex process diaphragm pump. (Source: LEWA)

signed for a maximum pressure of 400 bar and a flow rate of up to 150

l/h in the test system. The LEWA triplex piston diaphragm pump also

offers a decisive advantage for homogenization: Due to its design,

the diaphragm pump does not require dynamic sealing systems. The

PTFE sandwich diaphragm – additionally equipped with leakage detectors

– ensures a hermetically sealed working chamber, such that

no emission or leakage of substrate or cleaning media or contamination

of the fluid can occur. In addition to this function, which enables

aseptic process control, all media-relevant components are designed

in accordance with the applicable hygiene specifications, e.g.,

the „Hygienic design of pumps, homogenizers and steaming equipment“

EHEDG guidelines, and are easy to clean inline (CIP, SIP) –

but also easily accessible for inspection and maintenance purposes.

„The actual homogenization process benefits from the close

interplay between customer-specific conveyor units and system

components,“ explained Dr. Johl. First, a hygienic twin screw pump

generates a specified inlet or suction pressure on the suction side

of the high-pressure pump, which is particularly important for higher

viscosities. Next, the speed-controlled high-pressure diaphragm

pump conveys the fluid at the required flow rate to a preselected

pressure P2 in the second stage. The valve remains pneumatically

closed according to the selected pressure. As soon as the pressure

and pump capacity are reached, the homogenization valve of the

first stage closes to the extent that the specified value also applies

there. The valve of the second stage is now no longer controlled. „The

ratio between the pressures is usually P2 < 1/5 x P1, but it can also

be freely selected. The homogenization pressure of the first stage,

which is now leading, is maintained by pneumatic valve control of

the dispersion gap. In this way, the homogenization process remains

virtually free from pressure fluctuations. The choice of type and design

of the homogenization valves can be specified by the customer

for later scaling of production systems. Due to sufficiently selectable

pressure reserves, a later system can also directly supply a downstream

spray drying step, which further increases the efficiency and

flexibility of the process.

Compact design and flexible control for versatile use

All system components are selected according to hygiene requirements

and mounted on a common base frame, making the system particularly

suitable for pilot or small batch processes thanks to its compact and

space-saving design. (Source: LEWA)

The system can be operated both in a circuit and continuously in the

customer process. Fluid is supplied either via the heatable vessel or a

separate media connection. (Source: LEWA)

All components are designed for hygiene and are mounted on a

common base frame with a „wash-down housing“ for the pump drive.

This compact design enables the system to be installed such that

it saves space in the production environment. Depending on whether

it is operated in a circuit or continuously, the fluid is supplied via

either the integrated heatable double-walled tank with a capacity of

60 l or a separate media connection. In addition, the LEWA smart

control control system is integrated into a control cabinet mounted

on the metering frame: also in hygienic design. Various modes and

preconfigured operating sequences (cleaning, homogenizing, etc.)

are pre-installed for simple and flexible operation. „The safety of the

system is rounded off by various protective measures: a safety valve

that can be automatically vented for cleaning to protect the system

against overpressure on the low-pressure side, a pump-integrated

pressure relief valve on the high-pressure side and various pressure

and temperature transmitters for process monitoring, as well as visual

and acoustic warning elements,“ added Dr. Johl.

From March 19 - 22, 2024, visitors to Anuga FoodTec in Cologne

will have the opportunity to experience the LEWA homogenizer test

system in action. Dr. Hans-Joachim Johl and other LEWA experts

look forward to answering questions and having interesting discussions

at booth D085 in hall 4.1.

LEWA GmbH

D 71229 Leonberg


page 5/35

Bags Beyers Plastics

TekniPlex Healthcare to Expand

Cleanroom Film and Bag Production

with New Multilayer Blown Film Line

TekniPlex Healthcare, which utilizes advanced materials science expertise

to help deliver better patient outcomes, is expanding its capabilities

portfolio by commencing multilayer blown film manufacturing

in a cleanroom environment. Located at TekniPlex Healthcare’s

production facility in Puurs, Belgium, the new multilayer blown

film line exemplifies the company’s strategy to develop higher-order

barrier solutions per increased industry demand.

For TekniPlex Healthcare, the new multilayer line joins a number

of existing monolayer lines all inside ISO Class 7 cleanrooms at the

Puurs facility, for use in the production of cleanroom bags. The addition

comes as some healthcare market players are shifting from

food-grade resin-based bags to those comprised of pharma-grade

resins produced in GMP cleanroom conditions. In addition, Tekni-

Plex’ customers have expressed a need for higher barrier solutions

requiring multilayer film/bag capabilities.

Some segments of the pharmaceutical and medical device markets

demand high levels of cleanliness, either in their packaging or

processing, to produce or protect highly sensitive products. To meet

these needs, TekniPlex Healthcare has a longstanding history of

producing low-density polyethylene (LDPE) bags that meet strict

cleanliness requirements, with both film extrusion and bag sealing

conducted in cleanroom environments at the Puurs facility.

All TekniPlex Healthcare cleanroom-manufactured bags are

double or triple packed for use in customers’ cleanrooms, and can

be individually labeled for comprehensive supply chain traceability.

Custom resins or resin blends, including custom additives, are available,

as are certified sterilized products with Gamma irradiation.

The new cleanroom-housed blown film line is expected to begin

operation in Q2 of 2024, with full-scale commercial production following

shortly thereafter.

“There is a growing demand for films extruded and bags sealed

in cleanroom environments across various healthcare categories,”

said Bryan Wesselmann, VP of Sales and Marketing for TekniPlex

Healthcare. “The introduction of cleanroom production for multilayer

blown films and bags at our Puurs, Belgium facility demonstrates

our dedication to acquiring more extensive, market-responsive

capabilities. This expansion aligns with our goal of increasing capacities

and market share for our existing solutions portfolio.”

TekniPlex.

3000, Wayne, PA 19087

United States


page 6/35

Several thousand battery cells can be aged and analyzed simultaneously

in the laboratories.

Weiss Technik has supplied various

high-end test benches, climate chambers

and temperature test chamber

nisms of battery cells and systems as well as

power electronic components and systems.

An investment of over 100 million euros has

created a unique, interdisciplinary research

center that can model, measure and optimize

the service life and reliability of batteries,

The CARL: Center for Ageing, Reliability

and Lifetime Prediction of Electrochemical

and Power Electronic Systems was opened

at the ISEA Institute at RWTH Aachen University

in 2023. More than 120 researchers

are analyzing the aging and failure mechafrom

the molecular level of a battery to the

chemical processes involved in charging and

discharging under various influencing factors

to the behaviour in coupled systems. Several

thousand battery cells can be aged and

analyzed simultaneously in the laboratories.

Weiss Technik has supplied various

high-end test benches, climate chambers

and temperature test chambers for environmental

tests and continuous cycling for

CARL. They are used in 40 containerized

test cells and other laboratories, primarily

for checking model assumptions and verifying

measurement results.

Stephan Bihn heads the Battery System

Technology and Vehicle Integration department

at the Chair of Electrochemical Energy

Conversion and Storage Systems Technology.

He describes how the collaboration between

materials scientists, chemists, physicists,

mathematicians and electrical and

mechanical engineers is rapidly increasing

our understanding of the system. Whether

Prof. Figgemeier‘s group is analyzing interface

effects at the material level, Prof. Sauer‘s

department is modeling the behavior

of the battery cell or Prof. de Doncker is developing

a new charger or a new drive - the

knowledge is in-house. The connection to

Münster University, the Helmholtz Institute

and the Fraunhofer FFB is particularly close.

Weiss Technik recently supplied a drying

room for the FFB in Münster and is currently

building a second one.

At CARL, weisstechnik‘s devices are

used in a variety of ways to achieve the goals

set: optimal battery systems for stationary

and mobile applications - from the initial

design, selection of the most suitable battery

cells and electrical dimensioning, the

battery management system, thermal management,

detailed CAD designs through to

physical and functional integration into the

application and suitable tests.

Weiss Klimatechnik GmbH

D 35447 Reiskirchen


page 7/35

Syntegon launches new SBM

Essential Line sterilizers:

Standardization for shorter delivery times

– Vacuum-steam, steam-air mixture, or combined sterilization process for a wide range of applications

– Annex 1-compliant thanks to automated air detector module

– Large selection of sizes and options ensure maximum flexibility

ber and documents the measured values

so that pharmaceutical manufacturers can

comply with the requirements of the new

Annex 1 both effortlessly and effectively.

Further options such as automatic inline

filter sterilization also help ensure an

increased level of product safety. The optional

high-pathogen program of the SBM Essential

Line is suitable for use in laboratories

that work with highly potent substances or

for the production of BSL (bio safety level)

preparations. “For example, pharmaceutical

containers that have come into contact with

infectious biological substances can be sterilized

safely, protecting both operators and

the environment,” Dallner explains.

Modular and demand-oriented

With the SBM Essential Line, the Syntegon

subsidiary Schoeller-Bleckmann Medizintechnik

(SBM) launches a new series of its

sterilizers, which are based on 50 years of

experience. “Thanks to the standardized basis

of the SBM Essential Line, pharmaceutical

manufacturers benefit from significantly

shorter delivery times and attractive prices,”

explains Christian Dallner, product manager

at SBM. “At the same time, the large selection

of sizes and options ensures that every

manufacturer finds the right solution for

their sterilization loads and applications.”

Two processes in twelve sizes

The sterilizers of the SBM Essential Line

use either a vacuum-steam (ADV), steamair

mixture (SDR) or a combined (SDT) process

to sterilize porous and solid equipment

as well as liquids in containers such as vials,

The new SBM Essential Line sterilizers with vacuum-steam, steam-air

mixture, or a combined sterilization process are suitable for a wide range

of applications thanks to their modular design.

cartridges, or pens. Fans, jacket cooling, and

internal heat exchangers are available for

rapid cooling after the sterilization process.

SBM offers the basic pressure vessel of the

SBM Essential Line in twelve different sizes,

covering chamber volumes from around 200

to 3,500 liters.

Maximum safety for demanding applications

The optional air detector module for the

ADV and SDT sterilizers is particularly relevant

in view of Annex 1, which took effect

in August 2023. Chapter 8.61 requires daily

air removal tests or the use of an air detector

system to prove the complete purging of air

from the sterilization chamber and the load

to be sterilized. The air detector module of

the SBM Essential Line automatically detects

non-condensable gases in the cham-

The software components of the SBM Essential

Line are just as customizable as the

rest of the equipment. The new, more powerful

high-performance control system

with Win CC visualization is, however, installed

by default in all sterilizers of the series.

Apart from a more comprehensive display,

it also offers more detailed protocols.

The user-friendly features, great flexibility,

and cost-effectiveness of the SBM

Essential Line sterilizers prove convincing:

“We are already speaking with the first customers.

Their feedback confirms that our

new, modular approach will meet additional

needs from the industry and our customers,”

Dallner concludes.

Syntegon Technology GmbH

Blaufelder Straße 45

D 74654 Crailsheim

Telefon: +49 7951 4020

eMail: packaging-ph@syntegon.com

Internet: http://www.syntegon.com


page 8/35

Advancements in laser technology are accelerating progress in 3D bioprinting

of organs, a process that has the potential to help meet a growing worldwide demand

for organ transplants.

