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Cleanrooms for medical technology

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 medical technology, components and products must not only be manufactured with high precision, but also absolutely reliably and cleanly. Whether implants, catheters, surgical instruments or complex medical devices – even the smallest particles, germs or residues can impair function and patient safety.

Depending on the production process – injection molding, additive manufacturing, assembly or packaging – different cleanroom classes are required, usually
ISO 6 to ISO 8 (according to ISO 14644-1) or GMP C and B for particularly critical processes.

Our CleanMediCell cleanroom system was specially developed for the requirements of medical technology. It creates a controlled production environment at all times, is precisely tailored to your processes by our experienced engineers and can be easily expanded if required.

For less critical assembly or packaging steps, our CleanFlowCell cleanroom tent offers a flexible and economical solution with reliable particle protection.

This allows you to meet regulatory requirements, ensure reproducible quality and remain competitive in the long term.

Applications - at a glance

Implants

Medical devices

Packaging and sterilization

Surgical instruments and single use products

Stents

Endoscopy

Request cleanroom for medical technology

Our medical technology cleanrooms in the practice

Karl Storz AG, Estonia
Cleanroom for medical technology, ISO 7
>> more information <<

Artivion (Jotec GmbH)
Cleanroom for medical technology, ISO 7
>> more information <<

Profilectric GmbH
Cleanroom tent for medical products, ISO 7
with sliding doors and integrated airlock 5x3m
>> more information <<

CNC Cleanroom for production of miniature pumps
>> more information <<

Lercher Medical GmbH
Cleanroom for plastics in medical technology, ISO 7
>> more information <<

Lercher Medical GmbH
Cleanroom enclosure for robotics in plastics production, ISO 7
>> more information <<

B. Braun SE
Cleanroom for medical technology, ISO 7
-Read user report-

University of Freiburg
Cleanroom laboratory; ISO 6
>>Watch video<<

CNC Cleanroom for medical technology
>> more information <<

Medartis AG
Cleanroom for implants, ISO 7
>> more information <<

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

Medipack AG
Cleanroom for medical packaging, ISO 8
>> more information <<

eucatech AG
Cleanroom for catheters and stents, ISO 8
>> more information <<

Storz Endoskop Produktions GmbH, Widnau
Cleanroom for medical technology, ISO 8

Swisstronics Contract Manufacturing AG
Cleanroom tent for electronic assemblies, ISO 7

Renggli Bros. AG
Clean room cabin for injection molding in medical technology, ISO 7

Promedical AG
Cleanroom for blistering surgical materials, ISO 8

Our cleanroom solutions

Construction of a cleanroom for medical technology

We accompanied the construction of a cleanroom system with time lapse and drone. In 2.5 minutes, you can see how a cleanroom system measuring over 500 m² is delivered in individual elements and assembled, including air conditioning. In this example, the cleanroom was planned with 16-meter-long trusses to create a self-supporting surface over the entire length.

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 medical technology