Newsletter_06-2024_EN

EN 06/24

COSINUS: New experiment

tests controversial

dark matter signals

TITLE

In the clean room: Karoline Schäffner and her team complete

their work on the cryostat. (Photo: COSINUS Collaboration)

A team of scientists and technicians are

installing the cryostat. (Photo: COSINUS

Collaboration)

COSINUS: New experiment tests

controversial dark matter signals

The detector: A crystal of

sodium iodide - the same

material as in the DAMA/LIBRA

experiment. (Photo: COSINUS

Collaboration)

On April 18, 2024, a large-scale experiment to detect dark matter was inaugurated in Italy. COSINUS is an international

research project in which a team from the Max Planck Institute for Physics (MPP) is also involved.

The nature of dark matter is still one of the great questions of modern

physics. According to current knowledge, invisible dark matter

accounts for 85 percent of the total mass in the universe. The CO-

SINUS* experiment goes into operation today at the Italian INFN

Gran Sasso National Laboratory. The research project is intended to

test whether another experiment (DAMA/LIBRA) has actually measured

signals of dark matter - or not. COSINUS is a collaboration

between the Vienna University of Technology, the Institute for High

Energy Physics of the Austrian Academy of Sciences, the National

Institute of Nuclear Physics (Italy), the Helsinki Institute of Physics

(Finland) and the MPP.

The nature of dark matter is still one of the great questions of

modern physics. According to current knowledge, invisible dark

matter accounts for 85 percent of the total mass in the universe. The

COSINUS* experiment goes into operation today at the Italian INFN

Gran Sasso National Laboratory. The research project is intended to

test whether another experiment (DAMA/LIBRA) has actually measured

signals of dark matter - or not. COSINUS is a collaboration

between the Vienna University of Technology, the Institute for High

Energy Physics of the Austrian Academy of Sciences, the National

Institute of Nuclear Physics (Italy), the Helsinki Institute of Physics

(Finland) and the MPP.

For the COSINUS project, a specialized instrument has been

developed in which a crystal is cooled to extremely low temperatures

to measure the energy of particles accurately. If the universe

is indeed filled with dark matter consisting of previously

unknown particles, then Earth should collide with these particles

as it moves through space, and the instrument could detect these

collisions.

The DAMA/LIBRA experiment has collected data that is consistent

with this assumption, although it is controversial as it has not yet

been confirmed by another experiment.

Is the Earth plowing through a nebula of dark matter?

If dark matter could actually be detected, the measurements would

vary throughout the year. Why? The sun and all its planets - including

the earth - move around the center of the Milky Way at a speed

of around 220 kilometers per second. The Earth, on the other hand,

orbits the sun at a speed of around 30 kilometers per second, taking

one year to complete a full orbit. This means that the Earth moves

in the same direction as the sun for half a year and in the opposite

direction for the other six months.

„If our galaxy is permeated by particles of dark matter, the Earth

would move through this ‚fog‘ sometimes faster, sometimes slower,“

explains MPP scientist Karoline Schäffner, technical director of CO-

SINUS. „The situation is like driving a car in the rain: The faster we

drive, the more raindrops hit the windshield. So, we expect to detect

different amounts of dark matter at different times.“

This is exactly what the DAMA/LIBRA experiment, which has

been running since 1995, has shown: A signal was actually detected

whose intensity changed regularly over the course of the year - an

indication of dark matter. However, other experiments were unable

to repeat these results.

The lack of evidence from other experiments has kept the international

research community busy for years. „Our new project gives

us the chance to solve this puzzle,“ says Karoline Schäffner. „We

are using sodium iodide in our detector, the same material as in

the DAMA/LIBRA experiment, in order to be able to compare the

results. However, our experimental setup will achieve significantly

higher accuracy.“

Heat and light

The DAMA/LIBRA experiment only measures light, not heat. There

www.reinraum.de | www.cleanroom-online.com NEWSLETTER | Edition EN 06-2024

page 2/36

Set-up of the COSINUS experiment

(Drawing: COSINUS Collaboration)

are already two other experiments with which scientists are

working to reproduce the DAMA/LIBRA experiments. Like

the original, both only record light - unlike COSINUS, which

is designed for two different signals.

At the heart of COSINUS is a cryostat - a kind of refrigerator

for extremely low temperatures - in which a crystal of

sodium iodide can be cooled to 1-2 hundredths of a degree

above absolute zero (- 273 degrees Celsius). If this crystal is

hit by dark matter particles, two reactions occur in the detector:

Firstly, the atoms of the crystal are set into vibration

- the crystal lattice begins to wobble and heats up. The heat

energy absorbed in the process can be measured extremely

accurately. Secondly, light is also produced in the crystal,

which COSINUS can also „see“.

Known or unknown particles?

The investigation of two signals also provides clues as to

which particles are involved. „This is important because not

every signal that is measured in such a detector is an indication

of dark matter,“ explains Karoline Schäffner: „For example,

it could be ordinary electrons that are produced by natural

radioactivity. Or neutrons produced by cosmic particles.“

In order to detect dark matter signals, the researchers

have to shield the crystal as effectively as possible from any

background noise. This is why the experiment is well protected

in a mountain massif, in the largest underground laboratory

in the world: the Gran Sasso National Laboratory (Italy),

around one hundred kilometers from Rome. Under 1,400

meters of rock, a tunnel system provides space for a large

number of highly sensitive experiments - the DAMA/LIBRA

experiment is also set up there. The detectors are also placed

in a seven-metre-high tank of ultra-pure water.

The COSINUS project will open in the Gran Sasso National

Laboratory on April 18, 2024. The first results of the

measurements are expected in 2025/26.

June 2024

Dear cleanroom professionals,

For Catholics, May was something of a test for the

4-day week: a public holiday every week and then,

to make matters worse, additional bridging days

to be planned. How is anything supposed

to get done?

According to Statista, real wages rose by an

average of 3.8% in the first quarter. The biggest

increase was in administration with +9.1%.

An increase in output of just under 10% would

not have been bad either.

In return, we have once again achieved

something: a comprehensive newsletter with

many interesting articles:

> COSINUS: New experiment tests

controversial dark matter signals

> Is there anything missing in the

new Annex 1? From hands disinfection

to rapid microbiology

> Sustainable purity for demanding production

processes

> Germany‘s only metal-free clean room

laboratory for the geosciences opened

at TUBAF

> Process simulation enhanced by realistic

cost calculation

> . . .

With kind regards

Reinhold Schuster

* Cryogenic Observatory for SIgnatures seen in Next-generation

Underground Searches

Max-Planck-Institut für Physik

D 85748 Garching


page 3/36

An interview with Tim Sandle (Interview by Cristina Masciola, AM Instruments)

Is there anything missing in the

new Annex 1? From hands disinfection

to rapid microbiology

The highest risk within a cleanroom is personnel. Despite this, the new Annex 1 seems to give not enough attention to such

an extremely delicate operation as gloved hand disinfection. Human error, its imponderability, and especially the absence

of traceability make this a high-risk operation. What is your opinion about this “lack” within the new Annex 1?

Hand disinfection is essential for aseptic working.

The essential elements are:

– Frequency

– Coverage

– Time

– The correct disinfectant

With frequency, gloves need to be disinfected before and after each

aseptic operation (with the additional requirement in Annex 1 to

change gloves after an intervention, one finger dabs have been taken).

It is also important that personnel perform regular glove sanitisation,

such as every 10 to 15 minutes even when idle.

With coverage, the application technique is important. The volume

should be standardised and it should be sufficient to cover all

parts of the glove. The technique used to rub the disinfectant (which

is normally 70% IPA) across the palm and fingers is important and

this should be well practiced.

In terms of time, as with other forms of disinfection, the contact

time is important. Studies show 15 to 30 seconds is necessary to

reduce the typically maximum levels of bioburden found in a cleanroom

environment.

In gloved hand disinfection, the risk of cross-contamination can

be averted through the use of automated devices with specific

characteristics. What are they?

There are devices on the market that can make the hand disinfection

process more reliable. Such devices, which can also digitally capture

data, can control the quantity of disinfectant dispensed and time

how long the employee spends undertaking the glove sanitisation

step.

In addition, devices can also indicate the expiry of the disinfectant

and warn when the solution is running out.

Another advantage is that devices that be position close to where

they are needed, to make access convenient for personnel and

avoid the need to criss-cross too often, helping with the logical flow

which is needed to underpin aseptic operations.


page 4/36

However, even with sophisticated automated devices, personnel still

need to be trained in the importance of glove sanitisation and with

sanitising their hands at the appropriate time point.

Traceability of hand disinfection is not required in any

regulations. Doesn’t this seem a contradiction to the very

meaning of the Contamination Control Strategy?

Traceability can be useful for the quality assurance assessment and

to provide reassurance for the production manager. This is another

area where digital technology can be advantageous. Devices can record

how often an individual operator accessed a hand sanitisation

station. This can be important to verify, for example, that hands were

disinfected prior to performing interventions, as an example.

In the light of your experience, are there, in your opinion,

any topics that the new Annex1 has left out or dealt with

ambiguously but that you consider essential for maintaining

sterility in drug manufacturing?

In terms of things that are missing, the Annex 1 makes many references

to ‘risk’ but very few to hazards. Hazards are the elements that if

they are sufficiently likely and sufficiently severe, they will lead to

unacceptable risks. I think this places the Annex out of alignment

with ICH Q9, where ‘hazard identification’ is the important step in

order to undertake a risk assessment. This is especially so with ICH

Q9 having recently undergone an update to introduce more formality

into the risk management process.

With environmental monitoring, while finger dabs and gown

plates are now included, swabs remain missing from the text. This

makes little sense as swabs are required for narrow and irregular surface

monitoring and for sampling critical surfaces like filling needles.

Annex 1 states that environmental monitoring sampling methods

and equipment used should be fully understood, with the recovery

efficiency of the sampling methods chosen qualified. I prefer: “The

recovery efficiency of the sampling methods should be understood.”

This is because ‘qualified’ brings with it a level of analytical method

validation that becomes challenging for imprecise methods.

For cleanrooms, the minimal differential pressure is defined for

adjacent cleanrooms of different grades. However, a minimal air exchange

rate for clean rooms is no longer quoted in the text. While

this is connected to energy saving, I think that a minimal standard

should continue to be set. The old guidance of ~20 air changes provided

a point of guidance.

There are some issues that have been downplayed trough the

different drafts and towards the publication of the final version of

the Annex. For example, there was a greater focus on separative devices,

especially with isolators. The importance of separative devices

and exclusion personnel should be given more focus in my opinion.

It was also disappointing that the emphasis upon rapid microbiological

methods was less strong. As an industry we need to be

pursuing better ways to verify the robustness of our contamination

control strategy (and in real time).

There is also some ambiguity, such as with many references to

“ampoules and vials“. I think the term “primary packaging containers”

is better, with a definition. This would acknowledge forms of

processing like bow-fill-seal and include any other containers in addition

to ampoules and vials, as well.

In the personnel section I questioned the portion of the text that

states shoes should be disinfected – I do not think the disinfection of

shoes would pass a disinfectant efficacy test; instead I’d recommended

the use of captive shoes.

Another ambiguity is with process validation; this could be scoped

out. The term process validation is often understood as manufacturing

process validation but should be enlarged to all relevant

processes in this context. I’d recommend: “process validation including

manufacturing, cleaning, decontamination sterilization, transport.”

For personnel movement, with “The use of separate change

rooms for entering and leaving the grade B area is desirable.” I support

separate routes, but I felt that ‘desirable’ was too vague a term.

There were other areas where I think we need tighter language.

With disinfection, the confusing reference to ‘resistant strains’

remains. Here the phrase ”development of resistant strains “is often

misinterpreted as development of acquired resistance (a theory

which has largely been discredited). We assume the intention of this

sentence is to draw attention to recovery of organisms with innate

resistance. I’d proposed that the word development be deleted “development”,

so that the text changes to read: ‘‘Monitoring should be

undertaken regularly in order to show the effectiveness of the disinfection

program and to detect the recovery of resistant and/or spore

forming strains.”

In terms of water sampling, the Annex states that users should

ensure that at least one representative sample is included every day

of the water that is used for manufacturing processes. This could be

tightened. I felt that for WFI systems a sample at the end of the distribution

loop each day that the water is used should also be sampled

and tested.

Although I have made some points of criticism, it remains that

Annex 1 is a good document and it is a step forwards. The Annex 1 directs

us to embrace a holistic, proactive and risk based methodology

based on process understanding and risk knowledge and a Quality

Risk Management (QRM) approach to contamination control that

requires documenting in a CCS.

AM INSTRUMENTS

Via Isonzo, 1/C

IT 20812 Limbiate (MB)

Telefon: +39 02 8728421

eMail: info@aminstruments.com

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


page 5/36

Sustainable purity for

demanding production

processes: Coherent Laser-

Systems relies on ENGIE Deutschland

© ENGIE

Deutschland

– ENGIE Deutschland is implementing a highly complex cleanroom solution for laser manufacturer

Coherent LaserSystems at its Lübeck site, which will send a signal to the entire industry

– In the cleanroom with a total area of more than 3,000 square meters, the specialist for technology,

energy and service ensures reliable functionality

– ENGIE Deutschland and Coherent LaserSystems meet the highest standards of economy, efficiency

and sustainability with this technically sophisticated concept - thanks to the photovoltaic system

and waste heat recovery, among other things

In the laser industry, working with particle-sensitive components is

the order of the day - and even minimal deviations in the size and

concentration of particles can have a significant impact on the quality

and functionality of products. Coherent LaserSystems GmbH &

Co KG, a leading global provider of lasers and photonics solutions, is

therefore relying on the expertise of ENGIE Deutschland GmbH for

reliable clean room conditions: in collaboration with Siemke & Co

Brücken- & Ingenieurbau (SBI) as general contractor, the specialist

for technology, energy and service is responsible for the construction

of a production facility for laser systems at the Lübeck site, north

of Hamburg. The property comprises around 2,600 square meters of

cleanrooms and a further 1,900 square meters for potential cleanroom

expansion, 1,100 square meters of laboratory space and more

than 3,750 square meters of office, storage and technical space.