Transition to Laser-Based 3D Bioprinting:

Stride Towards Addressing Organ Shortage

Recent advancements in laser technology are leading to groundbreaking

developments in the medical field, from improved treatment

of cardiovascular diseases to higher-precision manufacturing

of medical devices.

Improvements in the speed and accuracy of laser technology are

also at the root of the latest advancements in 3D bioprinting, setting

the stage for rapid progress toward the creation of 3D-printed organs

for transplantation. In the face of a growing organ donor shortage,

laser-based bioprinting has the potential to help medical researchers

meet the increasing worldwide demand for organ transplants.

The role of lasers in 3D-printing organs

Bioprinting is the process of precisely layering biomaterials, also

known as bioinks, to form three-dimensional structures, from biological

tissues to larger-scale organs. While bio-printed tissues are

currently being used for medical research like drug testing, biotech

firms are pushing the technology further, toward the development of

full-sized 3D-printed organs for transplant.

Laser-based bioprinting is a cutting-edge technology that is helping

to speed up this pursuit. According to Vidmantas Šakalys, CEO

of Vital3D Technologies, a biotech company that specializes in 3D

bioprinting solutions, the primary benefit of using lasers in bioprinting

is their ability to enhance the speed and precision of the process.

“Using lasers in the bioprinting process allows for more precise

control over the placement of cells and biomaterials, at the microscale

level,” Šakalys says. “Laser-based methods can be made to be

relatively fast and precise, compared to other bioprinting techniques.

This is important for large-scale tissue fabrication, where speed is

a key factor. Overall, lasers allow for a more nuanced manipulation

of bio-inks, which is indispensable when replicating sophisticated

organ structures.“

From speed and precision to improved patient safety

Successful bioprinting is about more than just speed and precision,

Šakalys says. “Laser-based bioprinting is relatively gentle compared

to other techniques. This helps to minimize damage to cells during

the printing process and improve the overall viability and functionality

of printed bio-structures.”

Lasers also help ensure that printed tissues have the appropriate

structural characteristics, such as correct density, elasticity, and

permeability, which are vital for their successful integration into the

host body. By using this method, bio-printed tissues are treated as an

extension of the body rather than a foreign object. This significantly

reduces the risk of tissue rejection and limits the need for immunosuppressant

drugs, which patients who receive transplants are often

required to take.

Advanced laser technology helps ensure a higher degree of accuracy

than traditional techniques, which contributes to increased

patient safety and better medical outcomes,” says Šakalys. “Laserbased

bioprinting is not just about creating structures, it‘s also about

creating safe, viable, and compatible living tissues for medical

applications.”

Some challenges remain

Despite its advantages, laser-based bioprinting still faces some challenges

that need to be overcome to capitalize on its potential fully.

One significant challenge is the high cost and complexity of laser

equipment, which may limit its widespread usage in the medical

field. Laser bioprinting is a time-consuming process, and is currently

capable of producing only small structures. As such, clinical applications

at present are somewhat limited.

Nevertheless, ongoing research and technological developments

point to the possibility of tackling these issues, pushing laser-based

bioprinting to new frontiers of biomedical science.

(Photo credit: Vital 3D )

Vital3D

10224 Vilnius

Litauen


page 9/35

Novel development for pH measurement at Fraunhofer IPMS

Innovation in sensor technology:

Development of a new pH sensing layer

successfully integrated into an ISFET

Fraunhofer Institute for Photonic Microsystems IPMS announces a significant advance in chemical and biochemical

analysis. The team led by Dr. Olaf R. Hild, Head of the Chemical Sensor Technology Business Unit, has successfully developed

a pioneering sensing layer for chip-based pH measurement has and successfully integrated it into an ion-sensitive

field-effect transistor (ISFET).

The pH of a solution is the most important parameter in chemical

and biochemical analysis. An ISFET with a novel sensor layer developed

by Fraunhofer IPMS, in combination with a conventional

reference electrode, enables highly precise pH measurement in the

range from pH 1 to pH 13. The compact, unbreakable sensor chip

with dimensions of 5 x 5 mm² is characterized by a minimal drift of

< 20 µV/h as well as low hysteresis while being easy to integrate. A

significant improvement has also been achieved in the reduction of

light sensitivity.

The dry storage capability of the sensor is one of its primary advantages.

Moreover, the electrical operating point of the sensor can

be flexibly adjusted via the design and the operating parameters,

whereby an operating voltage (VDS) of below 1V is possible.

Dr. Hild, head of the research team, expressed his enthusiasm for

the measurement data achieved by the mechanically robust sensor:

„With these properties, the new ISFET is particularly suitable for onsite

environmental analysis.“ Dr. Hild went on to emphasize that the

next important research goal is to develop a sensor layer that enables

a purely chip-based pH measurement that eliminates the need for

conventional reference electrodes. This breakthrough technology

would then have the potential to continuously collect environmental

data over long time periods without the need for intervention by

operating personnel.

Physical principles of the ISFET from Fraunhofer IPMS

The novel ISFET from Fraunhofer IPMS is based on metal-oxide-semiconductor

(MOS) field-effect transistor technology, whereby the

sensor area in contact with the medium consists of an amphoteric

metal oxide layer. Hydronium or hydroxide ions from the medium

are reversibly adsorbed on this sensing layer, allowing for the pH of

the medium to be measured. The gate-to-source voltage (VGS) response

versus a reference electrode (Ag/AgCl in 3 M KCl) is then used

as the measurement signal.

Some of the research results were achieved in the „REISen“ project,

a project from the Department of Materials Science, which was cofinanced

from tax funds on the basis of the budget approved by the

Saxon state parliament.

The developments of Fraunhofer IPMS contribute significantly

to the further development of environmental analysis and open up

new possibilities for more precise and more efficient data acquisition

in the field of chemical analysis.

Fraunhofer-Institut für Photonische Mikrosysteme IPMS

D 01109 Dresden

ISFET sensor chip from Fraunhofer IPMS.

© Fraunhofer IPMS Simplified illustration of an ISFET with an Ag / AgCl reference electrode. © Fraunhofer IPMS


page 10/35

EU-funded JOIN4ATMP project aims

to overcome regulatory obstacles

They offer hope for people who do not respond to conventional treatments or

for whom there is no effective therapy yet available: advanced therapy medicinal

products (ATMPs). The first of these novel medications, developed using genetic

and cell technologies, were officially approved just five years ago. Some of them

have been great successes, while others have made a mere blip on the market.

JOIN4ATMP, a Europe-wide project, is now being launched under the coordination

of Charité – Universitätsmedizin Berlin, with support from the Berlin Institute

of Health at Charité (BIH). The project aims to identify the obstacles standing

in the way of these new treatments and determine what is needed to ensure

that people in Europe can have fast, safe, and equitable access to them.

netically modify them in a lab so that, once

reintroduced into the body, they can detect

and destroy cancer cells. ATMPs can be tailored

to individual patients more effectively

than traditional medications, which makes

them especially suitable for treating rare diseases

and cancers that currently have no or

inadequate treatment options.

Although there are many ATMPs currently

in development, very few have been

approved for the European market to date.

The problem is that the regulatory rules for

approval of conventional medicinal products

– which require clinical trials involving

large numbers of patients, for example

– do not translate to these complex gene and

cell therapies.

Reshaping the landscape

GMP-compliant manufacturing of gene and cell therapies in a special lab at Charité

© Charité | Arne Sattler

Gene and cell therapies are among the most

important innovations in the healthcare

sector. And they reflect advances in science

and technology. They have the potential to

radically reshape the treatment of cancer,

autoimmune diseases, neurodegenerative

disorders, and many rare genetic conditions.

But the path to approval and clinical use

of these products is long and often fraught

with difficulty.

That was the reason the European University

Hospital Alliance (EUHA) founded

the European Center for Cell and Gene

Cancer Therapies (EUCCAT) four years ago.

The center’s aim is to facilitate the clinical

use of ATMPs developed at higher education

institutions and further consolidate the

basic research conducted in Europe. The

newly launched JOIN4ATMP project originated

with the virtual institute. All members

of the EUHA, together with the existing

EU-funded RESTORE and T2EVOLVE

networks, biotech companies, and patient

advocacy organization EURORDIS – Rare

Diseases Europe, will work together to identify

obstacles and propose solutions geared

toward real-world practice – so that these

innovative treatments are made affordable

and accessible to all patients.

“Living” medications

ATMPs are based on genes, tissue, or cells,

so they often contain living components. For

example, it is possible to take white blood

cells from a patient with leukemia and ge-

This is where JOIN4ATMP, which is slated

to receive about three million euros in funding

from the European Commission over

a three-year period, comes in. “Our goal is

to devise concrete recommendations for

how patients in Europe can gain access to

innovative gene and cell therapies faster,”

says Prof. Annette Künkele-Langer of the

Department of Pediatric Oncology and Hematology

at Charité, which is leading the

consortium. “To that end, we are bringing

knowledge and experience in preclinical

development, production, clinical testing,

market approval, and reimbursement of

ATMPs together Europe-wide and analyzing

the obstacles and how they can be

overcome at the medical, regulatory, and

economic levels.” The experts will present

their conclusions in the form of guidelines,

recommendations, and white papers, thereby

advancing the European strategy for

novel therapies. They will form the basis for

new approval processes tailored to ATMPs

and create the overall conditions needed

for standardized, decentralized manufacturing

of gene and cell therapies even as the

application of rigorous good manufacturing

practices (GMPs) is expanded at the European

level.

Charité – Universitätsmedizin Berlin

D 10117 Berlin


page 11/35

The world’s fastest filling line

for IDT Biologika

To have additional filling capacity available quickly, contract

manufacturers such as IDT Biologika need lines that

are ready to produce large batches in the shortest possible

time. IDT‘s latest investment shows how this is done: together

with Syntegon, the company installed one of the fastest

state-of-the-art filling lines in the world. It achieves a capacity

of 80 to 100 million 2R vials per year and batch sizes of

up to 500,000 containers – including 100 percent in-process

control.

The demand for vaccines, viral vectors, and other biologics is rising

continuously. Contract Development and Manufacturing Organizations

(CDMOs) that have the necessary infrastructure for all relevant

biosafety levels and are proficient in handling live viruses are in high

demand. This also applies to IDT Biologika: The vaccines that the

company has developed in collaboration with pharmaceutical companies

over the past decades protect people against infectious diseases

such as tuberculosis, AIDS, malaria, dengue fever, and Ebola.

IDT also took on an important role during the Covid-19 pandemic

by producing vaccines for AstraZeneca and Janssen on short notice.

The company had, however, recognized the growing capacity need

much earlier. Even before the pandemic, the contract manufacturer

was planning extensive investments to expand production at its

headquarters in Dessau-Roßlau, Germany. When IDT Biologika was

looking for a new, state-of-the-art line for the aseptic filling of commercial

products, the company made speed the top priority. In addition,

the fill-finish line needed to process large volumes and offer

maximum flexibility with various filling systems.

SAT three weeks ahead of schedule

In June 2020, IDT awarded the contract to Syntegon. ”We received

an ideal design concept for a complete line from a single source, including

an isolator within our desired time frame,“ says Axel Goertler,

head of strategic engineering and process design at IDT Biologika.

”With the new line, we wanted to fill our customers’ products

even more flexibly, faster and to an even higher quality standard.” To

master this complex task, a core team of five interdisciplinary experts

from Syntegon laid the foundation for the successful construction of

the filling line.

