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Cleanrooms for the pharmaceutical industry

Q: What is cleanroom technology?

The term cleanroom technology covers all technical and organizational measures that serve to control the number of particles introduced into or generated in the cleanroom. This includes the actual cleanroom system with filter and air circulation systems, but also the structured introduction of materials and personnel, the specification of the materials used, the cleaning of the cleanroom, monitoring and much more. Cleanroom technology therefore covers a much wider spectrum than just the cleanroom itself. A defined quality and safety standard is guaranteed through the use and coordination of the various elements of cleanroom technology. Eliminating the damaging influence of particles and microorganisms ensures significantly higher quality and safety. The use of cleanroom technology is therefore increasingly becoming the key to the reliability and cost-effectiveness of products with high quality requirements. Without controlled production processes under cleanroom conditions, many sensitive products can no longer be manufactured today, such as in the semiconductor industry, microtechnology or medical technology, where even the smallest particle deposits render the end product unusable. Another important aspect of cleanroom technology is the reduction of germs and microorganisms, which is absolutely essential in the manufacture of medicines and pharmaceutical products, but also leads to a significant improvement in quality in the food and cosmetics industries.

Q: What is a cleanroom class according to ISO?

When it comes to cleanrooms, there are various gradations that define the particle purity. These gradations are specified in cleanroom classes according to the ISO standard with the numbers one to nine. The lowest cleanroom class ISO 1 describes the cleanest room and cleanroom class ISO 9 approaches the values of natural air in a room. So if you want to achieve the cleanest of cleanrooms, you need an ISO 1 classification. You can find a detailed overview here Cleanroom class table as PDF .

Q: What is a cleanroom class according to GMP?

GMP (“Good Manufacturing Practice”) is an English term that originally comes from the manufacture of pharmaceuticals and active ingredients. Good manufacturing practice” describes certain guidelines for quality assurance of production processes and environments in the pharmaceutical industry. The cleanroom classes according to GMP are based on the ISO standards in terms of particle concentration, but have additional limit values for harmful microorganisms. In contrast to the ISO standard, GMP cleanroom classes are labeled with the letters A to D. Cleanroom class A describes the highest cleanliness level and cleanroom class D the lowest cleanliness level with the highest maximum permissible particle concentration. To get from the lowest to the highest cleanroom class according to GMP, the intermediate cleanroom classes C and B must also be passed through. An overview of the permitted particle numbers can be found here .

Q: What is a cleanroom class table?

A cleanroom class table is an international standard for classifying cleanrooms according to ISO 14644-1 and GMP. The International Organization for Standardization – ISO for short – is an independent organization dedicated to setting international standards for procedures. The internationally approved particle sizes for the different ISO cleanroom classes and cleanroom classes according to GMP are listed here. So if you want to achieve the cleanest of cleanrooms, you need a cleanroom classification according to ISO 1. To achieve this, samples with 10 or fewer particles with a size of 0.1 micrometers per cubic meter must be detected. From then on, the scale allows for more and larger particles. In the ISO 5 cleanroom class, which meets the very strict requirements for microchip production, for example, up to 100,000 particles of 0.1 micrometers may be measured. Particles of 1.0 micrometers may not exceed 823. Cleanroom class ISO 9 is the “worst” cleanroom class and is considered normal room air. In these rooms, particle sizes of 0.1 micrometers are no longer considered. Allowed here are 8,320,000 or fewer particles of 1 micrometer and 293,000 or fewer particles of 5 micrometers.

In the pharmaceutical industry and in pharmacies, not only product quality, but also personal protection and sterility are top priorities. Whether in the production of active ingredients, sterile medicines, vaccines or diagnostics – even the smallest particles, microbiological contamination or operator influences can jeopardize efficacy, safety and approval.

Depending on the process step – synthesis of active ingredients, production of drugs and cytostatics, filling, sterile assembly or packaging – cleanrooms in accordance with GMP classes A to D and ISO 5 to ISO 8 (in accordance with ISO 14644-1) are required. Both product and personal protection play a central role here.

Our CleanSteriCell cleanroom system offers a comprehensive GMP solution: it creates a controlled production environment that is precisely tailored to your processes, planned and documented in accordance with GMP and can be expanded at any time. Our experienced engineers will support you from planning and implementation through to qualification, GMP documentation and the necessary monitoring.

For less critical steps such as secondary packaging or intermediate storage, our CleanFlowCell cleanroom tent offers a flexible and economical solution with reliable protection against the ingress of particles and germs. CleanProCel laminar flow cabinets create safe working areas with integrated personal protection within the cleanroom environment.