Maximilian Busch, Head of Sales & Engineering in the Building

(Copyright: © PSP Architekten Ingenieure )

Technologies business unit at ENGIE Deutschland, says: „Cleanrooms

have special requirements in terms of personal, product and

environmental protection. We at ENGIE Deutschland are proud to

have implemented a perfectly coordinated concept for Coherent

LaserSystems for the cleanliness requirements of production, which

sets standards in terms of cost-effectiveness and sustainability in

the cleanroom.“

ENGIE realizes lighthouse project for cleanrooms

The new cleanroom for Coherent LaserSystems will meet the requirements

of the very demanding ISO 6 classification after its planned

completion in December 2025. The ENGIE team of experts

will achieve this by using its own ceiling elements and filter units,

for example. At the same time, the energy concept focuses on sustainability:

ENGIE Deutschland is installing a photovoltaic system

with an output of 230 kilowatt peak on the roof of the building, which

will contribute to a completely electricity-based, renewable supply.

Among other things, it feeds two water-cooled QUANTUM chillers

with Green Heat Recovery from sister company ENGIE Refrigeration

with a total cooling capacity of two megawatts for the cooling supply.

These refrigeration systems with heat recovery make it possible to

cover the entire heat requirement for heating the building using the

heat generated in the refrigeration process - an approach that has

rarely been used in cleanrooms to date. Maximilian Busch emphasizes:

„In the new clean room for Coherent LaserSystems, ENGIE

Deutschland shows how we can combine the highest standards of

functionality and sustainability with the right concept, even in sen-


page 6/36

sitive environments. This makes this project a beacon project with a

model character for follow-up projects throughout the industry and

fulfills our claim at ENGIE to accompany our customers on their way

to climate neutrality in the best possible way.“ ENGIE Deutschland

has more than 30 years of experience in cleanroom technology and

implements projects throughout Germany for demanding industries

ranging from optics and laser technology, pharmaceuticals, biotechnology

and chemicals to plastics and automotive.

High efficiency in a sensitive environment: ENGIE Deutschland

is building a sophisticated and sustainable cleanroom solution for

Coherent LaserSystems at the Lübeck site.

ENGIE Deutschland GmbH

Heßbrühlstraße 51 D 70565 Stuttgart

Telefon: +49 711 7881210 eMail: markus.huber@engie.com

Internet: https://www.engie-deutschland.de/de

The energy content of 40 kilowatt hours, high safety standards and flexible installation

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© Webasto Group

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Webasto SE

D 82131 Stockdorf


page 7/36

Common humidity measurement

problems and how to avoid them

Accurate measurement starts with correct installation

There are many common mistakes made when installing sensors, all

of which can lead to measurement errors. Inaccurate measurement

can lead to excess energy usage, low product quality and process efficiency,

expensive recalls due to non-compliance, and suboptimal

conditions for people in buildings. The tips below will help you get

your installation right first time, improving your measurement accuracy.

When installing internal wall-mounted sensors, always:

1. Select the right installation location

The most important consideration when installing a measurement

sensor to control an occupied space is its location. You want to measure

the conditions that people are experiencing in the room, so it’s

essential you pick a representative location with free airflow and no

nearby heat sources.

Some common errors to avoid:

– Mounting a sensor in an area with restricted airflow, such as behind

a door, equipment, or furniture.

– Mounting a sensor near anything that produces heat, such as a

radiator, heating duct, or above a printer or photocopier.

– Mounting a sensor in direct sunlight – make sure you consider the

sun at all points of the day.

– Mounting a wall-mounted sensor on the ceiling.

– Mounting a sensor in line with an air duct – this can change the

sensor reading faster than the space itself has time to equilibrate,

meaning more frequent adjustments are made to the system.

2. Mount your sensor in the right direction

Wall-mounted sensors have both the sensor and the electronics

in one compact box, so they are designed to be mounted in a

defined direction. Any heat generated in the electronics flows

upwards, so the sensor needs to be below the electronics to ensure

the heat doesn’t affect the measurement. In addition, if the

sensor is mounted sideways, hot air will not be able to escape,

resulting in a higher temperature reading and a lower humidity

reading.

3. Mount multiple sensors side by side

Some wall sensors generate heat, so it’s not recommended to mount

a temperature or humidity sensor above another wall unit. If you do,

the heat can affect the other sensor’s measurements – this can be a

particular issue for gas sensors, which are known to generate more

heat than other sensors. Instead, you should ideally mount sensors

side by side following the manufacturer’s installation recommendations.

If you must mount sensors above each other, the warmer sensor

should be placed well above any other sensors.

4. Consider the airflow in the room

Standard humidity and temperature sensors are designed to work

well in a typical office environment. If you’re putting sensors in a

room with a forced downwards airflow, such as a cleanroom, hot air

from the top of the electronics will flow down onto the sensors and

raise the measured temperature. The solution to this is to use a sensor

that is designed for cleanrooms and similar spaces. In these sensors,

the sensor and the electronics have been set apart. This keeps

the sensors away from any heating, but still allows for sufficient contact

with the environment.

5. Be aware of pressure differences and poor sealing

If there is a pressure difference between the room you’re measuring

and the wall cavities in the building it can lead to inaccurate rea-


page 8/36

dings. Lower pressure in the room can cause cold air to flow directly

into the sensor through the wiring opening in the wall, lowering the

temperature reading significantly. The solution to this is to seal the

cable feedthrough.

6. Avoid errors caused by conduction

Concrete and steel walls can conduct heat, so sensors bolted to the

wall may not accurately indicate the actual air temperature and humidity.

The solution to this is to add a layer of insulation between

the wall and transmitter, or to mount the sensor on an interior wall or

more insulated surface.

Concrete also affects CO2 measurements – if you mount a CO2

sensor on a concrete surface you will get an extremely low CO2 reading

that is not representative of the air in the room. Fixing a plate

below the sensor will usually fix this problem.

7. Avoid errors caused by body heat

This sort of error is usually seen in handheld measurements, where

body heat causes inaccurate readings. If you’re taking handheld

measurements, don’t hold the measurement device too close to your

body and avoid breathing on the sensor.

When installing duct-mounted sensors, always:

1. Ensure internal and external temperatures are balanced

For duct-mounted devices, the most common source of error is the

temperature difference between the air inside and outside the duct,

for example if you are looking to measure the outdoor conditions

from inside an inlet duct. Temperature differences can cause heat

to flow through the duct sensor tube, distorting the temperature and

humidity readings.

These effects will be more pronounced in insulated ducts or those

with low airflow speeds or shorter sensor insertion depths. The

solution is to use a high-quality outdoor sensor or to properly insulate

the sensor.

2. Protect against condensation damage

If there is high humidity in the duct, and a lower temperature outside,

conduction can cool the sensor tube, causing condensation to

form on the sensor.

Condensation can also form inside the duct and run down the

tube to the sensor. If the sensor is angled downwards this can cause

incorrect readings or even corrosion. To minimize the effects and

possible damage caused by condensation, you should mount the

sensor horizontally or, if necessary, slightly tilted upwards. This will

allow any condensation to fall safely away from the sensing element.

3. Don’t mount sensors in a dead leg

As we have seen with internal wall-mounted sensors, it’s important

to mount sensors in a representative location. If you mount a

sensor in a dead-leg duct section, air may not flow past the sensor,

meaning the measurement will not be representative of the conditions

of the main flow. Air lingering around the sensor will change

more slowly than the main flow, so readings will not always be accurate

for current conditions. Always make sure your sensor has

consistent contact with proper airflow, avoiding dead-leg mounting

locations.

4. Consider your options when installing partly inside a process

For sensors that are installed partly inside a process and partly outside,

the difference in temperature can be very large. For example,

when measuring the temperature and relative humidity in a baking

oven through an insulated wall, a metal sensor body with a thermal

leak will lead to the sensor giving a lower temperature and a higher

relative humidity reading than the actual oven conditions. The thermal

leak is flow dependent – in still air the probe will cool more, leading

to a larger error margin. With higher humidity, not only will the

temperature and relative humidity measurements be wrong, you will

also have a condensation problem.

There are two solutions to this issue. The first is to improve the

installation: move the probe deeper into the process and/or insulate

any part of the probe that is external to the process. This minimizes

the temperature difference and allows you to measure relative humidity

accurately. You could also consider if you really need to measure

relative humidity in the first place. Other parameters are available

– some with the advantage of not being temperature dependent, allowing

you to use a heated probe so no condensation can form.

5. Don’t mount sensors too close to a humidifier

Duct humidity sensors are often used for humidification control,

which is achieved using foggers or spray humidifiers. Mounting a

duct sensor too close to a humidifier causes water to collect on the

sensor and build up in the form of condensation, making it impossible

to take accurate measurements.

In the worst cases the sensor will be ruined, but even in less serious

cases it is impossible to accurately control anything using measurements

taken by a sensor that is constantly affected by moisture.

The periodic wetting and drying of the sensor will cause wild swings

in humidity readings, making equipment run constantly and conditions

to be incorrectly maintained. On top of this, sensor drift and

contamination will be accelerated, further compounding the inaccuracies.

To avoid these issues, duct sensors should be mounted a sufficient

distance from humidifiers. This distance will depend on duct

size and flow rates, but as a rule of thumb, five meters is recommended.

When mounting a duct sensor, it’s also a good idea to make an

additional access port downstream of the sensor that can be used

to temporarily install a reference probe to verify and calibrate your

primary sensor. This port can be covered with duct tape when not in

use to avoid leaks.

When installing outdoor sensors, always:

1. Use a solar radiation shield

Solar radiation can easily heat sensors by 2°C (4–5°F). To avoid the

effects of solar radiation, use a sensor with a high-quality radiation

shield that is black under the plates. Wind will reduce heating, so

mount your sensor in a location with free air flow; you should also

keep your radiation shield clean as a dirty shield will heat up more.

Cleaning may be needed more often in urban locations – if the outside

of the shield looks black or dirty, cleaning is already overdue! If

you are wall mounting your sensor, north-facing walls are usually a

better choice as they get less sun exposure.

2. Protect your sensor from rain and heavy weather

Rain, snow, or condensation can all lead to water being on or near

your sensor, causing drift and humidity readings that are too high.


page 9/36

Heavy weather can also cause damage to the sensor. There are several

ways to protect your sensor from the weather:

– Use a sensor designed to work in humid outdoor conditions

– Mount the sensor in a location with good airflow – wind will cause

water to evaporate, ensuring reliable measurements

– For industrial applications, use a heated probe to eliminate the

effects of condensation

3. Mount your sensor away from other sources of heat

The walls of buildings can have high thermal mass and store heat

or cold; they can also get heated by solar radiation. If your sensor is

mounted close to a wall or black roofing without enough offset, it can

make your measurements inaccurate.

To reduce these kinds of heating effects, outdoor measurement

sensors should be mounted in a location where air flow and wind is

unhindered, ideally on a pole completely away from any buildings, or

on the roof. Avoid dark surfaces in direct sunlight and do not mount

sensors under the eaves of a roof. This is because hot air accumulates

under the eaves, causing inaccurate and unreliable measurement

results.

Vaisala Humidity Academy webinar series

In industrial manufacturing, humidity can be both a necessity and a

pollutant, depending on the application. A greater understanding of

humidity can help you control it better, helping you to improve process

efficiency and product quality while saving energy.

In the Vaisala Humidity Academy webinar series, Vaisala experts

share their knowledge of humidity theory and measurement, as well

as on maintaining audit-proof measurement instruments with long

lifecycles. Each bite-sized episode features real-life examples and

calculations to benefit your application, building on the knowledge

gained as the series progresses.

Vaisala GmbH

Rheinwerkallee 2

Telefon: +49 228 249710

Telefax: +49 228 2497111

D 53227 Bonn

eMail: vertrieb@vaisala.com

Internet: http://www.vaisala.de

Closer to the customer

ENGEL announces investment in Queretaro

According to the already known expansion plans in Mexico, ENGEL together with Queretaro Government announced it’s

investment in the region during a meeting at the Mexican Embassy in Vienna (Austria) by the end of April.

Following its company philosophy, “Close to the customer,” European

injection moulding manufacturer ENGEL will expand its footprint

by building a new multi-faceted facility in Queretaro, Mexico.

Strong global partner with local presence

“We have chosen Queretaro, because it is the place to find, develop

and hold talent”, states Stefan Engleder, CEO of the ENGEL Group.

This is especially important for ENGEL as it is the company’s goal to

establish optimal sales, logistics, and production structures for each

of the three major regions: Europe, Asia, and Americas. It is ENGEL‘s

philosophy to build production plants close to the customers. “This

is why ENGEL decided to build another facility in Queretaro”, Engleder

continues.

Seamless customer experience

Gerhard Stangl, CPO ENGEL Group (2nd from right), together with

Mauricio Kuri González (3rd from right), Governor of Queretaro,

and other representatives of the government at the joint investment

announcement in the Mexican Embassy, Vienna. (Photo: ENGEL)

Gerhard Stangl, CPO of the ENGEL Group, joined the investment

announcement at the Mexican Embassy together with Mauricio

Kuri González, Governor of Queretaro and other Government Representatives.

“Our investment will be around 30 million EUR, by

the end of the current fiscal year we plan to double the number of

employees”, Stangl explains. The land ENGEL is going to purchase

is around 70.000 sqm in order to have space for further growth. Customers

in the United States of America, Canada, Mexico, and South

America will all benefit from the capacity and expertise delivered by

this expansion. The new facility in Queretaro also complements the

market presence of the well-established North American subsidiary.

ENGEL AUSTRIA GmbH

A 4311 Schwertberg


page 10/36

Kindeva Drug Delivery and Syntegon install first

Versynta microBatch in North America

– New Versynta microBatch underlines Kindeva’s market-leading injectable CDMO capabilities

– Fully automated, gloveless production cell sets new standards in microBatch filling

– Designed for regulatory compliance, maximum product yields and fast changeovers

Syntegon has sold its newly developed Versynta

microBatch production cell to its first U.S.

customer. Kindeva Drug Delivery will use Versynta

microBatch to further expand its suite of

aseptic fill-finish contract development and

manufacturing (CDMO) capabilities meeting

the latest global pharmaceutical regulations

and trends. Kindeva develops and manufactures

products across a range of routes of administration

including injectable, pulmonary,

nasal, transdermal, and intradermal delivery.

Robotic competence on the smallest scale

“Syntegon’s Versynta microBatch enables

Kindeva to offer significant flexibility to our

customers by rapidly adding clinical development

and small-scale commercial GMP filling

capacity, which complements our large-scale

vial, syringe, and cartridge isolator filling lines.

Syntegon’s technology expertise is unquestionable,

but it is their ability to partner that

has really made this an ideal collaboration for

Kindeva,” said David Stevens, Kindeva Global

Chief Commercial Officer. “Versynta micro-

Batch provides agility, best-in-class automation,

and sterility assurance that meets our

patient safety and regulatory compliance objectives

which we believe sets the standard for CDMOs.”