The SAT was successfully completed in less than 18 months –

three weeks ahead of schedule. ”In times of Covid-19 and supply

bottlenecks, professional project management was more

crucial than ever. The key to success was direct and transparent

communication,” says Steffen Grune, senior engineer at IDT

Biologika.


page 12/35

Fast, flexible, and safe

The filling line itself matches the speed that both project partners

initially envisioned. With a filling capacity of 80 to 100 million 2R

vials per year and batch sizes of up to 500,000 containers, it is one of

the fastest filling lines in the world, amongst other things thanks to

its double magazine with precise piece count. The line also delivers

in terms of flexibility. Thanks to several filling systems and format

sizes from two to ten milliliters, it can process a wide variety of products.

Syntegon’s proven isolator technology provides the best possible separation

of the operating and process areas. “We decided to run an

H2O2 cycle not only before but also after filling,“ says Goertler. In addition,

the previously cleaned vials are sterilized and depyrogenated

using dry heat.

The highest quality through inline inspection

IDT even goes beyond the prescribed minimum standards for quality

assurance. The optional empty vial inspection takes place right

at the beginning of the process. Cameras check the integrity of the

containers before filling and examine the vials for contamination

through foreign bodies. Defective vials are automatically ejected by

the system. ”With our very high processing speed of up to 600 vials

per minute, we need this additional inspection process to avoid losing

expensive active ingredient,” Goertler adds.

A 100 percent in-process control (IPC) makes sure that each of the

previously approved vials contains the exact amount of active ingredient

by weighing each vial before and after filling. An additional

print is applied with UV ink and verified by means of a camera during

crimping. A special containment system ensures maximum operator

protection during printing and print counterchecking. In addition,

integrated cameras and sensors monitor and document every step of

the process; network cameras provide the necessary documentation

if required.

An investment with foresight

IDT Biologika sees itself in an excellent position for the future. ”Our

new high-speed line enables us to respond quickly to demands and

expand our manufacturing capabilities,” says Grune. The option of

retrofitting the line with two freeze dryers is also a far-sighted investment.

IDT has already installed the appropriate pure media systems.

The vial cleaning machine is supplied with WFI and pure steam via

a pure media system from the Syntegon subsidiary Pharmatec. The

WFI loop, which is already connected to the cleaning machine, can

also supply the two potential freeze dryers. ”Studies show that lyophilizates

will play an increasingly important role in the future. Freeze-dried

pharmaceuticals offer advantages in storage and shelf life

and are used exactly when they are needed. This can be a decisive

advantage, especially for vaccines needed at short notice,” Grune

concludes.

Syntegon Technology GmbH

Blaufelder Straße 45

D 74654 Crailsheim

Telefon: +49 7951 4020

eMail: packaging-ph@syntegon.com

Internet: http://www.syntegon.com


page 13/35

Healthcare: innovative testing system for auto-injectors

Zero tolerance for medical devices

Not every injection has to be given in a doctor‘s practice. There are a number of medications that patients can administer

themselves via auto-injectors and the demand for them is increasing worldwide, partly because lifestyle diseases such as

diabetes are still on the rise. Understandably, these medical products are subject to particularly high safety and functional

requirements. This is why a renowned customer from the pharmaceutical industry relies on a fully automated testing system

from PIA Automation for the quality control of their injectors.

Ramona Neulinger, Project Manager at PIA.

(Source: PIA Automation)

The use of auto-injectors, which are filled

with medication for the treatment of conditions

like diabetes or rheumatism, is very

simple for patients: the cap is removed, the

plastic cylinder is pressed against the skin

and, when a defined pressure is applied, a

fine needle emerges from the tip and injects

the medication under the skin.

Test criteria are: faultless function and

absolute safety

The PIA customer produces large quantities

of these medicine containers every day.

Employees take random samples by hand,

manually checking for various safety and

function-relevant parameters, which the

PIA system checks fully automatically. The

employees place the auto-injectors horizontally

in trays. A fully loaded tray trolley

contains eleven trays with up to 400 injec-

tors. The fully automated testing process begins

when the first of the trays is moved into

the system. A handling gripper then removes

an injector and takes it to an axis system

with a gripper. This rotates the injector by 90

degrees into a vertical position and inserts

it into the first station, where the protective

cap is removed. The gripper picks up the ready-to-use

injector again and transfers it to a

handling system, which then inserts it into

the test station. There, a servo press triggers

the injection mechanism.

The test station measures the force required

for triggering, the distance the pen is

compressed until activation, the time from

the start to the end of the injection as well

as the amount of active ingredient dispensed,

which the auto-injector deposits into

a measuring cup. The station also monitors

whether the needle is intact. A visual indicator

signals that the auto-injector has been

An auto-injector is removed from a tray –

shown here using a sample component.


During the function test, the autoinjector

releases the active substance into a

measuring container to measure the quantity.


At the first station, the cap of

the autoinjector is removed.



page 14/35

The customer required a compact automated testing system. (Source: PIA Automation)

used and emptied. This mechanism is also

monitored.

To prevent users from injuring themselves

on the extended needle in real-life use,

the injectors extend a needle protector after

dispensing the medication. The system also

checks the blocking force of this protective

mechanism and tests whether the needle

protector holds securely under high pressure.

Among other things, the system checks

the amount of active ingredient dispensed.


Maximum precision

for minimum tolerances

“The system‘s measurements are very extensive

and have to be extremely precise.

Medical products only allow minimal tolerances

and require absolutely reliable processes,”

says Ramona Neulinger, Project

Manager at PIA. The values for release force,

path, and pressure on the needle protector

are measured by a servo press. The optical

control of the needle, drop formation and

spent indicator is carried out by two camera

systems that record 500 images per test procedure.

The precision scale for measuring

the amount of active ingredient dispensed

has a resolution in the milligram range The

scales are structurally decoupled from the

rest of the system in order to rule out measurement

errors caused, for example, by vibrations.

After the inspection, the handling gripper

places the injectors back in the tray. If a

random sample shows any abnormalities, it

is sorted out and kept in a special holder ready

for a follow-up inspection by the company‘s

employees. Because every auto-injector

produced has an individual data matrix

code, the path of a defective device can be

clearly traced back through production.

Configurable for different auto-injectors

A particularly innovative feature of the new

system is the capability to configure it for

more than one type of auto-injector, so the

customer is initially planning to test two

types of auto-injectors in the system. The

scope of delivery also includes the calibration

equipment, which is used to test the system

and the function of the test processes

at specified intervals. Among other things,

the equipment includes various weights to

calibrate the precision scales exactly.

The new system will go into operation

at the customer‘s premises in the coming

months. With it, PIA is continuing a very

good collaboration that began back in 2010

and, since then, PIA Automation has also

developed and installed several assembly

and automated testing systems for this

customer. “The joint development of the

system once again demonstrates the excellent

cooperation with the customer and

a functioning simultaneous engineering

process,” says Ramona Neulinger, summing

up the status quo of the current project.

One of the customer‘s requirements

was to develop the system for the laboratory

using as little space as possible and to

implement all testing processes in a very

confined space. “We were able to meet all

the requirements. We constantly monitored

progress in weekly meetings and continuously

developed the system design

based on the results already achieved,”

says Ramona Neulinger.

PIA Automation Holding GmbH

D 97616 Bad Neustadt a. d. Saale


page 15/35

Thomas Maischberger (left) new Corporate Head

of Research and Development at ZETA.

Together with a major customer, ZETA developed a reusable, environmentally

friendly and stable connectivity solution for the transfer of

liquids in the aseptic processing of biopharmaceuticals and foodstuffs.

The road to market readiness:

How Zeta drives innovation

ZETA’s declared mission „Accelerating the process of bringing

drugs to market in order to save lives“ already calls for

innovative approaches. In fact, innovation is deeply rooted

in the core of ZETA’s corporate culture. Driven by curiosity,

enthusiasm, and a spirit of innovation, ZETA experts develop

new products, solutions, and technologies for the pharmaceutical

and biotech industries. A working environment

where all employees have the opportunity to contribute

their expertise is crucial.

equipment components such as reusable sterile connectors for liquid

transfer are also constantly being developed. ZETA is driving

digitalization forward: Smart Engineering Services represent a software

platform based on an integrated engineering toolchain. Integrated

engineering combined with end-to-end digitalization of data

results in the digital twin of the production system, enabling valuable

smart tools, such as the Smart Maintenance Navigator app and paperless

qualification as part of Integrated Digital Testing.

Best Practice Beispiele aus ZETA R&D

Starting from the tangible benefit for the customer

Whether researching new technologies or developing innovative

products, ZETA’s customer-centric approach is always about creating

a specific benefit or added value for the customer. “We work in

an applicationoriented way and usually start with very specific problems,”

explains Thomas Maischberger, who was recently appointed

Corporate Head of Research and Development. “We strive to push

the boundaries of what biotechnological systems can achieve. Our

aim is to translate the promise of new drugs into actual production

facilities or systems, so that these therapeutics can reach the market

and patients as early as possible.”

A key feature of ZETA is its integrated research approach, in

which research and engineering go hand in hand within interdisciplinary

teams. This involves working very closely with customers and

regularly with universities and other research institutions.

Current highlights and research focus areas

ZETA’s innovation map ranges from data science, integrated engineering

approaches and production simulation to issues relating

to the sustainability of production sites. The list of innovative solutions

and products is correspondingly long. An important focus

of research is the characterization and optimization of bioreactors.

Another major topic is magnetic agitator technology, which thanks

to ZETA has made enormous progress in recent years. Innovative

Product development: multi-use sterile connectors

True to the motto “Developing better solutions for the f uture t ogether”,

Z ETA a nd a m ajor c ustomer based in Vienna succeeded

in developing a reusable, environmentally friendly, stable connection

solution for the transfer of liquids during aseptic processing of

biopharmaceuticals and foodstuffs. Simple, quick, and safe to use,

ZETA sterile connectors are particularly suitable for mobile containers.

The connection process can be carried out in the general

production area and does not require any additional technology to

ensure the sterile integrity of the system, for example laminar flow.

Stainless steel connectors and clamps are used to create a dry connection

between two separate fluid pathways.

The system is suitable for all standard pipe and hose dimensions

and has numerous advantages: The mechanical stability, pressure

load tolerance and temperature resistance are high. The components

can be cleaned and autoclaved and their reusability makes

them particularly environmentally friendly. High process reliability is

guaranteed for aseptic applications in all areas – from upstream and

downstream to fill-and-finish.

A hands-on service: ZETA’s research bioreactor

In collaboration with the Styrian biotechnology company Bisy, ZETA

operates a 50L bioreactor equipped with all relevant functions that is

used for internal research and for the implementation of innovations


page 16/35

ZETAs Innovation Labs

The further development and optimisation of magnetic agitator

technology is being driven forward at the TechCenter ZETA.

on a process, simulation, automation and sensor level. The “ZETA

Bire System” is ideal for collaboration projects with universities and

industrial partners, as well as for external contract projects.

As an absolute all-rounder, the system can map a complete

upstream process with living organisms. Bisy uses also for training

purposes. The current focus is on the development of a new control

algorithm for dissolved oxygen, which individually adjusts the oxygen

saturation in the medium to the living culture via the optimum

combination of agitator and gassing performance. Another area of

focus is the implementation of the MTP concept on the Siemens SI-

MATIC PCS neo platform.