This ensures maximum product quality, compliance with all regulatory requirements and the protection of your personnel – from research to series production.

Applications - at a glance

Cytostatic laboratories

Extraction of active ingredients

Production of medicines

Packaging of medicines

Blistering

Tablet presses

Request a cleanroom for the pharmaceutical industry

Our pharmaceutical cleanrooms in practice

IOZK GmbH & Co KG
Clean room laboratory for cancer diagnostics, GMP B
>> more information <<

Swiss Blister Center
Cleanroom for blistering, GMP B
>> more information <<

Avintos GmbH
Cleanroom for silicone hoses, ISO 9
>> more information <<

Sigmaringen hospital pharmacy
Clean room laboratory for cytostatics, GMP B
>> more information <<

Kunststoff-Packungen AG
Cleanroom booth for pharmaceutical packaging, ISO 7
>> to customer testimonial <<

Hospital pharmacy Havelland Kliniken
Clean room laboratory for cytostatics, GMP B

Röchling Medical Neuhaus GmbH & Co. KG
Cleanroom for pharmaceutical packaging systems, GMP C

Eurozyto GmbH
Clean room laboratory for cytostatics, GMP C

Louis Widmer AG
Test train cabin, GMP D

Cleanroom tent for pharmaceutical filling, ISO 8

Cleanroom tent for pharmaceutical production, ISO 8

Our cleanroom solutions

Germ-free assembly & automated material ejection

In cleanroom production, every detail counts. Incorrect ejection can introduce impurities and jeopardize the entire process. How can produced packaging parts be ejected from the cleanroom fully automatically without jeopardizing the cleanliness of the cleanroom? The video shows the automated process in the production of dosing systems for eye drops in a cleanroom. The individual parts are assembled in automated processes. The finished products are packed into bags by employees and transported out of the cleanroom via a fully automated ejection system. A specially designed, encapsulated conveyor belt system with integrated air filtration secures the process.

We were very satisfied with the advice and support provided during the sales process and project management.

Dr.-Ing.Paul Cvancara, Academic advisor / group leader

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Albert-Ludwigs-University Freiburg

We were impressed by the engineering solutions from SCHILLING ENGINEERING. Despite the delivery bottlenecks, the schedule went well.

Sabrina Beiter, Operational Excellence

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Artivion

We were very satisfied with the handling of the project and the overall package was perfect.

Markus Jäggi, Head of Technology

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avintos AG

The modular construction method with the trusses convinced us.

Thomas Seehuber, ASM / Production planning

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BSH Hausgeräte GmbH

"We are very satisfied with the advice and the quality of the cleanroom. It was also great that the schedule was adhered to."

Dr. Stephan Mingels, Teamleader R&D

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Buehler

From "A" to "Z" it went through cleanly. It was a pleasure!

Markus Zbinden, Head of GF & XRS specialist group

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Comet AG

It was a project under time pressure and everything worked out perfectly. SCHILLING ENGINEERING is already an existing partner and I would like to keep it that way.

Victor Coggi, Director of Technical Department

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Diamond SA

It was a very successful project all round. To put it briefly: Familiar - Competent - Professional.

Adrian Schilling, Operation Manager / Plant Manager

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GEMÜ GmbH

Schilling Engineering gave us very good advice and adapted the system to our circumstances. The price was also right.

Marcus Hutter, Head of Facility Management

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Hagleitner Hygiene International GmbH

We have been working with Schilling Engineering for years because they have the know-how. Here we have one point of contact and one company that delivers everything.

Marcel Lechmann, Head of Special Projects

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Hamilton Bonaduz AG

Modular rooms with a system and an appealing design - definitely an added value! Reliable project work with experience in detail! I can only recommend Schilling to others.

Norbert Ressle, Project Manager Industrial Engineering

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HOERBIGER Antriebstechnik Holding GmbH

We like the modern and flexible cleanroom system. Above all, the project schedule worked very well.

Riivo Ranniku, Director of Operations

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Karl Storz Video Endoscopy

If you have any questions, you can always contact Schilling and a solution will be found. Praise also goes to the service technicians, they are great!

Stefan Burtscher , Business Development

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Lercher Medical GmbH

Service and support run smoothly, which was an important reason to buy from Schilling again. The price-performance ratio is right.

Joseph Spahr, Pre-clinical Drug Product Manufacturing

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Lonza Ltd.

The tents from SCHILLING ENGINEERING are of very good quality, technically and mechanically well made.

Tilo Callenbach, COO

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Medipack AG

The overall package was right - the price, the advice and the entire process.