The fully automated production cell is specifically designed for

very small batches of highly potent and often highly costly drugs, for

instance in the field of cell and gene therapy, where maximum product

yields are key. Versynta microBatch fills between 120 and 500

syringes, cartridges, and vials made of glass or plastic per hour with

virtually no product loss. Fast batch-to-batch changeovers ensure

that efficiency remains high without compromising on flexibility.

The fully automated Versynta microBatch

production cell with gloveless isolator and

integrated air treatment is the ideal solution for

highly potent drugs for small patient groups.

treatment significantly reduces operator

intervention and the risk of contamination.

100 percent in-process control (IPC)

ensures high quality. Five integrated inline

inspection systems provide special safety,

while optional network cameras ensure

continuous monitoring of production in

the isolator via remote access.

“During my 35 years of working in the

pharmaceutical packaging and processing

business, it is rare to experience the partnership

Syntegon and Kindeva enjoy. With

our joint successes, their experience, and

high level of technical capabilities, Kindeva

is a perfect partner for our technologyleading

Versynta microBatch,” said Kerry

Fillmore, Managing Director of Syntegon

Pharma Technology in North America.

Virtual microBatch and RTU

experience at Achema

Versynta microBatch also caters to the

trend towards ready-to-use (RTU) containers,

which are very popular for both

small batches and high-performance lines.

At Achema, visitors can gain insights into

Syntegon’s comprehensive technological

and pharmaceutical expertise in the “RTU Open Space” at the

booth. In addition to virtual presentations of the Versynta portfolio

for small and micro batches, the experts from Syntegon will offer

comprehensive advice on all aspects of RTU containers – from Annex

1 compliance and filling with 100 percent IPC to the use of gloveless

barrier technologies.

Syntegon sold its new Versynta microBatch to

the first U.S. customer: Kindeva Drug Delivery, a

leading global combination product CDMO.

Prepared for regulatory challenges

As Kindeva serves a global client base, compliance with local regulations

of its target markets is paramount. For Europe, this includes the

new EU GMP Annex 1, which is setting new benchmarks in aseptic

fill-finish operations. Syntegon developed Versynta microBatch with

these requirements in mind: the gloveless isolator with integrated air

Syntegon Technology GmbH

Blaufelder Straße 45

D 74654 Crailsheim

Telefon: +49 7951 4020

eMail: packaging-ph@syntegon.com

Internet: http://www.syntegon.com


page 11/36

Germany‘s only metal-free clean room laboratory

for the geosciences opened at TUBAF

TU Bergakademie Freiberg already has a cleanroom laboratory for the field of applied physics - now, a second one is being

added. However, the new cleanroom laboratory at the Institute of Mineralogy has a special feature: it is metal-free. This means

that the furnishings and equipment are made entirely of non-metallic material, with the necessary metal parts encased

in synthetic substances. If thery were exposed to metal in the room, the highly sensitive analyses for dating rocks would be

falsified.

Professor Marion Tichomirowa and her

team are the first to move into the laboratory.

Together with Junior Professor Maximilian

Lau, Professor Johannes Heitmann and

representatives of the university‘s administration

(Ingolf Köhler, Eric Dalke), the mineralogist

opened the new metal-free clean

room laboratory at TUBAF on 16 April 2024.

The researchers can determine the geological

age of rocks very precisely in the metal-free

clean room using what is known as

uranium-lead dating. Prof Marion Tichomirova

heads the university‘s existing isotope

laboratory and was instrumental in initiating

and implementing the construction of the

new metal-free clean room in the Clemens

Winkler Building. „The Freiberg isotope laboratory

at the Institute of Mineralogy is

the only laboratory in Germany to carry out

high-precision dating of rocks. Compared

to other dating methods, we can determine

the age of rocks ten times more accurately

with this method,“ explains Professor Tichomirova.

This makes uranium-lead dating

the most precise „geological clock“ currently

available to researchers.

Important conclusions

for the Earth‘s history

For example, when it comes to determining

the exact sequence of various geological

events that occurred in close succession,

researchers rely on uranium-lead dating.

„Take the extinction of the dinosaurs: it was

long disputed whether a meteorite impact

around 66 million years ago or strong volcanic

activity led to the extinction of the dinosaurs.

The high-precision dating method

was able to show that both events contributed

to the extinction.“

Another example is the formation of ore

in the Ore Mountains. The uranium-lead

dating from the Freiberg isotope laboratory

has already provided new insights into this:

„We were able to show that the neighbouring

large granite bodies of the Westerzgebirge

are not the same age as assumed. On the

contrary, the granites of Aue-Schwarzenberg

formed first (around 323 - 321 million

years ago), after which the Kirchberg granite

intruded around two million years later (321

to 319 million years ago). Another five million

years later (316 to 314 million years ago),

the magma of the Eibenstock granite solidified,“

Prof Marion Tichomirowa explains.

Metal-free cleanroom ensures

less lead and more precise analyses

The new cleanroom laboratory in the Clemens-Winkler

Building is one of the few

metal-free laboratories in the world. As all

metals contain lead, the dating method can

be falsified by „lead contamination“ even

in a non-metal-free cleanroom laboratory:

„The quantities of lead produced by radioactive

decay in the analysed mineral zircon

are extremely small; they are around

50 picograms, or 0.00000000005 grams.

The amount of lead that is added in the laboratory

during the analytical steps should

therefore be at least 50 to 100 times smaller.

Only in a metal-free clean room is it possible

to achieve such low „blank values“ for lead.“

In the new laboratory, the researchers

can now also analyse smaller and younger

zircons and determine the age of these

rocks even more precisely than before. In

the field of geosciences, TU Bergakademie

Freiberg now has a unique clean room

that enables cutting-edge research. There

are only around 10 to 15 other metal-free

clean room laboratories in the world. The

Free State of Saxony is covering the costs

of around 2 million euros for setting up the

laboratory.

Technische Universität Bergakademie Freiberg

D 09599 Freiberg

View of the new metal-free clean room laboratory.

Das Reinraumlabor verfügt über eine automatische

Steuerung der Labortechnik.


page 12/36

Turnkey expert presents new

technologies for filling solutions,

isolators, and freeze dryers

OPTIMA at

ACHEMA 2024

At ACHEMA, the technology leader

from Schwäbisch Hall, Germany will display

its MultiUse filling line. Visitors will see an

integrated filling solution with an isolator.

(Source: Optima)

From June 10-14, 2024 Optima will be at ACHEMA in Frankfurt am Main. At the world‘s leading trade show for the process

industry, the packaging and filling equipment provider will present its complete, integrated turnkey solutions for the pharmaceutical

and biotech industries. Visitors at the booth A73 in hall 3.0 will get an exclusive look at a highly flexible MultiUse

system with isolator, the sterility test isolator STISO, and the new LYO-SCALE freeze dryer for scale-up processes.

Optima has a unique position in the market as an expert in turnkey

systems comprised of filling lines, isolators, and freeze dryers. Its integrated

complete solutions from a single source include filling and

closing of various products, as well as containment and freeze-drying

systems. At ACHEMA, the technology leader from Schwäbisch

Hall, Germany will be exhibiting the MultiUse filling line, the latest

sterility test isolator STISO, and the new LYO-SCALE freeze dryer.

Visitors will gain comprehensive insight into the three components

of a turnkey system.

„With our turnkey approach for filling systems, freeze dryers, and

isolators, we ensure that all components fit together seamlessly and

that our customers benefit from maximum safety,” says Matthias

Poslovski, Vice President Sales at Optima Pharma. „Only when every

component is perfectly matched you can assure safe and smooth

production.”

Visitors can learn more about isolator technology and digitalization in

Optima’s Expert Zone. (Source: Optima)

Live experience on the booth

Flexibility and innovation - this is Optima‘s MultiUse portfolio. From

R&D product and process development to clinical studies and commercial

production, the system portfolio covers all applications and

performance ranges. The MultiUse is flexible and cost-effective and

handles different types of containers including vials, syringes, and

cartridges. As turnkey partner, Optima integrates all process steps,

including isolator and freeze dryer, to provide a complete solution.

The integrated filling solution with isolator will be demonstrated at

booth A73 in hall 3.0.

„Processing of highly sensitive pharmaceutical or biotech products

requires maximum safety. Our holistic turnkey approach of

filling machines with isolators meets the highest requirements,“ explains

Matthias Aster, Director Sales at Optima Pharma.

Isolators are used in a wide variety of applications, with one

thing in common: Providing maximum safety and protection. Optima‘s

sterility test isolator STISO ensures batch sterility through

stable testing and fast, reproducible decontamination. Modularly

adapted to production, it accelerates processes and the path to batch

release. The latest version of the STISO will be on display at Achema.

Visitors will also be able to experience Optima’s new freeze-drying

solution. With the OPTIMA LYO-SCALE, recipe parameters for

lyophilization processes can be developed on a small scale and precisely

scaled-up for larger systems. Optima‘s lyophilization solutions

preserve highly sensitive pharmaceutical or biotech drugs and ensure

maximum shelf life. Integrated into a filling line with isolator, they

provide customers a complete turnkey system.

The Expert Zone offers more displays of isolator technology

and digitalization. Experts will be on hand to discuss turnkey solutions,

bio-decontamination, glove minimization, digitalization, and

Annex 1.

OPTIMA packaging group GmbH

D 74523 Schwäbisch Hall


page 13/36

Researchers from Fraunhofer ITEM, Fraunhofer IWS, and the

University of Regensburg are jointly investigating the growth

of tumor cells in microphysiological systems.

© minkus-images.de/Fraunhofer IWS

Fraunhofer IWS has been developing microphysiological

systems the size of a box of tablets for several years.

Cultivating up to ten tissue slices on one chip is now

possible. © minkus-images.de/Fraunhofer IWS

Fraunhofer IWS Develops Microphysiological Systems for Cultivation

of Tumor Tissue Sections in Joint Effort

New Opportunity for Cancer Therapy:

Miniature Lab Provides Insights

into Metastases Development

Every year, around half a million people in Germany are diagnosed with cancer. Despite the existence of effective treatment

options for many types of cancer, many questions about the development of the disease remain unanswered. Why does a

tumor develop? What factors promote the growth of cancer cells? Why do metastases spread to other organs over time? The

animal models mainly in use to date only represent the actual processes in the human body to a limited extent. The Fraunhofer

Institute for Material and Beam Technology IWS in Dresden has developed special microsystems in collaboration

with the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM in Hanover and the University of Regensburg.

They are now using them to examine tissue sections of tumors under realistic conditions.

Fraunhofer IWS has been successfully developing microphysiological

systems in the size of a tablet box for several years. They can be

used to mimic organ function or disease processes in cell culture,

to study diseases outside the organism, meaning ex vivo, and to test

drugs. “We stack multiple layers of plastic film,” explains Stephan

Behrens, development engineer at Fraunhofer IWS. These are structured

earlier using lasers to create channels and chambers as well as

pumps and valves. They represent different processes of the human

body. A blood-like fluid circulates in the microphysiological systems,

supplying the cells with oxygen and nutrients. A new challenge in an

interdisciplinary project was to investigate the metastasis of tumors

in microphysiological systems.

Prof. Christoph Klein, senior professor of Experimental Medicine

and Therapy Research at the University of Regensburg and division

director of Personalized Tumor Therapy at Fraunhofer ITEM,

approached Fraunhofer IWS with this request. Together with the

University of Erlangen-Nuremberg, the German Research Foundation

had approved a new collaborative research center for the Regensburg

researchers in 2020. It aims to uncover how exactly metastases

colonize the organs.

Tumor and Immune System Interact on a Chip

“To study this, it was important for us to integrate several tumor

tissue sections into our microphysiological system,” says Florian

Schmieder, group leader at Fraunhofer IWS. This was achieved for

the first time in the world in this project. Up to ten tissue sections

can now be cultivated in parallel on one chip. The team at Fraunhofer


page 14/36

In order to find out how cancer cells develop and spread

in the body, the research partners want to simulate the

environmental conditions in the microsystems even more

effectively in the future. © minkus-images.de/Fraunhofer IWS

In addition to cancer, other diseases, such as fibrosis,

can also be examined on tissue sections in microphysiological

systems. Scientists from Fraunhofer IWS and Fraunhofer

ITEM are working on this together within the FIBROPATHS

project. © minkus-images.de/Fraunhofer IWS

IWS additionally realized ports from which they can take samples

for examination at any time. “We can also continuously measure

important parameters such as the CO2 content, pH value, and oxygen

concentration,” he continues. “We use these sensors to directly

measure directly inside the microphysiological system and they can

be reused for further investigations.”

Fraunhofer ITEM experts contributed their knowledge of tissue

slices. They opted for ultra-fine sections of lung tissue, explains Prof.

Armin Braun, Head of Preclinical Pharmacology and Toxicology at

Fraunhofer ITEM. “When operating on a patient with a lung tumor,

not only the tumor itself is removed, but also healthy tissue.” A vibratome

equipped with an oscillating razor blade produces waferthin

slices with a thickness of 350 µm and a diameter of around one

centimeter from these samples. These are still well supplied with nutrients.

When applied to the chip, the tissue slices remain vital and

functional in the microphysiological system for an extended period

of time. “We can, therefore, observe the interaction of the human

immune system with the tumor,” adds Braun. All relevant immune

cells are already present in the section. “This means we are very close

to the real system, much closer than would be possible with animal

models.”

Using Systems to Research Other Diseases

How does cancer develop, and how does it spread in the body? An

important point here is that the metabolism in the tumor differs

from that in normal tissue. “It is important for clinicians to be able

to investigate which conditions in an organ attract metastases,”

explains Florian Schmieder. High oxygen concentrations and pH

values are crucial for this. The researchers at the Fraunhofer IWS

want to adjust these environmental conditions even more effectively

in the microsystems in the future. “So far, for example, we have

been able to change the oxygen content in the entire system,“ he

continues. One challenge now is to enable different oxygen concentrations

on a chip to observe the reaction of the tumor cells and

metastases.

Ideally, combining several types of tissue from one patient

would be feasible. “Such samples prove scarce in reality,” explains

Schmieder. However, combining blood samples and tissue from the

same patient in the system is possible. In combination with the various

sensors, this results in an added value previously not achievable

using other methods. The technology can also serve as a sensible

alternative to previous animal experiments. Unfortunately, research

cannot yet eliminate the need for animal models.

In parallel, the 15-member team at Fraunhofer IWS is currently

working on projects to test the use of tissue slices for other diseases.

One example is fibrosis. In this case, the immune system reacts differently

to the tissue, which then hardens pathologically and partially

loses its function. These processes restrict the function of tissues

and organs. “We are working on this issue in the Fraunhofer internal

project FIBROPATHS,” says Schmieder. The aim is to clarify which

specific systems the individual tissues need in the mini-laboratory

to cultivate them for a longer time period.