Forward-looking process automation: the MTP concept

Versatile, modular systems are the process industry‘s answer to

constantly changing market requirements. Flexible technical solutions

for the automation of modular plants are particularly high in

demand – only with these can modular plant construction be implemented

consistently.

The „Module Type Package“ (MTP) concept gives the individual

modules a digital description and enables them to be flexibly connected

and orchestrated, in the sense of a plug & produce system.

Production capacity can be increased by adding MTPready modules,

and flexible reconfiguration allows for the production of different

products. Standardization and modularization, both being driven

forward by numerous companies and organizations, are already well

advanced and the corresponding tools are available. The automation

experts at ZETA are now working on a seamless integration of modules

with process automation.

Process intensification: inline conditioning

Buffer solutions are essential media in the production of therapeutic

proteins and other biomolecules. Increasing production titers,

shorter batch times, capacity expansion of existing facilities and

the intensification of bioprocesses have increased the volumetric

demand for buffers and have led to operational bottlenecks. While

many production facilities have improved their capacities through

inline dilution of concentrates, the demand for buffers continues to

rise. As a result, the supply with buffer solutions remains labor intensive

and logistically challenging.

Proper planning and implementation of inline conditioning systems

will alleviate production bottlenecks. Inline conditioning enables

just-in-time preparation of buffers by mixing stock solutions.

The advantages: the need for production space is minimized and

flexibility in the use of buffer solutions is maximized.

The TechCenter ZETA in Lebring provides an important research

environment with space and infrastructure for various experiments

and test series. However, it is by no means the only location where

innovative concepts are developed. The topics of digitalization and

data science are concentrated at the ZETA headquarters in Lieboch.

In the field of automation, the Innovation Hubs conduct research at

the ZETA site in Hallbergmoos and at SIGMA in Goldbach, Germany.

ZETA in Vienna has a strong focus on process innovation, and

the experts at Biotree in Bangalore are responsible for operator training.

ZETA Innovation Labs sees itself as a hub for talents, bringing

together entrepreneurs, researchers, investors, and experts.

There are currently 1400 employees working at 28 ZETA locations –

an enormous potential of knowhow and creative ideas just waiting

to be explored. In a research environment where all employees can

contribute their respective expertise, the spirit of innovation is put

into practice.

“In terms of R&D, we are currently working on adapting our

structural organization, which will enable us to work together even

more efficiently”, explains Thomas Maischberger, Corporate Head

of Research and Development. “There will be a rather small permanent

R&D team, which will be flexibly supplemented by experts

from the various departments depending on research field, project,

or questions to be explored. A suitable team will be put together for

each research topic.”

The structure of the R&D department is intended to support ZETA‘s

global approach to innovation, which aims to break new ground with

foresight, and exchange t he k nowledge o f e mployees i n a m eaningful

way.

A glimpse into the future

There are some industry trends that clearly indicate which topics will

be in focus in the coming years. Thomas Maischberger and the ZETA

team are working on products and services related to plant modularization,

process intensification, integrated engineering, and the

simulation of production processes.

In the long run, Maischberger expects that topics such as AI,

digitalization, and platform-based process modeling will be the

essential technologies that will step up productivity. Overarching

questions related to climate change, resource scarcity, and incurable

diseases will also be at the forefront of discussion. Looking to the future,

the ZETA expert explains: “As an interdisciplinary team, we will

be more challenged than ever to address complex issues as quickly

as possible.”

No progress without innovation

Change and innovation are essential elements of ZETA’s corporate

strategy. Managing Director Andreas Marchcler is convinced that

“without continuous development, there is a risk of stagnation”. “Innovations

are the key to success and tomorrow‘s earnings. At ZETA,

we see innovation as a fundamental corporate value. We create

spaces for inspiration, the generation of ideas, and the targeted implementation

of innovations to ultimately create added value for our

customers with our solutions. The ongoing inclusion of our industry

partners ensures customer benefit and, therefore, success.”

ZETA GmbH

A 8501 Lieboch/Graz


page 17/35

Advances in processes, masks and metrology will enable to fully benefit

from the resolution gain offered by the first ASML 0.55NA EUV scanner

Imec demonstrates readiness of the

High-NA EUV patterning ecosystem

Field stitching is a key enabler in High-NA: field stitching is needed

because of the anamorphic lens (i.e., a lens with different de-magnification

in the x and y directions), resulting in field sizes of half of the

conventional scanner field size. Imec will share the latest insights

that enable at-resolution stitching based on work done with ASML

and our mask shop partners on imec’s NXE:3400C scanner. At-resolution

stitching will reduce the need for design changes to cope

with the field size reduction.

Assembly of a High NA EUV tool in joint imec-ASML High-NA lab at

ASML’s headquarters in Veldhoven, the Netherlands. (Credit: ASML)

This week, at the 2024 Advanced Lithography + Patterning Conference,

imec, a world-leading research and innovation hub in nanoelectronics

and digital technologies, will present the progress made in

EUV processes, masks, and metrology prepared for enabling highnumerical

aperture (High-NA) extreme ultraviolet (EUV) lithography.

Key achievements are reported on resist and underlayer development,

mask enhancement, optical proximity correction (OPC)

development, at-resolution field stitching, reduction of stochastic

failures, and improved metrology and inspection. With these results,

imec demonstrates readiness for transferring the EUV processes

into the joint imec-ASML High-NA EUV Lab, built around the first

prototype High-NA EUV scanner.

Steven Scheer, senior vice president of Advanced Patterning, Process

and Materials at imec: “The first High-NA EUV scanner (TWIN-

SCAN EXE:5000) has been assembled by ASML and the first wafers

will be exposed soon. In the next few months, the joint imec-ASML

High-NA EUV Lab will be operational, and access will be provided

to the High-NA customers. The High-NA EUV lab, with the installed

equipment and processes, enables an early start of High-NA EUV

learning for the customers before tools are operational in their fabs.

It has been imec’s role, in tight collaboration with ASML and our extended

supplier network, to ensure timely availability of advanced

resist materials, photomasks, metrology techniques, (anamorphic)

imaging strategies, and patterning techniques. Readiness of these

processes for High-NA enablement is shown in more than 25 papers

presented at the 2024 SPIE Adv Litho & Patt Conference.”

On the material and process side, it is clear that metal-oxide resists

(MORs) are still in the lead for metal line/space patterns. Imec will

present the advancements of MOR in terms of EUV dose-to-yield

reduction. The selection of the specific underlayer, optimization of

the development process, choice of mask absorber, mask bias and

mask tonality were leading to a more than 20% dose reduction for

lines and spaces, without increased roughness or stochastic failures.

Also, tip-to-tip dimensions were not negatively impacted by these

dose reduction activities. The dose reduction work continues and

is highly appreciated by our chip makers, since it leads to EUV cost

reduction due to the higher scanner throughput.

An unexpected result was obtained by using MOR resists with a

binary bright field mask for contact hole patterning. A 6% dose reduction

with a 30% local CD uniformity (LCDU) improvement was

achieved after pattern transfer when comparing to a positive tone

chemically amplified resist (CAR) and a binary dark field mask transferred

in the same stack. A remaining concern of bright field masks

for contact holes is the mask quality and defectivity. This will need

careful investigation to make MOR an option for contact holes. Until

then, positive tone CAR resists with dark field masks will be the

leading candidates for contact and via patterning in High-NA EUV.

High-NA also requires improvements in metrology and inspection,

giving the higher resolution (by the high NA) and thinner films

(by the reduced depth of focus (DOF)). Imec will present new results

on e-beam and deep-UV (DUV) inspection, showing that new

best-known methods (BKMs) are in place to find High-NA relevant

stochastic patterning failures, such as hexagonal contact holes. In

addition, several machine learning techniques (based on denoising

SEM micrographs) will be proposed to facilitate the small defect inspection

and classification.

Finally, imaging improvements through source-mask optimizations

and anamorphic mask OPC (considering the need for stitching) will

be presented by imec and partners.

IMEC Belgium

3001 Leuven

Belgium


page 18/35

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NEWSLETTER | Edition EN 04-2024

page 19/35

Revolutionary cell therapy:

Restarting immune system switches

off autoimmune diseases

One single infusion with CAR-T cells

replaces immune-suppressive medicines

In March 2021, doctors from FAU treated a young woman with a

severe autoimmune disease with chimeric antigen receptor (CAR)

T-cells, the first time a treatment of this kind has been attempted

anywhere in the world. Today, nearly 3 years later, they were able to

publish a pilot study in the New England Journal of Medicine demonstrating

that CAR T-cell therapy can make various autoimmune

diseases disappear completely for a long period of time, waiving the

need for a further drug-based therapy.

“We believe that we have succeeded in finding the reset button

that works like with a computer to reboot the system and restart

the immune system without errors,” explains Prof. Dr. Georg Schett

(director of Department of Medicine 3 – Rheumatology and Immunology)

who conducted the study together with Prof. Dr. Andreas

Mackensen (director of Department of Medicine 5 – Hematology

and Oncology). The team pressed this “reset button” with 15 patients

with severe forms of autoimmune diseases, such as “red wolf disease”

(systemic lupus erythematosus), systemic sclerosis (also known

as scleroderma) and the autoimmune disease triggering inflammation

of the muscles known as myositis. One single infusion of cells

known as CAR T-cells from the patient’s own body manipulated outside

the body led to a resolution of chronic inflammation in organs

such as the heart, lungs and kidneys, in the joints and in the skin,

allowing patients to stop using immune-suppressive drugs such as

cortisone altogether for several years.

Treatment with CAR T-cells was made possible by using a special

cleanroom in Department of Medicine 5 at Uniklinikum Erlangen.

In this laboratory, the patients’ own immune cells are transformed

into therapeutic weapons (CAR T-cells). PD Dr. Michael Aigner

and his team from the GMP laboratory monitor the manufacturing

process of these living medicines and the quality of the cells before

they are returned to the patient. The CAR T-cells very effectively

attack pathogenic B-lymphocytes in the bone marrow, in the lymph

glands and in all other organs. Completely eliminating B-cells finally

leads to the disease being cured, as has now been demonstrated

very impressively with the publication in the New England Journal

of Medicine.

“It is particularly interesting that the B-cells return at some point

after treatment, but the disease does not,” explain Dr. Jule Taubmann

and Dr. Fabian Müller, who are part of the interdisciplinary team caring

for patients after treatment. The new B-cells in the patients are

naive “innocent” cells similar to those in a child, and no longer trigger

disease.

Further information:

These findings are a breakthrough in immunomedicine. It is already

possible for the CAR T-cell therapy to be used on further patients

with severe forms of systemic lupus erythematosus, systemic sclerosis

and myositis as part of the CASTLE study conducted at Uniklinikum

Erlangen. Anyone affected by one of these diseases can write to

Car-T-Cell.UKER@uk-erlangen.de.

Friedrich-Alexander-Universität Erlangen-Nürnberg

D 91054 Erlangen

Seven of the patients with autoimmune diseases who were successfully treated with CAR-T cells as part of the study. (Image: SIMOarts/Simone Kessler)


page 20/35

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page 21/35

Die Aussteller der LOUNGES 2024 in Karlsruhe


page 22/35

Stand 28.02.2024


page 23/35

Carl Zeiss Foundation Finances Establishment of Joint Facility

in Heidelberg, Karlsruhe, and Mainz

New Center for Synthetic Genomics

Applying and developing new technologies for DNA synthesis to pave the way

for producing entire artificial genomes – that is the goal of a new interdisciplinary

center that is being established at Heidelberg University, Karlsruhe Institute

of Technology (KIT), and Johannes Gutenberg University Mainz (JGU). The aim

of the Center for Synthetic Genomics is to spark new developments in synthetic

genomics through basic research and technology development using methods of

artificial intelligence. The Carl Zeiss Foundation (CZS) is financing the center’s

establishment over a period of six years with a total amount of twelve million

euros.