Thorsten Deja, Production Planner / Leader Cleanroom & Assemblies

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Mitsubishi Chemical Advanced Materials

A huge advantage is that the Cleanroom was constructed with a self-supporting framework. Without supports and pillars, we have flexible space.

Mario Kuisle, Project engineer

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Plansee Group

The quality of the cleanroom and the expansion of the cleanroom absolutely met our expectations and we were also very satisfied with the competence of the service technicians.

Michael Schmidt, Project manager

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promedical AG

The project was an exciting journey towards our Cleanroom. We were able to gain many new experiences, were closely involved from planning to completion and have been enjoying our chic Cleanroom ever since.

Sarah Mühleck, Site management / Vice President

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Storz Endoscope Production, Widnau

Schilling has a good name in the industry and stands for great experience and quality. Our customers were very pleased when they found out who we were building the Cleanroom with.

Claudia Dubois,

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Switzerland Innovation Park Biel/Bienne

We bought from experience. The cleanroom works perfectly and good solutions are always found. We have already commissioned several cleanrooms from SCHILLING ENGINEERING and are very satisfied.

Raphael Tobler, Production manager

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Tegra Medical c/o Stamm AG

FAQ

Cleanroom technology

What is cleanroom technology?

The term cleanroom technology covers all technical and organizational measures that serve to control the number of particles introduced into or generated in the cleanroom. This includes the actual cleanroom system with filter and air circulation systems, but also the structured introduction of materials and personnel, the specification of the materials used, the cleaning of the cleanroom, monitoring and much more. Cleanroom technology therefore covers a much wider spectrum than just the cleanroom itself. A defined quality and safety standard is guaranteed through the use and coordination of the various elements of cleanroom technology. Eliminating the damaging influence of particles and microorganisms ensures significantly higher quality and safety.

The use of cleanroom technology is therefore increasingly becoming the key to the reliability and cost-effectiveness of products with high quality requirements. Without controlled production processes under cleanroom conditions, many sensitive products can no longer be manufactured today, such as in the semiconductor industry, microtechnology or medical technology, where even the smallest particle deposits render the end product unusable. Another important aspect of cleanroom technology is the reduction of germs and microorganisms, which is absolutely essential in the manufacture of medicines and pharmaceutical products, but also leads to a significant improvement in quality in the food and cosmetics industries.

What is a cleanroom class according to ISO?

When it comes to cleanrooms, there are various gradations that define the particle purity. These gradations are specified in cleanroom classes according to the ISO standard with the numbers one to nine. The lowest cleanroom class ISO 1 describes the cleanest room and cleanroom class ISO 9 approaches the values of natural air in a room.

So if you want to achieve the cleanest of cleanrooms, you need an ISO 1 classification. You can find a detailed overview here Cleanroom class table as PDF .

What is a cleanroom class according to GMP?

GMP (“Good Manufacturing Practice”) is an English term that originally comes from the manufacture of pharmaceuticals and active ingredients. Good manufacturing practice” describes certain guidelines for quality assurance of production processes and environments in the pharmaceutical industry.

The cleanroom classes according to GMP are based on the ISO standards in terms of particle concentration, but have additional limit values for harmful microorganisms. In contrast to the ISO standard, GMP cleanroom classes are labeled with the letters A to D.

Cleanroom class A describes the highest cleanliness level and cleanroom class D the lowest cleanliness level with the highest maximum permissible particle concentration. To get from the lowest to the highest cleanroom class according to GMP, the intermediate cleanroom classes C and B must also be passed through. An overview of the permitted particle numbers can be found here .

What is a cleanroom class table?

A cleanroom class table is an international standard for classifying cleanrooms according to ISO 14644-1 and GMP. The International Organization for Standardization – ISO for short – is an independent organization dedicated to setting international standards for procedures. The internationally approved particle sizes for the different ISO cleanroom classes and cleanroom classes according to GMP are listed here.

So if you want to achieve the cleanest of cleanrooms, you need a cleanroom classification according to ISO 1. To achieve this, samples with 10 or fewer particles with a size of 0.1 micrometers per cubic meter must be detected. From then on, the scale allows for more and larger particles. In the ISO 5 cleanroom class, which meets the very strict requirements for microchip production, for example, up to 100,000 particles of 0.1 micrometers may be measured. Particles of 1.0 micrometers may not exceed 823. Cleanroom class ISO 9 is the “worst” cleanroom class and is considered normal room air. In these rooms, particle sizes of 0.1 micrometers are no longer considered. Allowed here are 8,320,000 or fewer particles of 1 micrometer and 293,000 or fewer particles of 5 micrometers.

Cleanrooms for the pharmaceutical industry