New Therapies for Cancer Patients Possible

Prof. Christoph Klein is encouraged by the gained research results

into tumor growth and metastasis formation with the help of microphysiological

systems. “If we want to investigate diseases, this

is an interesting new opportunity for us,” says the physician. “Understanding

metastasis comprehensively is a key to new therapeutic

methods that prevent the subsequent formation of metastases in the

bodies of cancer patients.”

Florian Schmieder sees excellent potential for the future in technology:

“We are becoming increasingly modular with our systems.”

In the future, different components could be combined in new ways

to clarify various scientific issues.

Fraunhofer-Institut für Werkstoff- und Strahltechnik IWS

D 01277 Dresden


page 15/36

Drug discovery for new therapies

Ice-free cryopreservation (vitrification) of adherent cell systems in the

R2U-Tox-Assay multiwell format. © Fraunhofer IBMT, Bernd Müller

Bioreactor research processes and

cryotechnologies improve active

ingredient tests using human cell cultures

Many new drug candidates end up failing because they cause serious side effects in clinical trials even though lab tests

involving cell cultures have been successful. This is a common occurrence if the cells used come from animal tissue, for

example. Specially prepared cell cultures made from human tissue known as human induced pluripotent stem (hiPS) cells

enable greater reliability in testing, thereby also increasing the chances that a drug will be approved. Fraunhofer researchers

have developed innovative solutions for optimized production of cells in bioreactors and unique cryotechnologies. This is

paving the way for efficient real-world use of these cell cultures in toxicity testing.and drug discovery.

Researchers are faced with a dilemma if participants experience serious

side effects during clinical trials to test new active ingredients.

Often, this means development of a promising drug candidate will be

halted, so the drug never reaches the market. One of the root causes

is that drug candidates are typically tested using in vitro cell culture

models based on animal cells or on animals first. In either case, there

are limits to how well the test results translate to human subjects.

That means there is a risk that trial participants will suddenly experience

intolerable side effects.

Medical researchers have high hopes for what are known as

human induced pluripotent stem (hiPS) cells. These cells originate

from human tissue, so they are a much more accurate basis for determining

how substances will work in human subjects than conventional

tests. The cells are taken from human skin tissue or a blood

sample and then undergo a special reprogramming procedure in the

lab. After that, they are no longer programmed for a single type of

tissue, which is why they are called “pluripotent.” For drug testing

purposes, the hiPS cells can then be re-differentiated into almost

any kind of cell found in the human body. This significantly lowers

the risk of undesirable side effects occurring in subsequent human

clinical trials.

Bioreactors for scaled-up cell production

The cells needed for the tests are produced in bioreactors. A team of

researchers headed by Dr. Julia Neubauer, head of the Cryo & Stem

Cell Technologies department at the Fraunhofer Institute for Biomedical

Engineering IBMT, has now made a significant advance in

multiplying and differentiating hiPS cells in a bioreactor. “It is now

possible for the first time to scale up the process so large quantities


page 16/36

Various bioreactor systems for cultivating induced pluripotent stem cells

(iPSCs) on microcarriers. © Fraunhofer IBMT, Bernd Müller

In vitro pharmacological and toxicological screening involving neural

cells. © Fraunhofer IBMT, Bernd Müller

of functional cells are created in a short time,” Neubauer says.

The challenge for the Fraunhofer scientists participating in the

R2U-Tox-Assay joint project was to find out how best to replicate the

environmental conditions naturally occurring in the human body in

a bioreactor so the cells multiply quickly without any loss of functionality.

“We developed and produced our own elastic hydrogel to

act as a substrate specifically for the bioreactor. The cells are right

at home there, so they can proliferate effectively. The chosen parameters

allow us to produce quantities that are relevant for medical

testing of up to several billion cells,” Neubauer explains.

The cell models produced in this way — which can be differentiated

into tissues such as heart muscle, skin, or neurons — can then

be used in assays for testing drug candidates and determining their

toxicity. Another advantage is that the hiPS cells are human cells that

still contain the donor’s genome information, which makes it possible

to develop appropriate tests of new active ingredients to treat

diseases and disorders with a genetic component as well.

Cryotank flash freezing

However, there is another issue for both drug researchers and university

medical centers: storage and availability of cell cultures. The

Fraunhofer researchers put their decades of expertise in cryopreservation

of cells to work on this question.

Fraunhofer IBMT has developed cryopreservation methods

found nowhere else in the world. Liquid nitrogen is used to cool the

cell models grown in the bioreactor from about plus 23 degrees Celsius

down to minus 196 degrees within two seconds. The Fraunhofer

researchers have also developed a special cell culture plate that can

be used to first culture the cells and then freeze them. Combined

with the rapid freezing process, special freezing media impair the

formation of ice crystals in the cell tissue, which would damage the

material and leave it mushy. “If you’ve ever frozen strawberries at

home, you’ll be familiar with this undesired effect,” Neubauer says

with a smile.

She and her team developed a detailed cryopreservation protocol

describing the correct procedure. The protocol sets out parameters,

such as cooling speed and the times the freezing media need

to take effect, for the specific types of cells to be preserved. These

methods ensure that the sensitive human cell cultures will retain

their full functionality after they are removed from cryostorage and

then thawed. The standardized cell culture plates make it possible

to store and transport the cell cultures almost without limitation for

the high-throughput screenings used in pharmaceutical research.

Hospitals and pharmaceutical labs can keep cell cultures in stock so

they always have the right cells available for toxicity and drug testing.

Improved candiate tests for new drugs

The refined bioreactor and cryostorage concepts clear the path forward

for efficient real-world use of hiPS cells in medical research.

Traditional in vitro tests involving animal cells and ethically problematic

animal testing are both replaced by significantly more accurate

testing systems. “On the whole, the accomplishments of R2U-Tox-

Assay enable more efficient, safe development of drug candidates to

treat a range of diseases, including heart and eye diseases and even

neurological disorders such as dementia,” Neubauer says.

Fraunhofer IBMT’s partners in the recently concluded joint project

were Janssen Pharmaceutica N.V. and the Institute for Bioengineering

of Catalonia. The project received funding as an innovation

project under the EU’s major EIT Health initiative.

Fraunhofer-Institut für Biomedizinische Technik IBMT

D 66280 Sulzbach


page 17/36

Next-generation encapsulation technology

FDmiX: Fast, robust series

production of nanoparticles

Nucleic acid-based medications such as mRNA vaccines offer tremendous potential for medicine and are opening up new

therapeutic approaches. These active ingredients must be enclosed inside nanoparticles to ensure that they get to where

they are needed inside the body’s cells. The Fraunhofer Institute for Production Systems and Design Technology IPK and

FDX Fluid Dynamix GmbH have worked together to develop a technology platform for the production of nanoparticles that

can achieve particle quality and stability at levels previously out of reach: FDmiX, short for Fraunhofer Dynamic Mixing

Technologies. Swiss chemical and pharmaceutical company Lonza has now licensed the technology for its own good manufacturing

practice (GMP) production activities.

RNA and DNA, both nucleic acids, are not only found in cells; they

can also be components of medications. One common example

widely known from the coronavirus pandemic is mRNA vaccines.

Medical professionals the world over are very hopeful about nucleic

acid-based active ingredients, which offer potential as therapies for

diseases that were previously difficult to treat, including some forms

of cancer. However, safely and effectively transporting these sensitive

nucleic acids to the cells, where the messages they carry can be

translated into proteins, has proven to be a significant challenge thus

far. A protective envelope is needed to get the sensitive active ingredient

into the cells. These nanoparticles are produced using fluid mixing

processes. Very thorough, rapid mixing is necessary to produce

particles of the requisite quality. Impinging jet mixers (also known as

T-mixers or Y-mixers) are available for industrial-scale applications.

They enable high throughput, but at the expense of mixing quality.

Better, faster mixing

In the Fraunhofer Dynamic Mixing Technologies (FDmiX) platform,

Fraunhofer IPK and FDX Fluid Dynamix GmbH have managed to

bridge the gap between mixing quality and throughput. The FDmiX

platform allows for consistently high mixing quality at any scale, from

the lab right up to mass production. It has already successfully passed

tests aimed at production of lipid and polymer nanoparticles and

of nanoemulsions. As extensive testing has shown, the mixing quality

of the FDmiX technology platform is superior to the systems that

have been available to date, enabling production of particles at previously

unattainable levels of quality. The system is also impressive

in terms of its scaling capability, as encapsulation can take place with

volume streams ranging from 5 ml/min to 1.5 l/min without affecting

the particle properties. Lonza, a global development and production

partner to the pharmaceutical, biotech, and neutraceuticals markets,

has licensed the patented FDmiX technology and is already using it.

“Human cells defend themselves against foreign genetic material.

That’s why the mRNA active ingredients have to be enclosed

inside nanoparticles. So the particles act as a protective envelope,

encapsulating the substance until it has entered the cell inside the

body,” says Christoph Hein, head of the Ultra- and High-precision

Technology division at Fraunhofer IPK in Berlin. To be able to produce

the nanoparticles, the active ingredient dissolved in a buffer

has to be mixed with another solution, such as a lipid solution. Once

the two liquids have been combined, lipid nanoparticles are formed

which in turn form a lipid envelope around the active ingredient.

“With the FDmiX platform, we can produce significantly smaller and

FDmiX M mixer for producing nanoparticles.

© B. Bobusch/FDX Fluid Dynamix GmbH

more homogeneous particles and even adjust their size. FDmiX lets

us produce mixtures of a previously unattainable level of homogeneity

with very short mixing times. That’s relevant because the mixing

quality not only determines the quality of the nanoparticles, but

ultimately also how effective they are.”

Clever nozzle design leads to homogeneously

mixed nanoparticles

But how can a high and consistent mixing quality be combined with

throughput? The centerpiece of the FDmiX platform is an OsciJet

nozzle from FDX Fluid Dynamix GmbH. Inside the nozzle, a jet of

liquid is positioned on one of the sides of the main chamber. Before

leaving the nozzle, a small part of the jet is deflected into a side

channel. At the end of the side channel, it meets the main jet again

and pushes it to the other side. This causes the main jet to oscillate

continuously from one side to the other at a high frequency. In

this way, the jet of lipid solution oscillating through the nozzle meets

the stream of the mRNA active ingredient at a perpendicular angle,

creating a homogeneous mixture with nanoparticles of uniform size.

In tests of conventional impinging mixers (also known as T-mixers

or Y-mixers), by contrast, the lipid solution and mRNA active ingredient

collide before flowing together through the same channel. This

creates a dynamic vortex, resulting in inhomogeneous particles of


page 18/36

lower quality. “In encapsulation tests on mRNA in lipid nanoparticles

using different mixers and flow rates, FDmiX generated smaller

particles with significantly lower size distribution compared to a T-

mixer at the same flow rate,” Hein explains. In tests, the project partners

produced nanoparticles about ten to 20 percent smaller than

those produced using a T-mixer. They also had significantly smaller

size distribution and high encapsulation efficiency and particle integrity.

Large quantities of nanoparticles are needed during the clinical

phase and the subsequent production stage. Here as well, the

technology from Fraunhofer IPK and FDX Fluid Dynamix GmbH is

impressive: The two project partners developed and tested mixers

for various pressure and flow rates. The smallest mixers (FDmiX XS)

can work at flow rates under 5 milliliters per minute, while the largest

(FDmiX XL) can work at more than 1.5 liters per minute.

Broad range of applications for FDmiX nanoparticles

The nanoparticles produced in this way can be used for a wide range

of applications, well beyond encapsulation of mRNA and stabilization

of vaccines. For example, this technology can also be used in

cardiology for cardiac catheter coatings. When a balloon catheter is

expanded during an examination, nanoparticles are absorbed into

the arterial wall, preventing new deposits from forming there. This

can help to prevent stenosis, or narrowing of the blood vessels. Nanoparticles

are also used in tumor therapy, and the molecules may

also be helpful in treating neurodegenerative diseases such as Alzheimer’s

and other forms of dementia.

Das Fraunhofer-Institut für Produktionsanlagen und Konstruktionstechnik IPK

D 10587 Berlin

Polaris is the First Laboratory Glove and Personal Protective Equipment Product

to receive this certification

Kimtech Polaris Nitrile Glove

Earns ACT Label from My Green Lab®

Kimberly-Clark Professional announced today that its recently

launched Kimtech Polaris Nitrile Glove has earned the Accountability,

Consistency, and Transparency (ACT) Environmental Impact

Factor Label from My Green Lab®, a non-profit environmental

organization dedicated to building a global culture of sustainability

in science. The ACT Label is the world’s premier ecolabel for laboratory

products. The program ensures accountability, consistency, and

transparency in the reporting of environmental impact data to enable

sustainable laboratory procurement.

Since 2017, more than 1,100 lab products have received an ACT

Label from My Green Lab. Not only is the Kimtech Polaris Nitrile

Kimtech Polaris Nitrile Glove and its Accountability, Consistency, and

Transparency (ACT) Label keep customers’ sustainability goals at the

forefront of the decision-making process.

Glove the first laboratory glove and personal protective equipment

(PPE) product to earn an ACT Label, but Kimberly-Clark Professional

is also the first PPE supplier to have earned an ACT Label.

“At Kimberly-Clark Professional, we are focused on bringing our

customers value-added innovation in an environmentally friendly

fashion,” said Anuj Sinha, General Manager, Global Scientific. „To

bring more transparency to the market, we chose to go through the

ACT certification process with our Polaris Nitrile Glove to give customers

visibility into our supply chain integrity.“

The criteria for receiving an ACT Label, also known as the Environmental

Impact Factor (EIF) criteria, entails third-party verification

of the environmental impact of a product, its operations, and its

end of life. Completing this process and achieving certification for

a product offers a baseline and framework for continuous improvement

for product manufacturers, while also enabling customers to

make more informed decisions on the products they purchase for

their labs.

In many work environments, it is critical for workers to utilize

single-use PPE products, such as nitrile gloves, to protect themselves

and their processes. Kimtech Polaris Nitrile Gloves’ highquality

nitrile formulation offers not only uncompromised protection,

strength, and comfort, but also keeps customers’ sustainability

goals at the forefront.

Kimberly-Clark Europe

RH2 9QP Reigate Surrey

United Kingdom


page 19/36

Advanced Research Center brings together research on key technologies to accelerate

biopharmaceutical product development.