In the long term, it should be possible to design

and synthesize long DNA sequences for

applications in research, nanomaterials science,

and medicine. The first spokesperson

of the new center is systems biologist Professor

Michael Knop, Deputy Director of the

Center for Molecular Biology of Heidelberg

University (ZMBH).

While the past two decades of genome

research were marked by the development

of new genome sequencing techniques, it

will become possible to modify genomes

more quickly and easily, or even to create

entirely new genomes, using innovative

methods of DNA synthesis and genome assembly.

This is the vision that the Carl Zeiss

Foundation Center for Synthetic Genomics

Heidelberg – Karlsruhe – Mainz (CZS Center

SynGen) will pursue in the coming years.

The researchers from the three universities

want to design synthetic DNA sequences

with the aid of AI-based methods of analysis

and modeling in order to make targeted

modifications in the genome of organisms

and give it new functionalities. The aim is

to extract from them so-called biologics,

that is, biotechnologically manufactured

products. These are eventually to be used to

produce bio-based medicines, develop gene

therapies for diseases, breed pest-resistant

plants, produce biofuels, and advance research

into new types of materials.

“At the CZS Centers we consolidate

expertise across locations and disciplines.

The life sciences in particular require a high

degree of interdisciplinary collaboration. At

the CZS Center SynGen we aim to advance

the production of artificial DNA and tap

the immense potential for research, medicine,

and beyond,” says Carl Zeiss Foundation

Managing Director Dr. Felix Streiter,

explaining the motivation for funding the

f.l.t.r.: The three members of the Board of Directors Edward Lemke, Sylvia Erhardt, and

center spokesperson Michael Knop, as well as Phil-Alan Gärtig of the Carl Zeiss Foundation

(Photo: Uwe Anspach, Heidelberg University – Communications and Marketing)

second CZS Center in Germany.

“The Center for Synthetic Genomics

pools the expertise of three of the leading

research institutions, which are now jointly

working on an important future-oriented

field from basic research to technology development,“

says Professor Oliver Kraft, Acting

President of KIT. “Our aim is to achieve

a wide range of applications in biotechnology,

for example in medicine, but also in

materials science. We are very pleased to

contribute to this with our expertise.“

Synthetic Genomics

“Synthetic genomics is a young but rapidly

growing research area worldwide, with

transfer potential for different socially relevant

challenges. In our new center we will

pool the complementary expertise of the

three strong research universities at Heidelberg,

Karlsruhe, and Mainz in the life

sciences, molecular systems engineering,

and biomedical research. That way, we intend

to coordinate all the steps in synthetic

genomics, from design and production right

up to the application of synthetic genetic

materials and organisms,” says Center Spokesperson

Michael Knop. “The new center

will provide us with a unique opportunity

to combine different areas of expertise and

disciplines in a new way. Particularly the

discourse of biology and medicine with experts

in simulation and modeling will show

us new ways not only to generate synthetic

genomes, but also to better understand

and use natural and artificial modifications

and epigenetic mechanisms,“ Professor

Sylvia Erhardt explains. The molecular biologist

of Karlsruhe Institute of Technology

is a member of the CZS Center SynGen‘s

three-member Board of Directors alongside

Professor Michael Knop and biophysical

chemist Professor Edward Lemke of Mainz

University.

The Carl Zeiss Foundation Center for

Synthetic Genomics Heidelberg – Karlsruhe

– Mainz started work in January 2024.

Researchers collaborating at the three locations

represent different disciplines, including

biology, biochemistry, biophysics,


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biotechnology, synthetic biology, and bioengineering,

as well as philosophy and law,

genomics, immunology, epigenetics, virology,

and data science. In addition, more

international experts and early-career researchers

are to be recruited to work at the

new center. Furthermore, a competence

center for the synthesis of synthetic DNA

is to be set up in Heidelberg, the so-called

CZS Center Synthetic DNA Accelerator

Lab. Also involved in the CZS Center

SynGen are scientists from the German

Cancer Research Center and the Heidelberg

Institute for Theoretical Studies, as

well as external partners from science and

business.

The CZS Center SynGen was officially

opened with a festive event held at Heidelberg

University on March 4, 2024. In addition

to the lead researchers, representatives

of the Carl Zeiss Foundation and the participating

universities also took part.

About the Carl Zeiss Foundation

The Carl Zeiss Foundation’s mission is to

create an open environment for scientific

breakthroughs. As a partner of excellence in

science, it supports basic research as well as

applied sciences in the STEM subject areas

(science, technology, engineering, and mathematics).

Founded in 1889 by physicist and

mathematician Ernst Abbe, the Carl Zeiss

Foundation is one of the oldest and largest

private science funding institutions in Germany.

Karlsruher Institut für Technologie

D 76131 Karlsruhe

AMD’s Lisa Su honored with the

2024 imec Innovation Award

Imec – a global leader in nanoelectronics and digital technology research and innovation – is proud to announce that the

2024 imec Innovation Award will be presented to Lisa Su, Chair and CEO of AMD. The award ceremony will occur during

imec’s ITF World conference in Antwerp, Belgium on May 21 and 22. It will recognize Dr. Su’s contributions to driving innovation

in high-performance and adaptive computing.

Since its inception in 2016, the imec Innovation Award has become

a hallmark for recognizing pioneers in the semiconductor industry.

Past recipients include Dr. Gordon Moore and Bill Gates.

“It’s an immense privilege to welcome Lisa Su to this distinguished

group of industry luminaries,” said Luc Van den hove, CEO of

imec. “Since taking the helm of AMD in 2014, Dr. Su’s technological

acumen and visionary leadership have propelled the company to the

forefront of semiconductor technology development. Under her leadership,

AMD has become one of the most respected developers of

supercomputing chips – supporting the ever-evolving requirements

of the data center and gaming industries and fueling the emergence

of (generative) AI applications. This makes Dr. Su a truly deserving

recipient of the 2024 imec Innovation Award.”

Lisa Su, Chair and CEO of AMD, will receive the 2024 Innovation Award

at imec’s ITF World conference in Antwerp, Belgium.

“But equally important, Lisa Su is an outspoken advocate for the

role women can play in the semiconductor industry. The fact that

she actively encourages and empowers women to pursue engineering

degrees and rewarding careers in the field resonates deeply with

me. I therefore hope that this recognition will help inspire girls and

women to pursue their passions in STEM,” he added.

Before joining AMD, Lisa Su held various engineering and management

positions at companies such as Texas Instruments, IBM,

and Freescale Semiconductor. Notably, during her tenure as vice

president of IBM’s Semiconductor Research and Development Center,

Su made significant contributions to silicon-on-insulator semiconductor

manufacturing technologies and creating more efficient

microchips. In October 2014, she assumed the role of president and

CEO of AMD after joining the company in 2012, becoming the first

female CEO of a major semiconductor company.

Lisa Su holds a Ph.D. in electrical engineering from MIT. Her accolades

include being named ‘Executive of the Year’ by EE Times in

2014 and one of the ‘World’s Greatest Leaders’ by Fortune in 2017. In

2021, she became the first woman to receive the IEEE Robert Noyce

Medal.

“I’m honored to receive this year’s Innovation Award and be recognized

by imec for pushing the boundaries of computing. I am incredibly

proud of what we have accomplished together at AMD and

even more excited about the opportunities ahead to deliver innovations

that can help solve the world’s most important challenges,”

commented Lisa Su.

The award ceremony will take place at ITF World (May 21-22,

2024) in the presence of over 2,000 executives gathering at the Royal

Elizabeth Hall in Antwerp, Belgium.

IMEC Belgium

BL 3001 Leuven


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Packaging of medicinal products:

Which trends are important for

pharmaceutical producers and

machine manufacturers post-covid

Even after the Corona pandemic has subsided, the demand

for pharmaceuticals is increasing. But the requirements are

changing - and this has an impact on production equipment.

Machines for packaging medicines are not exempt

from this. And their manufacturers are only spurred on by

this.

Biopharmaceuticals are the real mimosas: heat, moisture, oxygen ingress

or simply just the wrong light can cause the sensitive drugs,

which are made from living organisms or cells, to lose their effect.

This became particularly clear in the Covid pandemic: the new

mRNA vaccines from Biontech-Pfizer and Moderna require sophisticated

packaging and logistics concepts to ensure storage temperatures

between -60 and -80 °C, for example. And although manufacturers

are working feverishly and also successfully on less sensitive

© AdobeStock/407222280/Rattanachat

active ingredients - packaging remains an essential element in the

fight against past and future pandemics.

The example of vaccines only highlights the importance of pharmaceutical

packaging. Every second new drug approved in the EU is

now produced using genetic engineering, is particularly sensitive to

environmental influences and must be packaged accordingly. In addition,

there are increasing regulatory requirements for production

technology, such as Annex 1 to Good Manufacturing Practice (GMP

guidelines), which was finalised in 2022: This will newly regulate the

sterile production and the filling and packaging of medicinal products

- with the aim of reducing contamination risks for the medicine.

Pharmaceutical market growing, machine market even stronger

No wonder, then, that the market for pharmaceutical packaging machines

is growing disproportionately - even more strongly than the

pharmaceutical market as a whole. Market researchers from Evaluate

Pharma, for example, expect the global pharmaceutical industry

to grow by 6 % annually to 1.6 trillion US dollars between 2022 and

2028. In parallel, the market for pharmaceutical packaging will grow

by 8.24 % and that for pharmaceutical packaging machines by 7.5 %

per year - according to the expectations of the market research company

Mordor Intelligence.

At the same time, the rising costs for filling, packaging and labelling

medicines are being met by declining revenues for pharmaceutical

manufacturers. After the vaccine boom of the Corona years, the

pharmaceutical industry is not only struggling with declining sales,

but also with the cost explosion due to the energy crisis. On the stock

exchanges, the market value of biotech companies has halved, while

at the same time the prices for inputs - including chemical precursors

- have risen significantly in 2022. The pharmaceutical industry

has come under particular pressure here because - as in the EU, for

example - it has to sell some of its products at a fixed price.

These and other trends are now also reflected in the enquiries

and specifications for packaging machines: Whereas in the past, for

example, filling and sealing machines with high output and lines

designed specifically for one drug were demanded, today the desire

for flexible lines that can be quickly - and if possible automatically -

converted to new products and other packaging formats dominates.

The trend towards smaller batches plays just as much a role here as

easier handling. It is noticeable that the desire for flexible production

processes is no longer only expressed by contract manufacturers,

so-called CMOs, but also by original manufacturers.

Flexible filling and packaging processes required

© AdobeStock/94397352/Kadmy

This development is clearly illustrated by the example of injectable


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preparations, the so-called injectables. Already in the years before

the pandemic, machine manufacturers had registered a strongly

growing demand for ready-to-fill syringes. The enormous demand

for vaccines in the Corona years 2020 to 2022 had recently caused

a revival of bulk packaging such as vials, but in the meantime the

share of „ready-to-use“ (RTU) syringes is rising again significantly.