Merck Invests More Than

€ 300 Million in New Life Science

Research Center in Germany

– German Chancellor O. Scholz emphasizes significance for Germany as research location at cornerstone laying ceremony

– Research center to accelerate biopharmaceutical product development

– Part of Merck’s € 1.5 billion investment program in Darmstadt by 2025

Merck, a leading science and technology company, is investing more

than € 300 million in a new research center at its global headquarters

in Darmstadt, Germany. In the Advanced Research Center, the

Life Science business sector will research solutions for manufacturing

antibodies, mRNA applications and additional products required

for biotechnological production, among other things. As of the

start of 2027, it will provide space for around 550 employees. Today,

Merck laid the cornerstone for the building together with German

Federal Chancellor Olaf Scholz. The new building is part of an investment

program in the Darmstadt site: Merck will invest around €

1.5 billion in total by 2025.

Federal Chancellor Olaf Scholz: “Investments such as those

made by Merck here at its headquarters in Darmstadt make tremendous

economic, medical and scientific sense. They are a tribute to

Germany as a leading pharmaceutical, industrial and research location

and reflect the strength of the life sciences. All of this proves

that we are on the right track with the changes that we have made

with a view to offering the pharmaceutical and biotech industry better

conditions. The German Government will continue to tread this

path with all due resolve.”

“With this strategic investment, we are strengthening the leading

position of Merck in key technologies for the development

and manufacture of novel medicines,” said Belén Garijo, Chair of

the Executive Board and CEO of Merck. “As a leading provider of

life science technologies, we continue to invest in research and development

‘Made in Germany’. In doing so, we are enabling scientific

progress for the benefit of millions of patients and customers

around the world.”

The Advanced Research Center brings together research on key

technologies of the Life Science business sector of Merck. These

include raw materials and processes for researching and manufacturing

antibodies, recombinant proteins and viral vectors. The company

also researches cell culture media and pharmaceutical formulation

and purification aids as well as digital reference materials. In

addition, the scientists are developing analytical chromatography

further. This is a method for separating, identifying and quantifying

chemical substances in a sample. Research along the mRNA value

chain will also be based in the new center.

With the Advanced Research Center, Merck is supporting its

customers in Europe and globally when it comes to finding solutions

for crucial medical challenges. Antibodies and recombinant proteins

are used to treat cancer, autoimmune diseases and infectious

diseases, among other things. Viral vectors are predominantly used

in gene therapies and vaccines while mRNA is currently being researched

mainly for vaccines and cancer treatments. Research on these

therapies is developing rapidly and is constantly opening up new

application possibilities. In the area of mRNA alone, more than 740

clinical trials are currently in progress globally.

With around 18,000 square meters, the Advanced Research

Center enables collaboration across departments in an open, modern

work environment. Merck is planning almost carbon-neutral

research operations. Energy supply is based on photovoltaics, geothermal

energy and air-source heat pumps. The specially designed

facades and the green roofs also help to save energy and improve the

microclimate. The building is striving for gold certification from the

German Sustainable Building Council.

The Darmstadt site is one of the most important Merck centers

for research and development in life science technologies. In the

next ten years, approximately one fifth of the Life Science business

sector’s sales with new products are estimated to come from here.

Since 2020, Merck has announced investments of more than € 2 billion

in the business sector globally. The objective is to expand Life

Science’s capacities and capabilities to meet the globally increasing

demand for medicines.

Merck KGaA

D 64293 Darmstadt


page 20/36

SÜDPACK’s greenhouse gas reduction

targets validated by the SBTi

A key milestone in climate protection – in April 2022, SÜDPACK committed to the targets of the Science Based Targets

initiative (SBTi). At the end of 2023, the company submitted its concrete targets to the SBTi for reducing greenhouse gas

emissions and for improving its carbon footprint. Two years after signing the Commitment Letter, they were successfully

validated in April 2024.

Climate protection requires consistent action based on the latest

findings in cli-mate science. Which is why in its 2030 Sustainability

Strategy, the film manufac-turer SÜDPACK consolidated an extensive

series of measures and initiatives in the NET ZERO central area

of action, which aims to reduce harmful emissions in ac-cordance

with the Science Based Targets initiative (SBTi). The SBTi is a joint

initia-tive of CDP, UNGC, WRI and WWF, and has indicated that,

like SÜDPACK, more than 5,000 companies worldwide have already

anchored effective climate protec-tion at a corporate level and have

defined SBTi targets to be able to limit global warming to 1.5°C.

The path to greater sustainability

The submission of the climate targets was preceded at SÜDPACK by

a comprehen-sive analysis of the Corporate Carbon Footprint (CCF)

of all production sites and sales offices. The emissions for 2021 and

2022 were recorded and evaluated, and 2021 was set as the base year

for measuring progress.

The scope 1 and scope 2 emissions according to the Greenhouse

Gas Protocol Standard are always taken into account. They cover the

direct activities of the company as well as its energy requirements.

In addition, SÜDPACK includes part of the scope 3 emissions since

these account for approximately 90% of the total emissions for the

manufacturer of high-performance films, particularly in the field of

purchased goods and end-of-life disposal.

Within the scope of its NET ZERO aim, SÜDPACK has specifically

committed itself to reducing its greenhouse gas emissions by

76% in scope 1 & 2 by 2030. For indi-rect emissions, a reduction target

of 25% has been set for scope 3 in the “pur-chased goods and

services” category. Building on these targets, SÜDPACK is cur-rently

developing its CO2e reduction projects, which will be rolled out for

the en-tire company.

Concrete projects for target achievement

When it comes to renewable energy, SÜDPACK is already on the

home stretch. For example, all German production sites operate

using 100% green electricity, part of which is produced by the company’s

own PV systems. Rapid progress is also being made in transitioning

the product portfolio to sustainable solutions. The focus

is primarily on reducing material use and on developing recyclable

monomaterials. In the future, special attention will also be paid to

emissions when goods are pur-chased, for example by using granules

made from renewable raw materials.

“To evaluate the environmental impact of a film or packaging

concept over its entire life cycle, we developed an LCA tool in 2023

that also takes account of re-cycling options after the use phase,” added

Valeska Haux, Vice President Strategic Marketing & Sustainability

at SÜDPACK. In the context of a holistic approach, SÜDPACK is

also concentrating on mechanical and chemical recycling in order to

recycle existing plastics. “Innovation for a better future” is the maxim.

“Our com-mitment to mechanical material management as well

as the future-oriented recy-cling technology from Carboliq is, in our

view, more than just an effective contri-bution to CO2 reduction. It

is also an important impetus for a circular economy in the plastics

and packaging industry as well as an essential building block in this

necessary process of transformation,” highlighted Haux.

SÜDPACK VERPACKUNGEN SE & Co. KG

D 88416 Ochsenhausen


page 21/36

With a speedy data connection that Single Pair Ethernet realizes, new

ways of operating a process and maintaining a facility become possible –

with the target of increasing process reliability and plant availability.

Single Pair Ethernet allows a bandwidth and speed that lifts

field data transmission to a completely new level. Maintenance

and plant managers benefit from new insights.

Joining forces with the SPE alliance means committing to customer benefits

Single Pair Ethernet:

Endress+Hauser teams up

for the future of automation

Endress+Hauser, a global leader in measurement instrumentation, services and solutions for industrial process engineering,

is proud to announce its partnership with the Single Pair Ethernet System Alliance. This strategic alliance underscores

the company’s commitment to simplifying our customers’ digitalization needs and investing in the future of automation.

What is the role of Single Pair Ethernet (SPE) in automation?

SPE is a game-changer, especially for the food & beverage and life

sciences industries. In highly automated process environments without

extensive hazardous protection, SPE delivers a variety of benefits:

it realizes the advantages of an Ethernet connection – such as

the high speed and volume of transmitted data – at field level with

a simple two-wire cable, which transmits both data and energy. The

commissioning process is simplified with easy wiring and connectivity.

Moreover, the automation pyramid is flattened as other systems

can now connect via Ethernet at field level, fostering seamless integration

and interoperability. Data from smart instruments in the field

can be processed in upper layer applications. This results in optimized

machine design, connectedness and improved overall equipment

effectiveness (OEE). For this reason, SPE proves its worth as

an open, cost-efficient and future-proof technology that is ready for

the Industrial Internet of Things (IIoT).

Joining forces increases customer value

Endress+Hauser is dedicated to easing the digitalization journey for

its customers. By joining the Single Pair Ethernet System Alliance,

the company is demonstrating its trust in the members that are

committed to shaping the future of automation together. Customers

benefit from interoperability by driving business with the members

of the SPE System Alliance. Close to 75 members are creating the

largest ecosystem of SPE products, creating freedom of choice for

customers. Endress+Hauser’s entrance into the partnership opens

the door for sharing knowledge and expertise to deliver superior solutions.

Prospective product portfolio

To offer customers the chance to grow their digitalization capabilities

and realize all the benefits of SPE, Endress+Hauser is now

working on its portfolio of field devices with SPE. A clear goal is to

create a harmonized approach, comparable to the manufacturer’s

Ethernet-APL devices. The comparison with Ethernet-APL – another

industrial Ethernet technology – shows that a uniform connectivity

and certification concept is essential, whether for hazardous or

non-hazardous areas. This gives customers across diverse industries

more flexibility to profit from the benefits of a well-functioning data

highway. zierungskonzept unerlässlich ist, egal ob im nicht explosionsgefährdeten

oder im explosionsgefährdeten Bereich. So können

Kunden aus unterschiedlichen Branchen flexibel von den Vorteilen

einer leistungsfähigen Datenautobahn profitieren.

Endress+Hauser AG

CH 4153 Reinach BL 1


page 22/36

Until now, simulation results were only measurable – soon, they are also countable.

SIGMAecon enables process-dependent cost calculation, thereby providing the

opportunity to determine the best compromise between quality, optimal process,

and minimal cost

Process simulation enhanced

by realistic cost calculation

With the new version SIGMASOFT® 6.1, SIGMA Engineering

GmbH releases SIGMAecon among other features. This tool offers

the possibility of cost estimation directly combined with simulation

results. Thus, the best compromise between quality, process,

and costs can be quickly identified, as quality, productivity, and resources

are simultaneously considered.

For more than 25 years, professionals have been calculating every

detail in the molding process of polymers accurately and reliably

with SIGMASOFT® Virtual Molding. In addition to physical results

such as pressure, temperature, or time, the new tool SIGMAecon

now adds financially quantifiable results.

The detailed knowledge of own production processes and their

optimization possibilities is crucial in the increasingly competitive

environment. Often even more important is knowing the real manufacturing

costs. For instance, is an (assumed) optimization associated

with lower costs due to reduced cycle time? Or do costs increase

due to higher energy consumption?

Securing a contract often depends on offering an aggressive selling

price. However, turning such a project into a sustainable success

requires precise knowledge of one‘s own costs beforehand. During

the inquiry phase, SIGMASOFT® allows for quick examination and

optimization of several important scenarios. Accurate predictions

regarding time, material or pressure requirements, flow diagrams,

etc., can then be provided to the pricing calculation as well-founded

references.

However, SIGMAecon takes it a step further by allowing the user

to precisely determine the component costs of the currently simulated

process and its optimization variants. Modified thermal concepts

(such as the use of hot or cold runner technology or additional

insulation) are not only considered as additional costs or material

savings but also in terms of the energy consumption.

„The benefits for our users are clear,“ says Thomas Klein, CEO

of SIGMA. „With SIGMASOFT® Virtual Molding, process optimizations

are already possible during the inquiry phase. SIGMAecon

assists in decision-making in engineering and strengthens the user

as a central source of reliable information, from both technical and

financial perspectives.“

SIGMAecon includes predefined templates as well as the ability

to define all inputs freely. The results are presented in tables or

diagrams but can also be evaluated directly from a Design of Experiments

(DoE) with SIGMASOFT® for comparing different scenarios.

This enables the optimization of manufacturing costs, which are

now known in detail at the earliest possible stage.

SIGMA Engineering GmbH

D 52072 Aachen


page 23/36

Swiss Biotech Report 2024 shows

sector performing well in 2023 by continuing

to embrace international alliances

– Record revenues of CHF 7.3 billion (USD 8.1 billion)

– Capital investments increase by more than 50% to CHF 2 billion – CHF 1.4 billion by public companies,

CHF 0.6 billion by private companies

– Significant licensing and M&A activity in 2023 – VectivBio, T3, Vertex, Santhera

– R&D investments of publicly traded biotech companies have decreased in line with global markets, whereas

privately financed companies were able to increase both R&D investments and liquidity reserves

– Record number of product approvals by Swissmedic, EMA and FDA – including world’s first CRISPR

gene editing therapy

– Swiss Biotech Day increases international presence with full launch of Global Village, the partnering platform

for international delegations

During 2023, Switzerland’s biotech sector

again demonstrated considerable agility

particularly in commercialization and financing

activities to continue to play a key

role in driving global healthcare innovation.

In addition to record revenues of CHF 7.3

billion, the industry raised more than CHF

2 billion – a remarkable 50% increase over

2022. This comprised around CHF 1.4 billion

collected by public companies, and the

remaining CHF 0.6 billion by private companies.

Although R&D investments dipped

slightly to CHF 2.4 billion, they are still at

very high levels. The latest edition of the

Swiss Biotech Report launched today by the

Swiss Biotech Association, in conjunction

with EY and eight other partner organizations,

provides an analysis of the 2023 biotech

funding as well as other 2023 key ratios and

statistics. The 2024 Swiss Biotech Report’s

theme of ‘Reliable Partners Beyond Borders’

focuses on the positive impact of Swiss

collaborations at all levels of the global life

sciences ecosystem – from research & development

to manufacturing and regulatory

harmonization.

Michael Altorfer, CEO, Swiss Biotech

Association, commented: «The World Intellectual

Property Organization, WIPO,

has placed Switzerland top of the Global

Innovation Index for the past 13 consecutive

years. The Swiss Biotech Report shows that

Swiss biotech companies continue to harness

this innovation power to develop effective

new products and solutions that address

global needs. Around 1.5 billion Swiss

francs were dedicated to collaborations all

over the world.»

Swiss Biotech Industry infograph figures 2024

Frederik Schmachtenberg, EY Partner and

Global Life Sciences Lead for Financial Accounting

Advisory Services, added «Swiss

biotech companies attracted more than 2

billion Swiss francs, a more than 50% increase

compared to 2022. While public

biotech companies seemed to have been

at least partially impacted by a dire global

market sentiment, privately financed companies

have raised a solid CHF 0.6 billion,

which even allowed them to increase their

overall liquidity reserves, despite record investments

in R&D projects.»