With RTU syringes, for example, the medicine is filled directly into

a sterilised syringe. This not only reduces the risk of contamination

during preparation and administration, but also avoids dosing errors.

The customer‘s desire to find better packaging solutions for less

money is therefore driving the machine manufacturers. And one

keyword runs through the description of most new developments:

Flexibility. Syntegon, for example, has developed the Versynta flexible

filling system as a platform with which biopharmaceuticals

can be filled both in RTU syringes and in bulk packaging in the isolator.

To significantly reduce project times, supplier Groninger also

relies on flexibility with the Flexfill concept, but combines it with

standardised modules that are also housed in the isolator or RABS.

Bausch+Ströbel also relies on modularisation and has radically reduced

the number of format parts in the new CombiSys line. This makes

it comparatively easy to convert the machine from vials to RTU

packaging, for example.

New transport systems and digital technologies

Bausch+Ströbel kills two birds with one stone with a new magnetic

transport system that moves the packaging material through the machine:

In contrast to common drives, a fixed cycle time is no longer

required, which increases flexibility. At the same time, the magnetic

drive makes wipers and bellows seals unnecessary, thus eliminating

a cause of contamination in the sterile area. Optima has also addressed

the transport of packaging materials in the machine: With the

new FillCell formatless transport system, the main aim is to increase

product yield. Especially with expensive active ingredients, it is important

to avoid losses during machine start-up.

Machine manufacturers are taking this requirement into account

with new dosing and filling systems, but also optimised transport,

monitoring and labelling solutions. Digital technologies are playing

an increasingly important role here: this begins with training operators

with virtual reality goggles on digitised equipment, extends to

the seamless recording of production parameters in the production

process, and ends with the evaluation and visualisation of key figures

such as Overall Equipment Effectiveness (OEE), which are becoming

more and more important in the growing competition of the

pharmaceutical industry.

The Körber Group, for example, has dedicated itself to this topic,

using its Manufacturing Execution System (MES) to analyse

the operational efficiency of biopharmaceutical manufacturing processes

on the basis of different and previously unnetworked data.

Among other things, this should enable biopharmaceutical manufacturers

to significantly accelerate their time-to-market. Uhlmann

Pac-Systeme networks machines and entire plants of any manufacturer

via interfaces with a new software (Pexcite), thus enabling centralised

monitoring and control. In addition to looking at line efficiency

and planning set-up times, this also makes it easier to comply

with regulatory obligations.

Robots in glove-free isolator, scalable parenterals production

The automation strategy of many manufacturers now includes the

use of robots - not only at the end of the line, for example to stack packaged

medicines on pallets, but already in the sterile isolator. Machine

developers are benefiting from the fact that, on the one hand,

the range of cleanroom-suitable robots is steadily growing, while at

the same time the costs for robotics are continually falling. In this

way, automated solutions are increasingly replacing the otherwise

necessary gloved interventions on the isolator. This is because in the

demanding sterile production of high-quality medicines, human intervention

is increasingly being perceived as a nuisance and is being

replaced by technical solutions.

At the machine manufacturer IMA, the gloveless aseptic process

in the isolator is being promoted under the name „Injecta“. But the

machine manufacturers already mentioned are also pursuing the

trend towards aseptic filling without human intervention with their

own solutions. The development is consistently implementing the

requirements of the new GMP Annex 1. In many places, this also includes

dispensing with the time-consuming sterilisation of the primary

packaging material by using sterile packaging materials.

In general, the packaging of sterile preparations for injection and

infusion (parenterals) is very demanding, and the machine technology

is expensive. This becomes a problem especially when the success

of a drug and its required quantity are not yet known. The folding

box manufacturer Faller Packaging has developed a scalable solution

to this problem together with the machine manufacturer Schubert-

Pharma: This starts with the initially manual loading of pre-prepared

folding box packaging. As soon as demand increases, cobots are used

until the process is finally switched to a fully automatic top-loading

machine.

Sustainability becomes important

But it is not only the development of the processes around the primary

packaging of medicines that follows the new requirements of

the pharmacists. Developments in secondary packaging in folding

boxes, trays and cartons are not standing still either. In addition to

flexibility and product safety, important trends here are resource optimisation

and low CO2 emissions. This is because the topic of sustainability

is also increasingly finding its way into companies in the

pharmaceutical industry via CSR and ESG criteria.

In order to improve the recyclability of packaging, Uhlmann, for

example, is increasingly relying on packaging made of monomaterial.

With the Parenteral Tray Center, the manufacturer has recently

also introduced a flexible „direct-in-carton“ solution that can pack

ampoules, vials and syringes both in cardboard trays made of monomaterial

and in conventional plastic clamp blisters. Recyclable

packaging places new demands on machine manufacturers. Close

coordination between machine and packaging supplier is therefore

important. At Faller Packaging, for example, the approach is called

3R: Redesign, Reduce, Recycle: in addition to the use of new recyclable

mono-materials, this also includes testing existing products and

processes with the aim of minimising the use of raw materials and

energy.

But labelling technology is also evolving. While in the past decade

this was mainly characterised by the fight against counterfeit

medicines, other requirements are now coming to the fore with regard

to biopharmaceuticals. One trend here is the development of

new labelling solutions with sensor functions. The so-called „smart

labels“ use printable indicators that can be used to monitor the correct

storage of a medicine or the correct application temperature. If

the heat or UV light exposure of the medicine exceeds a defined value,

the indicator on the packaging changes colour. Another piece of

the mosaic to be able to safely control biopharmaceutical mimosas

in everyday life.

DECHEMA Ausstellungs-GmbH

D 60486 Frankfurt am Main


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World Premieres as well as Advancements in Sustainability and Efficiency

in the Spotlight

Very Good Signs for PaintExpo 2024

Preparations for the ninth edition of

PaintExpo are in the final stages, and

the signs for the world‘s leading trade

fair for industrial coating technology

from 9 to 12 April 2024 in Karlsruhe are

very good: Around 430 exhibitors from

Germany and abroad are expected.

The globally unique concentration of

companies from the coating technology

sector ensures a strong attraction

for users from contract coating companies,

in-house coating services and

all players in the coating technology

sector. The trade fair is the industry‘s

most important international platform

and visitors will have the opportunity

to experience numerous world premieres

and find out about technological

developments in sustainable and

energy-efficient coating processes for

the future.

Copyright: Leipziger Messe GmbH / Tom Schulze

Around 430 exhibitors - including the who‘s

who of the coating technology industry with

its market and technology leaders - will fill

three exhibition halls for four days at PaintExpo

2024 in Karlsruhe. The exhibitors at

the world‘s leading trade fair for industrial

coating technology will cover the full range

of products and services across the entire

supply chain. Over 40 per cent of exhibitors

are international. Most companies from

outside Germany are from Italy, Turkey and

Switzerland. However, the trade fair attracts

exhibitors from far beyond Europe and

companies from countries such as the US,

India and China are also represented.

„The signs for PaintExpo 2024 are very

good - despite the current challenging conditions.

We can already sense tremendous

excitement building for PaintExpo among

exhibitors and visitors alike. The world‘s

leading trade fair for industrial coating technology

will once again offer the industry the

perfect venue for holding in-depth technical

discussions, planning concrete projects and

making investment decisions. Visitors can

also expect to experience a wealth of innovative

product highlights at the exhibition

stands,“ says Markus Geisenberger, Chief

Executive Officer of Leipziger Messe.

Smart Solutions in Coating

One of the companies showcasing smart

solutions at PaintExpo in Karlsruhe is

WAGNER, exhibiting manual and automatic

spray guns with highly effective coating

performance and low material usage. WAG-

NER‘s new high-speed rotating atomisers

for solvents and water-based coatings play a

major role in implementing fully automated

wet-coating systems and robotic solutions.

The company has also made its pumps for

wet coating significantly easier to flush. The

Cobra high-press double diaphragm pump

has been optimised to significantly reduce

the amount of flushing agent and therefore

also the amount of time needed for changing

colours.

When it comes to powder coating,

WAGNER will be emphasising efficiency

and automation. In manual coating, the

focus will be on how the use of assistance

functions can help even inexperienced staff

carry out coating tasks in accordance with

requirements. Visitors to the company‘s

stand can also learn how to master the transition

to fully automated coating processes

using axis and robotic technologies.

Numerous World Premieres in Electrostatic

Powder-Coating Technology

At the Gema Switzerland stand, several products

are being presented for the first time.

The Swiss company‘s innovations include

a new series of automatic spray guns with

models for organic and enamel powders as

well as robotic applications. Gema will also

be showcasing new application pumps that

combine an advanced powder-loading technology

with the second generation of SIT

dense-phase powder delivery technology in

a single unit.

Furthermore, Gema is presenting a

fully automated powder management system

featuring an intuitive user interface

for switching colours efficiently. The system

also comes available with two powder

hoppers, allowing users to apply two different

colours one after another in rapid

succession.


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Innovative Technologies for

Sustainability and Efficiency

The range of products and services on

display clearly shows the extent to which

exhibitor awareness of the significance of

sustainability and efficiency in the coating

technology and production industries is

increasing. In line with this trend, POMA

Systems is introducing its i-GLUE automated

adhesive application system. By dosing

and applying adhesives precisely, this system

not only makes more efficient use of

materials but also optimises the quality of

the joints.

The exhibitor is also focusing on predictive

maintenance as a way of minimising

downtimes and maximising efficiency. Leveraging

sensor systems and data analysis

makes it possible to continuously monitor

machines so that problems can be identified

and fixed early on before the equipment

fails.

Experience Four Different Themes Up

Close at One Exhibition Stand

Axalta Coating Systems is likewise focusing

its trade fair appearance on a series

of products geared towards sustainability.

At the company‘s stand, four topics will be

highlighted. As part of its „Sustainability,

Together“ campaign, Axalta is presenting

its latest sustainable coating solutions with

a particular emphasis on biobased powder

coatings as an environmentally friendly alternative.

With a view to electromobility,

Axalta will also be showcasing coatings for

battery applications, including dielectric

and thermally insulating coatings.

Corrosion protection is also a major

theme. Multiple product lines including

thermoplastics, thermosetting primers, industrial

liquid solutions and their AquaEC

electrocoat products mean that customers

can select the right product for their needs.

Visitors to the stand can also look forward

to a ColourDesign area displaying the full

spectrum of colours available from Axalta.

Comprehensive Exhibitor Directory,

Tickets Only Available for Purchase Online

A number of exciting exhibitor innovations

can also be found in the digital exhibitor and

product directory on the PaintExpo website.

In addition, visitors can plan their time

at the trade fair in advance and on-site by

using an interactive map of the halls, creating

bookmarks lists and browsing the special

interest topics on sustainability, careers

and live experiences.

At the ticket shop on the event website,

visitors can purchase tickets for the trade

fair and redeem invitations from exhibitors.

The online ticket gives visitors fast and easy

access to the PaintExpo in Karlsruhe.

Leipziger Messe GmbH

D 04356 Leipzig

Andy Cowan Appointed as President,

Particle Measuring Systems

Andy Cowan has been appointed as President at Particle Measuring

Systems (PMS), taking over from Mark Fleiner, President Spectris

Scientific and Malvern Panalytical, who served as Interim President

at PMS starting July 2023.