Key Findings in the

2024 Swiss Biotech Report

Once again, the Swiss biotech industry generated

record revenues of CHF 7.3 billion

compared to CHF 6.8 billion in 2022. This

was driven by significant collaboration and

licensing deals, where Swiss biotech companies

often successfully partner with large

pharma companies, and product sales boosted

by a record number of approvals from

Swissmedic, EMA, FDA and other global regulatory

authorities, including breakthrough

advanced therapies from CRISPR Therapeutics,

Santhera Pharmaceuticals, Idorsia,

Relief Therapeutics and Basilea.

In a challenging global public market,

the main fundraises were achieved by Oculis

SA, with a SPAC transaction on NASDAQ

and follow-on financing collecting USD 144

million and MoonLake Immunotherapeutics,

with CHF 415 million through a followon

transaction from 2022’s IPO. While the

public market sentiment remained dire ever

since the end of the Covid pandemic, the

private funding environment held up well


page 24/36

in 2023. Noema Pharma with CHF 103 million

raised, Alentis Therapeutics with CHF

94 million, Rejuveron with CHF 67 million,

Nouscom with CHF 65 million, and New-

Biologix with CHF 45 million led the way.

2023 also saw significant M&A activity

at all levels from early stage to established

companies demonstrating the maturity of

the Swiss biotech sector. Particularly worth

noting are Pierre Fabre Laboratories purchase

of Vertical Bio, Ironwood Pharma’s

takeover of VectivBio for USD 1 billion and

Boehringer Ingelheim’s acquisition of T3

Pharma for an amount of up to CHF 450

million.

The number of FTEs working in Swiss

R&D biotech companies remained with

over 19,000 people almost unchanged in

2023 compared to 2022. Despite an overall

slight decrease in R&D expenses, the private

companies’ share continued to grow.

Finally, following the creation of an innovation

office in 2022, Swissmedic again

looked to foster international collaboration

and harmonization by establishing ‘The

Access Consortium’ with like-minded medium-sized

regulatory authorities, including

Australia’s Therapeutic Goods Administration

(TGA), Health Canada (HC), Singapore’s

Health Sciences Authority (HSA), and

the UK’s Medicines and Healthcare Products

Regulatory Agency (MHRA).

Expanding the Global Village and

Swiss Biotech Success Stories Awards

for outstanding achievements

The Swiss Biotech Report 2024 was launched

at the Swiss Biotech Day which is

attracting increasing numbers of international

delegates. One contributing factor is

the Global Village, a platform hosted by the

Swiss Biotech Association in partnership

Switzerland Global Enterprise to stimulate

sustainable worldwide networking and international

collaboration in biotech and life

sciences. In only its second year, the Global

Village has already grown by 70% and featured

17 international delegations.

To recognize outstanding achievements,

the Swiss Biotech Association was also presenting

the Swiss Biotech Success Stories

Awards at this year’s Swiss Biotech Day to

the winners Fondation Suisse de Recherche

sur les Maladies Musculaires (FSRMM) and

Dr. Hans-Peter Strebel.

FSRMM was founded in 1985 by Jacques

and Monique Rognon together with two

existing patient organizations to promote

research on neuromuscular diseases. Since

its inception, FSRMM has raised in excess

of CHF 30 million and funded more than

200 research projects at Swiss universities

and hospitals.

Dr. Hans-Peter Strebel founded Fumapharm

AG with three other scientists

in 1983. This was the start of more than 40

years of successful research leading to the

development of Tecfidera, a disease modifying

therapy for relapsing multiple sclerosis

which has so far benefitted more than

600,000 patients worldwide.

Swiss Biotech Association

CH 8004 Zürich

Focus Money magazine names

GEMÜ a „Digital Champion 2024“

Ingelfingen-based technology company GEMÜ has been named a „Digital Champion“ by Focus Money and Deutschland

Test for the third time running. GEMÜ was awarded a ranking of second place among companies recognized in the „machinery

and plant construction“ sector.

Digitalization is progressing at rapid pace, meaning that companies have to seize the opportunities

afforded by digitalization in order to remain competitive and able to act, and

to be among the winners of their sector. In order to identify these businesses, the study by

the IMWF (a German management and economic research institute) thoroughly analyzed

12,300 companies in the categories of digitalization, technology and innovation.

The IMWF collected the findings of the study using the established „two pillars“ test procedure.

The first pillar is based on the social listening methodology. For the social listening

element, approximately 1.5 million entries on the companies being researched were found

online and analyzed with the help of artificial intelligence (AI). The second pillar involves

carrying out surveys within companies using questionnaires. The businesses were asked about

their digitalization measures in different thematic blocks. The findings were evaluated

using a points system, which then determined the „Digital Champions 2024“.

In the „machinery and plant construction“ sector, valve specialist GEMÜ achieved a rating

of 98.3 out of 100 possible points and came second among the companies recognized

in this category.

„Digitalization is and will continue to be the driving force behind companies which want

to keep setting trends in the future. I‘m certain that our global digitalization measures will

help the GEMÜ Group to further expand its position as a technological pioneer in the long

term,“ comments Gert Müller, Managing Partner of the GEMÜ Group on being named a Digital

Champion 2024.

GEMÜ Gebr. Müller Apparatebau GmbH & Co. KG

D 74653 Ingelfingen


page 25/36

The many applications

of cleanrooms:

From medical cannabis

to space pharmaceuticals

Be it cannabis cultivation, pharmaceuticals production or laboratories in space

– cleanrooms protect all manner of applications against two hazards: particulate

and microbiological contamination. Cleanrooms are the only way to ensure the

quality of numerous products and research projects. Cleanroom technology creates

the conditions needed for innovation in a wide range of fields.

Medical cannabis – another

beneficiary of cleanrooms

ce in the chemists and pharmacies of the

Americas and Europe [1]. However, no one

really understood what it contained, how it

worked, or what the best way to cultivate it

was.

Medical cannabis offers an excellent

example of why the best way to cultivate

cannabis today is in a cleanroom. It goes

without saying that cannabis is subject to

the same requirements as are all other medications:

the amount of active ingredient

must be controlled and painstakingly documented

so that the dosage can be precisely

calibrated. Various rules and regulations

must be observed here, in particular the monograph

for cannabis flowers in the German

Pharmacopoeia (DAB), Good Manufacturing

Practice (GMP), and Good Agricultural

and Collection Practice (GACP).

One of the objectives of these regulations

is to prevent contamination with pests,

Visual inspection in the greenhouse and chemical analysis in the laboratory ensure

the quality of medical cannabis. - Photo: Shutterstock

The partial legalisation of cannabis took effect

in Germany on April 1, 2024 – making

this a good opportunity to take a closer look

at medical cannabis. This has been a therapeutic

option for patients in Germany ever

since its medical use was first allowed seven

years ago. For certified cultivation, however,

cleanrooms are required.

The many properties of cannabis have

been appreciated since ancient times, with

a history stretching back to the Egyptians,

Greeks and Romans. In the twelfth century it

found its way into the writings of Hildegard

von Bingen, where it was recommended for

use against various ailments, including pain,

nausea and rheumatism. Cannabis enjoyed

particular success in the 19th century, when

it became the most commonly sold substanmould

spores or heavy metals throughout

the cultivation process – from the cell culture

until the plants bloom. According to

GMP, this requires a special form of documentation

that includes tests for various

heavy metals, determination of the total

bacteria count of aerobic micro-organisms,

additional qualitative (and in some cases

quantitative) proofs of specific micro-organisms,

and the determination of the total

bacteria count of yeasts and moulds. The

control measures extend beyond the cultivation

phase to encompass subsequent processing

(e.g. drying processes).

These strict tests give rise to very particular

requirements for climate control technology.

In order to ensure that the active

ingredient content remains constant, it is

necessary to strictly control a whole range of

factors – especially temperature, humidity,

light, fresh air supply and airflow. This offers

an additional advantage for cannabis growers,

as it also maximises the yield. Even the

water used to irrigate the plants is specially

cleansed and filtered.

Standard-compliant components

ensure quality

Many of these conditions are also characteristic

of cleanroom technology, so it should

be no surprise that satisfying the full range

of regulations is best accomplished by working

under cleanroom conditions, from the

cultivation of the plants through to their

packaging. That is why cleanrooms are an

ideal location for the cultivation of “cannabis

fields”, with the use of special environmental

chambers that can be controlled through

a platform using certified software, including

the recording and archiving of data.

An example is helpful here to illustrate the

scale: two years ago, a cannabis producer in

Switzerland commissioned a 1,100-squaremetre

production facility for the cultivation

and processing of plants under controlled

cleanroom conditions. This is equivalent to

one-seventh of a football pitch.

The entire production process is subject

to strict regulations. Everything must

take place in accordance with GMP and/or

the cleanroom standard DIN EN ISO-14644

(usually GMP D/ISO 9) and in compliance

with the applicable VDI 2083 guidelines

issued by the Association of German Engineers

(VDI). That is why it is advantageous

when building a cleanroom to make use of

components that have already been certified

according to the standards and other applicable

guidelines (e.g. entire environmental

chambers, software, microwave extractors).

The reward for these efforts lies in standardised

tetrahydrocannabinol preparations


page 26/36

suitable for pharmaceutical use. It is also

possible to obtain cannabidiol (CBD) preparations

in this way. Among this substance‘s

properties are an ability to aid sleep, relieve

anxiety and reduce inflammation – and

it does not have any intoxicating effects. As

a result, it can also be found in nutritional

supplements and cosmetic oils.

Space pharmaceuticals are

a focus of research

Cleanrooms are also playing an increasingly

important role in many other production

and research applications – including space

medicine and pharmaceuticals. Pharmaceutical

substances, nutritional supplements

and cosmetics can often be developed more

quickly in weightless environments – in

space, in other words. Zero-gravity increases

the virulence of bacteria, and biological processes

are generally accelerated. The result:

experiments can be accelerated and vaccines

developed more quickly.

Space medicine is also benefiting osteoporosis

medications, because astronauts experience

faster bone loss during their missions

to space. This, too, is leading to more

rapid innovation.

Even the field of agriculture can benefit

from experiments conducted in zero-gravity,

as these have the potential to increase

our understanding of fundamental growth

processes. This can lead to the development

of improved plant strains with higher yields,

increased resistance to pests and diseases,

and many other desirable properties (possibly

even for cannabis!).

Visitors to the cleanroom trade fair Cleanzone

on 25 and 26 September 2024 in Frankfurt

am Main will find out first hand about

the opportunities being created by the latest

developments and pioneering products in

the industry.

cleanzone

Messe Frankfurt Exhibition GmbH

Ludwig-Erhard-Anlage 1

D 60327 Frankfurt am Main

Telefon: +49 69 75756290

Telefax: +49 69 757596290

eMail: anja.diete@messefrankfurt.com

Internet: https://cleanzone.messefrankfurt.com

Literature

1. Barbara Segger: Harmloses Hanfprodukt? (Harmless hemp product?) PTA heute 23 (2023): 88-90

2. https://swisscanntec.ch/marihuana-anbau-produktion, retrieved 28 April 2024

Advisory board confirms

Markus Rustler as interpack President

At the constituent meeting of the Advisory Board of interpack, the world‘s leading trade fair for processing & packaging, the

Chairman and his two deputies were confirmed in their positions. The Advisory Board thus sends a clear signal of continuity

and emphasises the importance of interpack‘s close ties with the packaging industry.

Effectively representing the interests of the industry and acting as a

driving force for innovation and growth - that is the aim of interpack.

The next edition will take place from 7 to 13 May 2026. On the way

there, it will be actively supported by a 21-member trade fair advisory

board made up of leading personalities from the packaging sector

and the related process industry on the manufacturer and association

side.

Markus Rustler, President and CEO of Theegarten-Pactec

GmbH & Co. KG, was re-elected President and thus Chairman of the

Board at the constituent meeting on 9 April 2024. Christian Traumann,

Managing Director of the MULTIVAC Group and Roland

Straßburger, CEO of SCHÜTZ GmbH & Co. KGaA were confirmed

as Vice Presidents. All candidates were elected unanimously.

„I would like to thank you for the trust you have placed in me

and look forward to continuing this task. Our common goal is to build

on the success of interpack 2023 and to further strengthen the

2026 trade fair as a trend, technology and solution platform in order

to proactively meet the opportunities presented by dynamic market

changes,“ said Markus Rustler after his re-election.

„The personal dialogue with our partners from the companies

and associations is of enormous value to us - especially in times of

great challenges. We are very pleased about the extraordinary expertise

and the trusting cooperation in our Advisory Board,“ said interpack

Director Thomas Dohse at the end of the meeting.

The first meeting of the trade fair advisory board marks the start

of the concrete content preparation phase for the next edition of

interpack in May 2026. The world‘s most important suppliers of packaging

machinery and processing technology, packaging materials

and packaging aids, packaging production, finishing and packaging

printing, marking and labelling technology as well as storage, logistics

and transport technology are once again expected to exhibit.

The main themes of the upcoming leading trade fair will be determined

in the coming months.

The supplier trade fair „components“ will once again be organised

parallel to interpack at a central location in the exhibition centre.

Messe Düsseldorf GmbH

D 40001 Düsseldorf


page 27/36

ASM 340 from Pfeiffer Vacuum

OmniStar from Pfeiffer Vacuum

Pfeiffer Vacuum Introduced its Vacuum

and Leak Detection Solutions for the Hydrogen

Industry at Hydrogen + Fuel Cells EUROPE

– Mass spectrometer for gas and residual gas analysis

– Universal leak detector

– Mobile Leak Test Module

amu, 1 to 200 amu and 1 to 300 amu. This makes the OmniStar GSD

350 the fitting solution for material characterization tasks, such as

hydrogen permeation testing through tank materials or sealing materials.

Universal leak detector

Hydrogen + Fuel Cells EUROPE/Hannover Messe. Pfeiffer Vacuum

introduced state-of-the-art vacuum and leak detection solutions for

the hydrogen and fuel cell sector at this year’s Hannover Messe.

State-of-the art mass spectrometer for gas and residual

gas analysis

OmniStar GSD 350 is a compact, portable benchtop device which

permits gas analysis at atmospheric pressure. It enables fast, reliable

and precise measurement of noncondensable gases. The proven

mass spectrometer software PV MassSpec provides qualitative and

quantitative analyses. The systems cover the mass ranges 1 to 100

The ASM 340 is a versatile leak detector for hydrogen and helium.

The ASM 340 can be used not only for qualitative localization of

leaks but also for quantitative integral or local testing. Its powerful

vacuum system sets it apart and guarantees extremely fast operational

readiness. It also features a rapid response time due to its high

helium pumping speed. These characteristics result in short cycle

times and a high throughput rate. The ASM 340 is the only leak detector

in its class capable of locating leaks at pressures below 100

mbar. Leakage testing of fuel cell stacks, hydrogen tanks and integrated

hydrogen circuits are a main focus.

Mobile Leak Test Module

Pfeiffer Vacuum also presented a mobile Leak Test Module which

offers a modular solution for leakage testing. With its individually

configurable components, the module is suitable for a wide range

of leak testing tasks using helium and hydrogen/forming gas as tracer

gases. Its many components permit a wide range of leak testing

with tracer gases and make it individually configurable. Its optional

automation capabilities make it the ideal solution for efficient and

reliable leak testing at the preliminary development stage right up to

the small series level.

And that’s not all – Pfeiffer Vacuum also offers a special Leak

Test Module for monopolar and bipolar plates. It can be fully integrated

into existing production lines. With its multi-patented setup and

process, the module results in short cycle times of under 40 seconds,

thus supporting efficient production.

Leak test module for leak testing monopolar or bipolar plates from Pfeiffer

Vacuum.

Pfeiffer Vacuum GmbH

D 35614 Asslar


page 28/36

ACHEMA 2024 will be more

international than ever

Just over a month before ACHEMA 2024

opens on 10 June, one thing is already clear:

with more than 60 percent of exhibitors coming

from abroad, this year‘s leading trade

show for the global process industry will be

the most international ACHEMA ever. Numerous

side events from renowned partners

await participants from 130 countries.

From 10 to 14 June 2024, 2,800 exhibitors

from more than 50 nations will showcase

their product innovations for the global

process industry at the Frankfurt exhibition

grounds. “The high level of participation

by exhibitors from abroad shows that

ACHEMA continues to gain ever greater

international importance. Compared to the

previous event, more than a quarter more

exhibitors have registered and the exhibition

space is again almost a third larger than

last time. We are fully booked in large parts“,

says Dr Björn Mathes, CEO of DECHEMA

Ausstellungs-GmbH.

The lecture programme, which has been

fully integrated into the exhibition since

ACHEMA 2022, is also reporting record

numbers: In up to 25 parallel tracks, over 900

lectures, discussions and workshops from

more than 1,000 speakers await ACHEMA

visitors. „ACHEMA offers the perfect platform

to showcase and exchange on the latest

innovations, solutions and future trends

across the pharmaceutical and chemical

industry while directly engaging with those

who can benefit from our sustainabilityoriented

solutions,“ says Norbert Strieder,

Head of Marketing Chemical Technologies

at GEA.

Six Innovation Stages on the topics of

Process, Pharma, Green, Lab, Digital and

Hydrogen will focus on the key challenges

facing the process industry today and in

the coming years. In addition to solutions

for a sustainable transformation, ACHEMA

2024 will focus on innovations in the fields

of pharmaceuticals and biotechnology: “Our

innovation map ranges from integrated engineering

and complex production simulations

to sustainable production concepts.

The Pharma Innovation Stage is the perfect

platform to share our innovations with the

global process industry and accelerate technical

progress”, says Andreas Marchler, Managing

Director of ZETA.

Numerous side events from renowned

partners

ACHEMA 2024 will also feature numerous

side events from renowned partners:

In hall 11.0, ARC Advisory Group, NAMUR

and ZVEI are once again organizing a joint

forum at ACHEMA under the name “Automation

in Dialogue”. On all five days of the

exhibition there will be varied lectures and

discussions on the important topics of automation

technology in the process industry.

This year, the final of the AIRA Robotics

Challenge will once again be part of

ACHEMA. In hall 11.1, the five finalist teams

will demonstrate live at ACHEMA how they

remotely control their robots to perform

their tasks in mock scenarios of a chemical

plant or laboratory. The focus this time shifts

to teleoperation, i. e. the use of systems that

enable remote control.

As part of an industry initiative around

the Flow Chemistry Pavilion, a number of

market players are organising the Flow Chemistry

Symposium on 12 and 13 June, where

participants will immerse themselves in

the field of Flow Chemistry under the guidance

of renowned scientists and industry

experts. Sessions will feature compelling

case studies and best practices focusing on

the breakthrough capabilities of continuous

manufacturing technology.

On all five days of the exhibition, the

North American Scientific Equipment and

Furniture Association (SEFA) will welcome

visitors to its SEFA Theatre in Hall 12.0, where

it will provide insights into global laboratory

design. Other topics include sustainability

in the laboratory and the digitalisation

of laboratory infrastructure.

Also at ACHEMA, DEXPI is organising

the Process Industry Data Model Integration

Congress 3.0 (PIDMIC 3.0) on 11 and

12 June. This will address the latest developments

in data integration and focus on practical

applications, standardisation efforts

and technological breakthroughs.

Other highlights of ACHEMA’s side

events include the ISSA symposium on hazardous

substances in maintenance work,

the ELRIG drug discovery forum, the VCW

event on strategies for a sustainable green

chemical industry, the VDI information

platform for engineers in production and

the India Day, which is dedicated to one of

the most dynamic and promising markets at

the moment.

“In addition to all these programme

highlights, which are all included in the ticket,

ACHEMA offers endless networking

opportunities and is therefore more than

just a trade show. It is a platform for technology

and change, where ideas are born

and partnerships are forged,” emphasizes

Mathes. “ACHEMA 2024 will inspire, inform

and encourage on the road to climate

neutrality.”

DECHEMA Ausstellungs-GmbH

D 60486 Frankfurt am Main


page 29/36

Arburg at Chinaplas 2024

Additive manufacturing:

Industrial 3D printing with the Freeformer

– Multi-material: Freeformer exhibit produces gripper in hard/soft combination

– In demand: Additive components made from high-temperature plastics and in multi-material combinations

– Versatile: Processing a wide range of original plastic granulates

Arburg‘s enormous expertise in plastics processing also includes solutions for industrial 3D printing from sister company

ARBURGadditive. The additive manufacturing of grippers and operating equipment, for example, is an interesting option

for injection moulding plants. On the Arburg stand, a Freeformer 300-3X will be producing a gripper in a multi-material

combination at Chinaplas 2024.

Arburg Plastic Freeforming (APF) can also reliably and reproducibly

process a wide range of original and certified plastic granules, including

granules for high-temperature applications. This makes the

process particularly suitable for components used in areas such as

medical technology and aerospace.

Additive manufacturing of end-of-arm tooling (EOAT)

At Chinaplas 2024, a Freeformer 300-3X will demonstrate how

additive end-of-arm tooling (EOAT) for various robotic systems

and handling tasks can be 3D printed on demand quickly,

cost-effectively and customised for specific applications. One

example is a multi-material gripper, which is created in a single

step with the aid of support material and without the need for

any additional assembly work. The result is a resilient functional

component in hard/soft combination. The hard housing is made

of PC/ABS, while the soft TPE nozzle closure expands positively

using compressed air to reliably remove a moulded part from the

mould.

Wide range of components

The Freeformer can be used to realise sophisticated designs and

complex geometries. Many examples of components will be on

display at Chinaplas 2024, including products for the aerospace industry

made from Ultem 9085. The Freeformer, which is suitable for

clean rooms, can also be used in medical technology, for example to

produce resorbable implants, breast prostheses and medical devices

and aids. Customised multi-material applications such as shoe insoles

made of flexible TPE and a hard zone made of PP are also very

interesting. The APF process is also ideal for sophisticated AM parts

made from semi-crystalline PP.

ARBURG GmbH + Co KG

D 72290 Loßburg

Operating equipment and EOAT in hard/soft combination:

the Freeformer can additively manufacture items such as

individual multi-material grippers for robotic systems.

The Freeformer 750-3X has three discharge units and

additively manufactures resilient functional parts, including

in hard/soft combination and from original plastic granules.


page 30/36

Smallest High-Power Turbopump on

the Market for Integration into

Portable and Mobile Applications

Smallest Hybrid-Bearing High-Power Turbopump HiPace 10 Neo.

The new HiPace 10 Neo turbopump from Pfeiffer Vacuum is a compact

vacuum pump which is ideal for portable and mobile analysis

applications. With its Pfeiffer Vacuum Laser Balancing technology,

the HiPace 10 Neo offers minimal noise and low vibration levels.

Alexander Kreuter, Product Manager at Pfeiffer Vacuum: “As one

of the leading suppliers of vacuum technology, we are proud to present

the upgrade of the smallest turbopump. The purely mechanical

bearing which incorporates oil-lubricated ceramic ball bearings makes

the HiPace 10 Neo extremely reliable, even under difficult conditions

encountered in transport or due to vibrations during operation.

It can withstand even rapid movements or falls.”

With the special Pfeiffer Vacuum accessory interface, Access-

Link, which recognizes accessories automatically, the system can be

up and running quickly in just a few steps.

The HiPace 10 Neo combines compactness, drive efficiency and

intelligence. It thus makes a further contribution to the sustainability

of the turbopump portfolio. For example, the more compact design

and the associated material savings mean that a significant proportion

of CO2 can be saved. By using intelligent sensor technology, the

pump is always operated with the lowest energy input. Thanks to the

intelligent control system, the pumps can be interconnected without

great effort, so that backing pumps and turbopumps interact with

each other. In this way, a complex, IoT-capable vacuum system can

be realized in just a few easy steps.

The HiPace 10 Neo operates with a new high-performance lubricant.

Its improved aging resistance, optimized lubrication behavior

and high temperature resistance guarantee safety and reliability. The

HiPace 10 Neo pumps run maintenance-free for up to 5 years.

Pfeiffer Vacuum GmbH

D 35614 Asslar

Innovative adaptation technology

for more hygienic filling

With its new patented seal system for filling needle and filling pipe systems, valve specialist GEMÜ has brought to market

the first ever adaptation option for filling needles that ensures hermetic separation between the actuator and medium. This

means that any lift effect and contamination of the medium can be avoided.

PD with filling needle adaptation on GEMÜ AF40 actuator

On the basis of the GEMÜ F40 and GEMÜ F60 servoDrive filling

valves, tried and tested PD technology (plug-diaphragm technology)

has been expanded to include a new PD version with a stainless steel

thread, which is pressed directly into the PTFE in the sintering process.

With the new seal system, no more flushing behind the gland

packing seals is consequently required. The danger of contamination

due to lubricants from the actuator or due to the lifting effect is

also avoided. The new GEMÜ PD, in combination with GEMÜ F40

and GEMÜ F60 high-performance actuators, improves the hygiene

and performance of every filling application with filling needle and/

or filling pipe systems, across all media and containers.

Filling needle and filling pipe systems are often used in the fluid

filling applications of liquid and viscous media. This principle is used

primarily in the cosmetics industry, for filling pharmaceutical products

and in the foodstuff industry, for example for dairy products,

juices and sauces. With this new seal system, GEMÜ is make it possible

to elevate the safety, accuracy and speed of the filling process

to a much higher level.

GEMÜ Gebr. Müller Apparatebau GmbH & Co. KG

D 74653 Ingelfingen


page 31/36

Romaco at Achema 2024

Energy and cost-efficient

processing and packaging solutions

Romaco will showcase a wide range of sustainable processing and packaging solutions at this year’s Achema. Thanks to

energy efficient processes that make sparing use of resources, the one stop solutions supplier can considerably improve its

machines’ carbon footprint. The new KTP 420X C containment tablet press from Romaco Kilian will be the highlight at the

upcoming exhibition.

As a one stop solutions supplier, Romaco will be taking advantage

of this year’s Achema to present its broad portfolio of machinery.

From powder processing to the finished pallet, the manufacturer’s

technologies cover the entire process chain in the pharmaceutical,

nutraceutical, food and chemical industries.

The all-in-one machinery supplier strictly focuses on aspects of

sustainable product development. Romaco’s energy efficient technologies

make sparing use of resources and improve the carbon

footprint of its machines while cutting the manufacturing costs for

users. The company’s success in meeting climate change objectives

is audited by independent organizations. Romaco recently earned a

silver medal in the EcoVadis Sustainability Rating and, with a total

score of 67, is among the 11% top-rated businesses. In addition, the

SBTi (Science Based Targets initiative) has confirmed the achievement

of Romaco’s targets for reducing Scope 1 and 2 greenhouse gas

emissions in 2023. In 2024, Romaco also became a member of the

UNGC (United Nations Global Compact).

Kilian KTP 420X C containment press

The containment version of Romaco Kilian’s KTP 420X C rotary tablet

press fulfills all requirements for processing active pharmaceutical

ingredients up to OEB Level 3 with medium toxicological potency.

This includes numerous medications, for example for treating

hypertension, ventricular ulcers or bronchial asthma. The containment

tablet press is configured with a Restricted Access Barrier System

(RABS) featuring glove ports to protect the operator as well as a

Rapid Transfer Port (RTP) for contamination-free material transfer.

Negative pressure in the compaction area and electric door locks

as well as dust-tight docking systems and a dust-tight tablet chute

moreover ensure GMP compliance. The efficient implementation

of high-quality containment processes is additionally supported

by the proven hygienic design of the KTP 420X C. The hermetical

separation between the compaction and technical areas prevents

tablet dust from entering the mechanical compartment. The compaction

area itself is designed as a deep-drawn, single-piece run-off

containment with polished surfaces and large radii, so that far less

effort is necessary for cleaning. Protective clothing is only required

for cleaning the press and is not essential during production. The

very good OEE (overall equipment effectiveness) and extremely low

TCO (total cost of ownership) are key characteristics of the Romaco

Kilian KTP 420X C. With a maximum output of 475,200 tablets per

hour, the technology is classed as a high-speed press for containment

applications.

KTP 1X R&D tablet press from Romaco Kilian

The KTP 1X is the newest generation of Romaco Kilian’s R&D tablet

presses for laboratory use. This single-stroke press was designed as

an all-in-one instrument for research and development activities. It

is suitable for pressing mono-layer, bi-layer and triple-layer tablets

as well as tab-in-tab formats. Depending on the model, it achieves

compression forces of up to 80 kN with a maximum output of 1800

tablets per hour. This versatile R&D press enables the various tableting

parameters, such as compression force or the possible tableting

speed, to be automatically determined. The smart measurement

system evaluates huge amounts of data in next to no time for this

purpose. The KTP 1X is moreover capable of simulating any standard

rotary press, making it much easier to conduct scale-up trials.

In addition to the production of clinical samples, the technology also

allows detailed troubleshooting and hence supports process optimization.

Thanks to the machine’s extremely good rigidity, the punch

position in particular can now be measured more precisely. This high

measuring accuracy goes hand in hand with extremely low product

consumption, which is why the KTP 1X is not only very accurate but

also cost-efficient and sustainable. Only a few test series are required

to obtain meaningful results, as the compression studies are

highly automated. With its very small compaction area, the machine

has a small footprint and is quick and easy to clean – for even greater

time and energy savings. What’s more, the KTP 1X ships with a data

module that gives users access to raw measurement data worldwide

at any time, even when the tablet press is not in operation.