Mr. Cowan‘s appointment marks a return to familiar territory,

as he previously held the position of VP for Finance and Business

Development at Particle Measuring Systems from January 2016 to

October 2018. Before this new role, he served as President of Servomex,

a sibling company to PMS. His career also includes significant

roles at Spectris PLC, the parent company of both PMS

and Servomex. Here, he was the Interim Business Group Director

and later the CFO of the ISD Division, bridging his experiences

between PMS and Servomex.

Amongst the many improvements under Andy’s leadership at

Servomex the company significantly improved on-time delivery,

achieved record sales, meeting profit expectations while also celebrating

Gold awards internally and externally for areas such as SBS/

Continuous Improvement, Health & Wellbeing and Sustainability.

“I am excited to be returning to Colorado and Particle Measuring

Systems. The company has great opportunities to grow and positively

impact clean manufacturing while also being a great place to

work,” said Andy.

“The combination of Andy’s industry experience and his ability

to positively impact business made him the easy choice for this position,”

said Mark Fleiner. He continued, “I have worked with Andy for

many years and look forward to seeing PMS grow and thrive under

his leadership as we work towards making the world cleaner, healthier,

and more productive.”

Particle Measuring Systems Germany GmbH

Im Tiefen See 45

D 64293 Darmstadt

Telefon: +49 351 88963850

eMail: PMSGermany@pmeasuring.com

Internet: http://www.pmeasuring.de


page 29/35

Blue Line expands in the Nordics

Blue Line is proud to announce that the company is expanding its presence in the Nordics with the launch of subsidiaries

in Norway and Sweden. This strategic expansion marks a significant milestone and will strengthen Blue Line’s connection

with customers and partners in these regions.

Strengthening presence in Norway and Sweden

Last year, Blue Line relocated its headquarters to a new facility to

ensure continuous delivery assurance, increased warehouse capacity,

and room for more resources in R&D and administration. This

expansion has created opportunities for further growth, resulting in

the establishment of new offices in Norway and Sweden, as well as

an expansion of the organization in Denmark to enhance engagement

with customers and partners in these regions.

Nils Olav Gjørvad and Lars Dammen lead Blue Line Norge AS, while

Lars Virdeby and Pontus Eriksson lead Blue Line Sweden AB. These

subsidiaries are fronted by highly experienced employees with solid

industry knowledge and Nordic cooperation knowledge, which will

contribute to a strong local presence and improved customer service.

Focus on improved customer service

and increased accessibility

At Blue Line, we are confident that this expansion will result in improved

customer service and increased accessibility. The goal is to

better and more efficiently meet customers‘ specific needs and requirements,

and the company believes that the new local offices will

significantly contribute to this purpose.

CEO, Niels Pedersen, says:

„Blue Line’s DNA has always been associated with a strong customer

focus, and with our new offices in Norway and Sweden, we have

opened the opportunity to better serve our customers within some

of the growing industrial and product areas. Therefore, shareholders

and management have decided to establish new offices in Norway

and Sweden, which will provide increased resilience in relation to

the growth we predict for the company. This will enable us to meet

the increasing demand for IT hardware solutions from both our current

and future customers. At the same time, we are creating the framework

for a more attractive workplace for an increasing number of

employees.“

Exciting new industrial and product areas

The expansion with our new offices in Norway and Sweden has

also opened up the opportunity to better serve our customers within

some of the growing industrial and product areas. This includes

areas such as Automation, Maritime, Transportation, Defense,

Telecom & Datacom. We look forward to serving customers in these

sectors and offering our expertise and solutions to these demanding

customers and markets.

Blue Line A/S

Kappa 8

DK 8382 Hinnerup

Phone: +45 8678 5000

email: NP@blue-line.com

Internet: http://www.blue-line.com


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From data glasses to robotic arms

– labs enter the digital age

The same developments happening in the rest of the world

are also reshaping laboratories: the increasing use of technology,

digital tools and, of course, robots and artificial intelligence

(AI). All these trends often go hand in hand with

a greater awareness of environmental issues. In this trend

report, we present a summary of the fruits these developments

are already bearing and will bear in the future.

The laboratory landscape is constantly changing. Whereas until the

middle of the 20th century people used their mouths to suck up

samples when pipetting, today‘s laboratories are equipped with the

appropriate technical aids to protect laboratory staff and make their

work easier. However, development has obviously not stopped with

pipettes and is now progressing rapidly, especially in the areas of automation,

digitalisation and robotics. We take a closer look at these

major laboratory trends and how they can also benefit sustainability.

In the beginning was automation

It almost seems like a relic of a bygone era: in the 1970s, as the third

industrial revolution (Industry 3.0) pushed the working environment

more and more towards automated processes. This led to an

increase in production output and created new opportunities in manufacturing

and engineering. At the same time, laboratories began

to move away from routine manual work towards more mechanical

support. However, it was not until the Fourth Industrial Revolution,

in the wake of digitalisation, that the formal breakthrough occurred.

Since then, progress in this area has been promoted and discussed

under the buzzword Laboratory 4.0.

The combination of basic tasks such as stirring, tempering, dosing,

etc. in automated processes laid the foundation for faster and

more repeatable laboratory work. Nowadays, virtually every piece of

laboratory equipment is at least partially automated – from the HPLC

system with pump unit and autosampler, to the fermenter with precisely

controlled temperature technology and media supply, to the

electronic pipette with support function for predefined workflows.

When we talk about automation in the laboratory today, it is inextricably

linked to digitalisation. „It is important to remember that

digitalisation alone is not enough – especially in the laboratory, automation

also includes a strong hardware component,“ says Prof. Dr

Kerstin Thurow from the Centre for Life Science Automation (CELI-

SCA) at the University of Rostock. Without suitable equipment and

systems for handling samples and labware, she says, it is not possible

to automate laboratory processes. „This is often overlooked or taken

for granted in today‘s discussion,“ she notes.

Ideally, a device combines automation and digitisation, as many

workstations do. These devices are usually equipped with their own

software that allows users to save their own workflows without the

need for programming skills. For example, pre-defined steps can be

dragged and dropped into the system to develop drug screens on a

PC, which are then automatically performed by a pipetting station.

This gives users more time for complex laboratory tasks such as

planning and evaluating experiments.

From automats to auto-arms

In addition to workstations, which usually fulfil a narrowly defined

task, robotic arms, familiar from industrial applications, are increasingly

being used in the laboratory. „In addition to classic Cartesian

liquid handling robots, various types of robotic arms are used when

highly complex systems consisting of several devices need to be

connected,“ explains automation expert Thurow. This type of robotic

arm, which is most commonly associated with automotive manufacturing,

can perform flexible movements that would otherwise

only be possible by a human arm – and it can do so with the precision,

endurance and repeatability of a machine. This is useful for

sample transfer or preparation, for example, and particularly in project-based

environments where workflows and tasks change more

frequently and require a more flexible solution.

To accommodate a robot assistant in the laboratory, which is

usually already constrained by a lack of space, modern robot arms

© shutterstock/586533194/Kitreel © iStock/1140779713/gorodenkoff


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© iStock/1358567925/PeopleImages

© iStock/1298111593/Eplisterra

are usually so-called cobots, short for collaborative robots. Their advantage

is that they can be safely integrated into a shared workspace

with a human, without the need for physical separation.

It is conceivable that in the future, robotic assistants will take

over simple and tedious tasks from laboratory staff. „Kevin“, an autonomous

cobot developed by the Fraunhofer Institute for Automation

Technology, is already in use in real laboratories. This cobot moves

independently around the laboratory, taking samples and transporting

them between the reception area, the analysis laboratory and the

archive. According to automation expert Thurow, this type of mobile

robot has the best chance of fundamentally changing laboratory

work in the future. „It will further increase the degree of automation,

especially in highly complex distributed systems. However, she believes

that there will never be a fully autonomous laboratory. „Solutions

will always be tailored to specific processes,“ says Thurow.

Flood of data

Apart from the physical tasks performed by robots and other machines,

data generation is usually the main focus, or at least an essential

part of the work, in the laboratory context. Since the beginning of

the computer age, we have seen a rapid increase in the speed and

volume of data generated.

This has inevitably been accompanied by the development of

tools to assist laboratory staff in the acquisition, maintenance and

analysis of data. These include laboratory information and management

systems (LIMS), which would probably not exist without the

growing flow of data. These systems help with documentation, sample

management and act as an interface to the various instruments

used in the laboratory. This makes process and sample traceability

easier or possible, allowing accredited laboratories to comply with

regulations at a reasonable cost.

Communication is key

In general, interfaces are an extremely important issue in the laboratory

world. For some time now, there have been efforts to put an end

to the days of proprietary software and to enable the much-vaunted

„plug and play“ capability across different manufacturers without

any restrictions – in other words, simply plug in a new spectrometer

and it is immediately recognised in the existing laboratory network

and ready for use. Although this is already happening in many cases,

there is still much to be done. The two initiatives SiLA and OPC UA

LADS are particularly noteworthy in this respect. Both aim to create

a common standard for instrument connectivity in the laboratory.

One reality is not enough

When it comes to the usability of a new or first-time laboratory setup,

it is not just the question of interfaces that comes into play, but

also general planning aspects such as the sensible location of equipment,

the space available and even the complete planning of media

supply and the set-up of new workstations. Virtual reality (VR) has

already gained a foothold in the laboratory sector. For example, a

pre-created digital twin of the laboratory can be explored interactively

and immersively, laboratory furniture can be placed and modified,

and users can discuss and visualise changes with the laboratory

planners in the virtual space. This transforms traditional site visits

into meetings that can be held from anywhere by simply logging in –

provided there is a stable internet connection.

A related technology, Augmented Reality (AR), superimposes

digital information on the user‘s view of the real world. This technology

has great potential to improve the quality of work in the laboratory,

although it is still a long way from being used in everyday

work. The possibilities are endless: step-by-step workflows guided

by text displayed in data glasses, highlighting of required equipment

or chemicals in the field of view, or repair instructions for an analytical

instrument are just a few examples. Users may still have to get

used to this form of assistance. It is conceivable that this technology

will soon become socially acceptable in the wake of Apple‘s recently

introduced VR glasses.

When machines start to learn

The emergence of the ChatGPT chatbot and its clones, which have

generated a huge media hype in a very short time, shows how quickly

a technological leap can take place. The possibilities offered by such

learning algorithms will also change the world of laboratory work. A

suitably trained programme could, for example, help with documentation

and writing publications. Or it could simply act as an intermediary

between humans and computer programmes, allowing them to

design and control measurements via text or voice input – in direct

dialogue with the analytical instrument, so to speak. In 2022, Lauda,

the manufacturer of temperature control technology, made its first

attempts at voice control for the laboratory with its Lauda Live system.

The advantage is obvious: manual data entry is no longer necessary,

leaving the hands free for other tasks.

The green lab of the future

Laboratories will gradually become more connected, digitalised and


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automated. In the future, we may even achieve the much touted ‚paperless

laboratory‘ – although in some cases we are still some way

off. However, there is one aspect that seems to be the counterpoint

to all this technological progress that will have a decisive influence

on the laboratory of the future: the issue of sustainability.

The desire for a more sustainable laboratory is by no means

synonymous with a desire for less technology, but rather relies on

new technologies. Dr Thorsten Teutenberg of the Institute for Environment

and Energy, Technology and Analytics (IUTA) confirms

this: „Initially, digitalisation offers the greatest potential for advancing

sustainability in the laboratory.“ According to Teutenberg, this

is due, for example, to better organisation and documentation. „In

many academic institutions, experiments are often repeated that

have already been carried out several times, but by a different person

who may not have worked at that institution for a long time. By using,

for example, an electronic lab notebook instead of a paper-based lab

notebook, research results can be made permanently available and

unnecessary experiments can be avoided“.

Another positive side-effect in terms of sustainability is the miniaturisation

of laboratory equipment and processes, such as switching

from classic HPLC to micro-LC. Such modifications ideally

free up valuable space in the laboratory. „If we can save space by

miniaturising analytical systems, this has a direct impact on the running

costs of the laboratory,“ explains Teutenberg.

Miniaturisation of equipment and experimental set-ups down to

lab-on-a-chip for minimal resource consumption, an AI-optimised

reaction approach that achieves the desired result faster, or simply

a freezer with lower energy consumption – many modern developments

implicitly support the idea of sustainability in the laboratory.

Bottom line

From automation and robotics to digitalisation, AI and greater sustainability:

Laboratories are in a constant state of flux. How quickly

the laboratory world actually changes depends not only on the advancement

of these technologies, but also on the people who use

them in their daily work. And sometimes it takes a while for something

new to catch on, whether it‘s the first LIMS or futuristic-looking

AR data glasses for labs.



Raumedic Announces Membership in the

Bio-Process Systems Alliance (BPSA)

Raumedic, a global leader in the development and manufacturing of polymer-based components and systems for the medical

and pharmaceutical industry, is now a member of the Bio-Process Systems Alliance (BPSA) . This step aligns with

Raumedic’s strategic commitment to serve the biopharmaceutical and biotech sectors as a supplier of single-use fluid management

equipment.

BPSA is an international non-profit organization

led by industry experts spanning

the entire value chain of bioprocessing. The

global association strives to advance the

global adoption of single-use technology in

bioprocessing, aiming to realize this mission

through educational initiatives, best practice

sharing, consensus guideline development,

and fostering networking opportunities.

“Joining BPSA reflects our commitment

to leading the future by staying at the forefront

of industry standards, ensuring our

single-use solutions align with the latest

advancements and regulations of the industries

we serve”, says Stefan Seuferling, CEO

of Raumedic AG.

Mark A. Petrich, Chairman of the Board

of BPSA, is glad to welcome Raumedic as a

new member of the organization: “We are

excited to announce Raumedic as a new

member of our global alliance. We recognize

the valuable perspective that the German

company brings to our organization and its

members – especially with their expertise in

polymer-based solutions such as single-use

sets and tubing.”

Raumedic’s interest in joining BPSA is

also based on recent activities to deepen its

service to the biopharmaceutical industry -

serving as a reliable and safe one-stop-shop

for polymeric single-use products.

Last year, Raumedic launched a new

brand for biocompatible single-use bioprocessing

tubing. Leveraging more than 70

years of polymer processing expertise, the

company decided to end its exclusivity as a

supplier of a single major life science client -

and offer its single-use solutions to the entire

market for the first time.

Raumedic AG

D 95233 Helmbrechts


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ACHEMA 2024:

Multifaceted lecture programme

for the world of the process industry

ACHEMA 2024 will once again fully integrate the lecture and supporting

programme with the exhibition. In 2022, ACHEMA integrated

the congress and the so-called Innovation Stages into the exhibition

for the first time. Due to the positive feedback, the concept

will be continued this year. In total, more than 750 presentations

await visitors in the lecture halls and on the stages in the exhibition.

“Science and Industry in Dialogue has always been DECHEMA‘s

credo and since the last ACHEMA it has also been a living practice

in the lecture and congress programme. The success proves us right:

With more than 20,000 listeners, the number of attendees in 2022

was significantly higher than at ACHEMA 2018, which had more

participants overall,“ says Dr Andreas Förster, Executive Director of

DECHEMA e.V. and thus organiser of ACHEMA. This year‘s congress

programme focuses on the topics of hydrogen, sustainability,

circular economy and digitalisation. At the six Innovation Stages

in the exhibition and in the five highlight sessions of the congress,

ACHEMA 2024 will address these and other top topics of the process

industry.

Process Innovation

The GEA Process Innovation Stage in Hall 9.0 will focus on topics

such as electrification, flexibilisation and biotechnologisation of chemical

processes as well as contributions to smart digital technologies

in plant construction and operation. In the Process Highlight Session

„Nature as a role model – maximum resource efficiency in the chemical

industry“, experts will discuss the vision of a fully resource-efficient

chemical industry and its implementation. The highlight session

will take place on Friday, 14 June 2024 from 12:00 to 13:00.

Pharma Innovation

The ZETA Pharma Innovation Stage in Hall 4.1 will cover biopharmaceutical

production in addition to many other topics related to

pharmaceutical production and packaging, which is also the focus of

the Pharma Highlight Session on Monday, 10 June 2024 from 13:00

to 14:00: Under the title „Next generation pharma manufacturing –

current advances in cell and gene therapy“, the Pharma Highlight

Session will have a closer look on the centralised and decentralised

production of cell therapeutics and the current challenges of translational

research and the marketing of therapies.

Lab Innovation

More than ever, success in the laboratory is determined by the technologies

used in the laboratory and at the interfaces to engineering

and production. This is the focus of the presentations on the Lab Innovation

Stage in Hall 12.0. In addition to the Lab Innovation Stage,

ACHEMA 2024 will also feature an action area dedicated to the digitalised,

miniaturised and automated laboratory of the future. Besides

innovative bioanalytics and (bio)pharmaceutical applications, sustainability

as well as the planning, construction, equipment and operation

of laboratories will also be highlighted. The latter is a particular

focus in the SEFA Theatre of the Scientific Equipment and Furniture

Association: at ACHEMA, it is the contact point for laboratory operators,

architects, users and experts from the laboratory community

who want to find out more about the laboratory-grade environment

and gain insights into successful examples from around the world.

Green Innovation

The challenge of climate-neutral production in the process industries,

the circular economy, the integration of molecular and industrial

biotechnology, sustainable innovations and investments – these are

the topics that are the focus of the EY Green Innovation Stage in Hall

6.0. “The chemical industry is looking to innovative technologies to

bolster sustainability, such as green chemistry and circular economy

practices. ACHEMA is a key platform for bringing industry experts

together to address these challenges and foster innovation”, emphasises

Matthias Brey, Head of Sustainability Consulting Europe West at

EY. In the highlight session „Beyond fossil fuels – exploring alternative

carbon sources for a sustainable chemical industry”, on Thursday, 13

June 2024 from 13:00 to 14:00, experts from science and industry will

discuss how fossil-free production can become a reality.

Digital Innovation

Industry 4.0, artificial intelligence, autonomous systems, digital

twins and, last but not least, cybersecurity: The Siemens Digital

Innovation Stage in Hall 11.0 offers a comprehensive and practical

overview of key digital trends and their use in the process industry.

“For the process industry, ACHEMA is the key platform where innovation

and practical application come together. We will show how

Siemens is connecting the real world with the digital world to create

a more sustainable future for our customers“, says Axel Lorenz, CEO

Process Automation at Siemens. The highlight session „Artificial

intelligence and autonomous systems in the process industry“ on

Wednesday, 12 June 2024 from 13:00 to 14:00 will discuss the steps

towards autonomous systems and explore the technological and cultural

challenges that lie ahead.

Hydrogen Innovation

The process industry stands like no other sector for the technological

backbone of a functioning hydrogen economy: The Siemens

Hydrogen Innovation Stage in Hall 6.0, the Special Show Hydrogen


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and numerous other exhibitors at ACHEMA will present the milestones

of the hydrogen economy to date as well as future challenges.

The highlight session „Hyperscaling hydrogen – turning strategy into

reality „ on Tuesday, 11 June 2024 from 13:00 to 14:00 will deal with

the central questions of the hydrogen ramp-up: What does hyperscaling

mean for plant engineering, its suppliers and users? What

investments and partnerships do we need for technology development

and infrastructure?

All highlight sessions will take place

in the room Europa in Hall 4.0.

While the congress sessions will primarily focus on applicationoriented

research and the development from proof-of-concept to

the threshold of market entry, the Innovation Stages will focus on

current production issues, best practices and ready-to-use technologies

via short presentations – always with application in mind.

With the exhibition and the closer integration of the various components,

ACHEMA will offer a complete 360-degree perspective

on all trends and technologies in the process industries. The lecture

programme is therefore an important reason why experts and users

from 130 countries will once again be coming to ACHEMA in Frankfurt

this year.



Roadshow puts productivity on the map

Something huge is making its way around Europe over the next four months!

Sumitomo (SHI) Demag presents to customers its first ever supersized roadshow

truck. A 20 metre long mobile exhibition space containing all of the latest injection

moulding technologies and timesavers that promise to put plastic processors

on the fastest path to increased productivity and higher operating profits.

Starting at the company’s headquarter in

Schwaig, Germany on 8 April, 2024, the 40

ton #NextStopProductivity truck will then

set off on its European tour. Covering 14

countries in four months, at each of the 25

stopovers local country experts will present

to their customers a fully-operational allelectric

IntElect injection moulding machine.

Several of the company’s latest digital

solutions that deliver greater processing

transparency and increased machine availability

will also be demonstrated.

Citing customer convenience and sustainability

as the rationale for organising this

touring exhibition, CEO Gerd Liebig elaborates:

“Our inaugural 2024 roadshow means

that processors no longer need to commit

to travelling to a trade show. Instead, we

are bringing processors, managers, maintenance

and industry experts all together at

central locations in each respective country,

with our local teams each hosting customer

events, presentations and machine demonstrations.

“As well as being less disruptive to

businesses, this touring approach reaches

more professionals, making it the more convenient

travel option for everyone,” points

out Mr. Liebig.

The unique roadshow event will demonstrate

to customers exciting and more

profitable ways to optimise production processes.

Equipped with a 25mm screw and a

2-cavity tool, processing PP, visitors to the

travelling expo will see first-hand the instant

IntElect efficiency benefits. HB-Therm

provides with the Thermo-6 the appropriate

temperature control unit for the application.

Users can then explore how to fully utilise

features to repeatably increase cycle times

and make even more components at less

cost to their business and the environment.

“Optimising productivity and improving

TCO are gamechangers for processors, even

more so during these challenging times.

Being more competitive also requires wellinformed,

trained personnel. Our live demos

will explore a range of operational-enhancing

topics. Including minimising machinery

downtime, increasing output, identifying

the most efficient ways to process recycled

and regrind materials, and leveraging the

advantages of engaging your teams through

training,” expands Mr. Liebig.

The planned route covers Italy, Spain

and France. In May, the tour arrives in Austria,

Germany, Hungary, Slovakia, and the

Czech Republic. Poland will host four successive

events in early June, with the truck

then heading to The Netherlands, Belgium,

and back through Germany and France. The

final four calling points will be in Ireland,

Scotland and the UK.

Sumitomo (SHI) Demag

D 90571 Schwaig

Impressum:

cleanroom online / W.A. Schuster GmbH · Mozartstrasse 45 · D 70180 Stuttgart · Tel. +49 711 9 64 03 50 · Fax +49 711 9 64 03 66

info@reinraum.de · www.cleanroom-online.de · GF Dipl.-Designer Reinhold Schuster · Stgt, HRB 14111 · VAT DE 147811997

Original texts and images

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