TPR 25 Pilot mobile tablet coater from Romaco Tecpharm

Romaco Tecpharm is expanding its Optima product family with

the TPR 25 Pilot mobile tablet coater. All inlet and exhaust airflow

systems required for the coating process have been integrated into

this compact pilot-scale unit for simple plug & play commissioning.

As a modern all-in-one solution, its applications cover everything

from development activities and scale-ups to the production of

very small batches. The pilot coater is designed to handle batches

weighing anything from 1 to 25 kg, making it suited for an extremely

wide batch size range from 5 to 100 percent. The coating pan’s

enormous flexibility is made possible by fully automated processes

requiring no manual adjustments. The TPR 25 Pilot is equipped

with Tecpharm’s patented Optima spray arm, which is controlled

by a sonar system that automatically adjusts the distance between

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


page 32/36

gence, the coater does not have to be stopped and opened to correct

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

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

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

through the tablet bed follows a precisely controlled path, which

can be automatically adapted to the fill level in the drum with the

aid of an exhaust flap that opens steplessly. This results in remarkably

accurate application of the coating suspension and ultra-efficient

drying of the tablet bed. From a sustainability viewpoint,

Romaco Tecpharm’s TPR 25 Pilot consequently impresses with

significantly shorter processing times coupled with lower energy

and spray liquid consumption.

Unity 600 blister packaging line by Romaco Noack

Unity 600 blister line from Romaco Noack

Romaco Noack’s new Unity 600 blister packaging line combines high efficiency with a sustainable system concept. This double-lane, highspeed

line achieves a maximum output of 600 blisters and 350 cartons per minute and enables flexible processing of blister packs up to 145

mm long and 90 mm wide. Its innovative transfer system eliminates the need for conventional vacuum pumps, significantly improving the

energy efficiency of the monobloc, which consists of a blister machine with rotary sealing and a continuous motion cartoner. The vacuum

for transferring the blisters to the cartoner and for removing the cartons and leaflets is instead produced in a more climate-friendly Venturi

process. Venturi pumps are comparatively small, need less maintenance and give off much less heat, so that the cooling requirements in the

cleanroom are greatly reduced. The blisters are transferred to the cartoner by a carousel-shaped indexing wheel with a downstream stack

transfer unit, which ensures that the cartoner is only supplied with complete blister stacks. As a new feature, any gaps are mapped in the software

and compensated. Since good blisters are no longer held back, a manual blister top-up magazine can be dispensed with. Furthermore,

this highly automated transfer solution allows seamless tracking and tracing of the blisters from the product feeding unit onward. Due to its

very good line clearance and short changeover times, Romaco Noack’s flexible-format Unity 600 blister packaging line also scores with excellent

OEE (overall equipment effectiveness).

VENTILUS® Pilot fluid bed processor

from Romaco Innojet

The VENTILUS® Pilot fluid bed processor from Romaco Innojet

is a mobile all-rounder for pilot scale applications or small batches.

The technology impresses with excellent results in terms of

flow properties as well as powder and granulate compressibility.

Mounted on four wheels, this compact machine fits through any

standard door frame and is designed for plug & play installation.

An all-in-one solution intended for batch sizes from 4 to 25 litres,

it granulates, dries or coats particles of any size from 10 μm to 2

mm. The technology meets all the requirements for laboratory use

as well as for GMP-compliant production of clinical samples. The

spray liquid is applied optionally according to the conventional

top spray method or using a bottom spray system with a central

nozzle – either the ROTOJET® or the new FLEXIJET®. The latter

was specifically developed for granulation processes and is not

only very easy to handle, but also quick to clean. The cylindrical

container featuring the ORBITER® booster permits controlled,

gentle batch intermixing. The homogeneous flow conditions improve

product quality and reduce the spray liquid consumption

while simplifying scale-ups. In addition, the VENTILUS® Pilot

is suited for hot melt coating processes, which merely requires

connection of the patented Innojet IHD hot melt system. The

processing time is consequently up to 85 percent shorter and the

processor’s carbon footprint is significantly lower.

Oftalmica aseptic liquid filling machine by Romaco Macofar

The Romaco Macofar Oftalmica was specially developed for filling

additive-free ophthalmic products but can also handle nasal sprays

and injectables. The machine meets all the requirements of the revised

Annex 1 of the EU GMP Guidelines and can be supplied with

oRABS or isolation technology. The Oftalmica is ideal for filling sterile,

highly viscous and oily suspensions as well as foaming liquids

into narrow-mouth bottles. Its dosing station with up to eight separately

driven rotary piston or peristaltic pumps enables filling in

two phases, which is especially recommended for products with very

poor flow properties. All in all, the Oftalmica achieves a maximum

output of 12,000 bottles per hour with a filling volume of between 1

and 30 ml. To simplify product changes, the formats of the individual

machine stations and the bottle transport system were designed for

a very wide range of container sizes. All parts support plug & play installation

and removal in a few simple steps and can also be sterilized

in an autoclave. Vacuum belt conveyors ensure safe transfer of lightweight

plastic bottles. The Oftalmica can be configured with up to

three closing stations and processes the entire range of ophthalmic

closures, including Aptar and Nemera devices. Torque control is assured

for 100% of the screw caps. Additionally, a 100% weight control

system can be implemented to check the filling volume of the bottles

both before and after filling.

Romaco Group

D 76227 Karlsruhe


page 33/36

Know-how and innovations for the healthcare business

– stay up-to-date along the entire added value chain

MEDICA 2024 + COMPAMED 2024:

International and diverse with

more than 6,000 exhibitors

The healthcare business and the medical technology sector are moving forward with vigour, driven by ever new technical

developments. Innovative, digital and connected – this is how the sector persists against challenging framework and market

conditions. And keeping pace with the industry, MEDICA and COMPAMED are also holding their own as a combination of

globally unique platforms for business and information serving the entire added value chain of medical-technical systems

and products – including manufacture and development. The number of registrations for both trade fairs this year puts expectations

at a total of more than 6,000 companies from 70 countries exhibiting in Düsseldorf from 11–14 November 2024.

“With a volume of approximately 140 billion euros, the market for

medical technology in Europe is extremely important for many of our

exhibitors. Regardless healthcare policy debates, this is equally true

for the German market, which alone accounts for 40 billion euros”,

says Christian Grosser, Director Health & Medical Technologies at

Messe Düsseldorf, explaining why exhibiting companies benefit.

With a view to the professional audience travelling to the events,

Grosser also regards the date in 2024 as set: “In order to be fit for

tomorrow’s healthcare, it is critical to remain up-to-date by way of

networking, knowledge transfer and innovations at the highest level.

MEDICA in Düsseldorf has been providing excellent opportunities

to do this for the better part of half a century.”

At MEDICA 2024, there are five worlds of experience promising

a comprehensive range of innovations for the treatment of outpatients

and clinical use. For a first glimpse, see the database of companies

and products at the MEDICA.de hub, which currently lists

more than 12,700 products and services. The corresponding worlds

of experience at the professional trade fair are: Lab Technology and

Diagnostics, Medical Technology and Electromedicine, Commodities

and Consumables, Physiotherapy and Orthopaedic Technology

as well as IT Systems and IT Solutions.

Held in parallel to MEDICA as always, COMPAMED can look back

on more than thirty years of success and has become an absolute

hotspot for complex high-tech solutions. About 750 exhibiting companies

will present their specialised knowledge as manufacturers

and suppliers at COMPAMED 2024, also in five worlds of experience:

Manufacturing & Devices (e.g., components, parts, manufacturing

processes), Services & Advice (e.g., research, development,

services), Materials (e.g., plastics, glass, ceramics, metals, composite

materials, adhesives, packaging), Micro Tech (such as micro components,

microfluidics) as well as IT in Tech (software development

and maintenance for medical technology).

All trending topics of the year “live on stage”

Dominating market trends are currently causing a huge demand

for information and plenty of issues for debate. MEDICA 2024 and

COMPAMED 2024 will provide a corresponding superb stage programme

with accompanying forums and conferences which bridge

the content gap to exhibitors’ presentations and topic-driven special

exhibitions, for example the ‘Wearable Technologies Show’, the

‘Hospital of the Future’ or the MEDICA SPORTS HUB.

This year, the hot topics at MEDICA include the most recent

examples of AI application and robots and assistive systems in dayto-day

medical practice. Another focus is on the increasing connectivity

in healthcare provision, specifically on innovations for the

point of care, which means diagnostics and treatment in the immediate

vicinity of patients (usually outpatients). This includes telemedical

applications with the aim of providing optimised cooperation

across all sectors by all persons involved in the treatment process.

Another top issue at this year’s MEDICA is the human factor.

The urgent lack of skilled professionals also affects almost all companies

active in healthcare, leading them to search for solutions.

These topics will be discussed in individual forums and at conferences

which are appropriate to each target group.

Fresh ideas for the digital healthcare transformation

Strong trade fair duo for the entire value chain of the

medical technology industry - MEDICA + COMPAMED in Düsseldorf

(© Constanze Tillmann/ Messe Düsseldorf)

Some examples are the MEDICA HEALTH IT FORUM (for IT

topics like big data, artificial intelligence or cybersecurity), the

MEDICA TECH FORUM (trends and topics from science, politics

and business with relevance for the medical technology industry)

or the new MEDICA INNOVATION FORUM. This forum


page 34/36

will replace the former MEDICA CONNECTED HEALTHCARE

FORUM. Because digital innovations are not limited to optimised

connections between all healthcare players, the MEDICA INNO-

VATION FORUM will focus on the digital transformation of the

healthcare industry in its entirety. The popular start-up competitions

remain part of the programme and will shine a spotlight on

fresh ideas and product solutions by the young start-up scene on

the forum stage.

COMPAMED, too, promises excitement, information and open

discussions. The agendas at the COMPAMED HIGH-TECH FO-

RUM and COMPAMED SUPPLIERS FORUM reflect the top issues

of the supply sector such as AI, robotics and automation, new trends

in microtechnology and innovations in materials. And last but not

least, there will be contributions and discussions about the best

practices of international market cultivation. Supply chain management,

questions of product approval and patent law are some of the

relevant aspects.

Last year, MEDICA and COMPAMED recorded a total of 83,000

visiting professionals from more than 160 countries.

Messe Düsseldorf GmbH

D 40001 Düsseldorf

Signaling and indicator lights, switches and buttons – elements that hardly

any machine can do without. The new Ganter cabinet U-handle GN 6284 integrates

all of these functions into a single, compact element.

Compact Integrated:

Light, Switch, Handle

Handles with additional active functions optimize the operation of

systems and machines, simplifying operation and process monitoring.

Precisely for these more complex applications the cabinet

U-handle GN 6284 was designed: It has an integrated button and a

large, colored, backlit area on the back of the handle. The buttons

and the illuminated area are functionally distinct but can also be

used in combination.

For example, the button can be used to acknowledge actions or

request interruptions in operating cycles. The two-channel design

of the switch element increases safety during operation. It is available

either as two normally closed contacts or as a combination of

normally closed and normally open contacts. This way, it can cover a

wide range of applications with DC and AC voltages from 24 to 240

volts and currents of up to 3 amperes, depending on the category of

use and type of connection.

The light element on the back of the handle is made up of a

form-fitting diffusor made of robust polycarbonate that is tightly attached

with an IP 67 protection rating. It homogenously diffuses the

light produced by the interior LED module in a variety of colors and

brightness levels depending on the activation of the 24-volt RGB

matrix. This transforms the handle into a status indicator that is visible

even from the side or from a distance – ideal for large systems

operated with small crews. Depending on how it is wired, the light

signal can indicate problems in the process, signal normal operation

or show that the system is ready to be opened. The colors and functions

can be allocated individually. The extensive documentation and

the video tutorial provided on the Ganter website lay out the many

possibilities.

Of course, Ganter has taken a holistic approach and provided the

illuminated cabinet U-handle with a passive counterpart. GN 6284.1

has the same shape and material (glass fiber-reinforced polyamide)

as its active sibling, allowing for consistent machine design. Speaking

of design: This combination of multifunctionality, design, ergonomics

and versatility was awarded the prestigious iF Design Award

2023.

Otto Ganter GmbH & Co. KG

Triberger Straße 3

D 78120 Furtwangen

Telefon: +49 7723 65070

Telefax: +49 7723 4659

eMail: info@ganternorm.com

Internet: http://www.ganternorm.com


page 35/36

Schreiner MediPharm Extends Innovative Service Solutions to Smart Labels

Flexible and Fast: Late Stage

Customization for RFID-Labels

The pharmaceutical industry is confronted with continually changing market conditions and growing segmentation trends.

That requires flexibility and agility to guarantee security of supply. To support pharmaceutical companies in optimizing

their supply chains, Schreiner MediPharm is presenting an innovative solution: Late Stage Customization for RFID-Labels

enabling sophisticated smart labels to be supplied on short notice and order-specific programming of the integrated RFID

chip.

Schreiner MediPharm, the expert in innovative functional labels, responds

to the challenges of an increasingly fast-changing healthcare

industry by extending its Late Stage Customization Service to RFIDand

NFC-Labels. The labels are initially preproduced in larger volumes

with integrated RFID inlays and warehoused as semi-finished

goods. When requested by the customer the preproduced labels are

subsequently customized by digital printing and delivered on short

notice. This enables flexible production of sophisticated smart labels

and ensures fast response to customer inquiries.

Schreiner MediPharm’s special service not only offers high levels of

customization and short lead times but also ensures reliable performance

of the integrated RFID chips due to continuous quality inspections.

The chips can be individually programmed as needed. In

addition, a combination with preproduced functional labels is possible

as well. That opens up many possible applications: from detachable

documentation labels to integrated hangers for infusion bottles

to integration of functional varnishes and security features.

Thanks to Late Stage Customization of RFID-Labels,

Schreiner MediPharm supports pharmaceutical companies

in optimizing their supply chains. © Schreiner MediPharm

The customized service by Schreiner MediPharm provides the pharmaceutical

industry with numerous benefits. In addition to high levels

of customization and fast deliveries, it reduces process costs.

Because no minimum order quantities are required and warehouse

costs are minimized, pharmaceutical companies benefit from high

flexibility and cost efficiency. The special design of the RFID-Labels

featuring a unique structure to protect the sensitive chip also ensures

RFID performance from production to final use.

Schreiner MediPharm

D 85764 Oberschleißheim

Impressum:

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

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

Original texts and images

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

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

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

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


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