Pharmaceutical production - Cleanroom material testing
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Ensure that your materials and equipment comply with the requirements specified in ISO 14644 and EU GMP Annex 1
Danish Technological Institute (DTI) can help you document that materials and equipment do not emit particles or harmful substances to cleanrooms during use or after repeated cleaning and disinfection.
Many materials emit particles during use, and repeated cleaning can gradually degrade materials and increase particle emission over time. This can result in the cleanroom no longer complying with its classification under ISO 14644 or EU GMP Annex 1.
Danish Technological Institute offers specialised testing according to ISO 14644 and EU GMP Annex 1, providing you with the necessary documentation for qualification, certification, and quality assurance — for particles and microbial cleanliness.
How can Danish Technological Institute help you?
- Measurement of particle release from materials and equipment.
- Simulation of repeated use of equipment in cleanrooms, followed by measurements.
- Simulation of repeated cleaning and disinfection, followed by measurements.
- Documentation for classification, certification, and re-certification of cleanrooms according to ISO 14644 and EU GMP Annex 1*.
- Testing of building materials, production equipment, hospital equipment, and furniture.
- Analysis of emission of volatile organic compounds (VOC) and chemicals.
- Advice on material selection for cleanroom environments, including compliance with requirements for particle and microbial cleanliness (total viable count) according to EU GMP Annex 1*.
*EU GMP Annex 1: Manufacture of Sterile Medicinal Products
Testing in a specially designed chamber with precision measurements
When working in cleanrooms, even the smallest particle can be critical. Particle emissions from materials and equipment could compromise a cleanroom classification.
Tests are carried out in a unique 20 m³ test chamber with Teflon-coated walls. Teflon ensures that particles do not adhere to the surfaces. This means that all measured particles originate from your product — not from the test environment. The chamber has room for equipment with a length, width, and height of up to 2 metres.
We imitate the use in accordance with your own instructions: opening and closing doors, operating lifts and production equipment, repeated cleaning and disinfection according to your protocols. This approach reveals whether a material can resist use over time — not only in a laboratory test, but also during real operating conditions.
We use particle counters to carry out measurements, and they provide real-time data throughout the entire test period. The data demonstrates how particle emissions develop during normal operation and after repeated treatment
“Our customers do not just receive a test result — they come to an understanding of how their products will perform after being used for months in a cleanroom environment. However, most enquiries involve documenting that the equipment complies with a given cleanroom class under defined operating conditions”, Kristina Dobroslava Sørensen, Product Manager, Danish Technological Institute.
From dialogue to documentation in four weeks
We have streamlined the process, so you quickly receive the documentation you need:
- Dialogue and needs clarification: We begin with a non-binding conversation about cleanroom class, use scenarios, materials, and cleaning products.
- Quotation and planning: You will receive a quotation including a schedule and deliverables.
- Testing and measurement: Once we have received your product, material testing typically takes 3–4 weeks. We will keep you updated throughout the process.
- Report and documentation: You will receive a report containing all measurements, analyses, and conclusions. The documentation is ready for use in certification processes and regulatory approvals.
Cleanroom classes and GMP requirements
We test materials and cleanroom equipment in relation to all ISO 14644 cleanroom classes — from the most demanding ISO Class 1 through ISO Class 9. Our test methods comply with the requirements of ISO 14644 and EU GMP Annex 1.
Cleanroom particle testing according to ISO 14644: We measure particle emissions and document that materials comply with the specifications of the relevant cleanroom class. This is the core of the certification process.
VOC analysis as a supplement: In addition to particle measurements, we offer analysis of volatile organic compounds (VOC). This provides information about chemical emissions, especially after disinfection. Some disinfectants can react with surfaces and release chemical substances that could have an impact on the production process and employees.
Many industries depend on material testing, and they comprise medical devices, pharmaceuticals, electronics, aerospace, as well as suppliers of building materials and cleanroom furniture.
Read more about our Occupational Health and Safety (OHS) measurements regarding chemical components.
Microbial cleanliness according to EU GMP Annex 1
When cleanrooms are used for the manufacture of sterile medicinal products, they must comply with the requirements of EU GMP Annex 1 that i.a. describes:
- Classification of cleanrooms (A–D)
- Monitoring of the environment
- Limits that apply to particle and microbial contamination (total viable count)
Danish Technological Institute can help test whether your product complies with the current Annex 1 limits for microbial cleanliness in the relevant cleanroom classes (Grade A–D).
Material testing at Danish Technological Institute is used by manufacturers within:
Medical devices and the pharmaceutical industry: Production equipment for pharmaceuticals and medical devices. Hospital equipment such as beds, operating tables and cabinets. Cleaning robots for hospitals.
Electronics and aerospace: Production equipment for electronics manufacturing. Components for the aerospace industry. Precision equipment for cleanroom environments.
Building materials and installations: Insulation materials. Ceiling tiles and wall panels. Flooring materials. Doors, windows and installations.
Furniture and equipment: Tables, chairs and workstations. Cabinets and storage systems. Transport equipment and trolleys. Tools and handling equipment.
Frequently asked questions about cleanroom material testing
Can you test in relation to all cleanroom classes?
Yes, we test materials and equipment in relation to all cleanroom classes according to ISO 14644 — from Class 1 to Class 9 — as well as EU GMP, Grades A to D. We adapt the test protocol to the specific cleanroom class in which your product will be used, so you receive the documentation you need.
Can you simulate an ageing process? Yes, we simulate wear through repeated use, exposure to cleaning and disinfection chemicals, and UV light. This gives a convincing impression of how materials will perform over time. Many of our customers experience that materials look fine at the beginning but degrade after prolonged use. This is revealed by our tests before a problem arises in the production process.
Is it possible to test large equipment? Our test chamber is 20 m³ and there is room for equipment with a length, width and height of up to 2 metres. Therefore, we can test most types of cleanroom inventory and equipment, including hospital equipment and furniture. Do you have something even larger? Contact us, and we will find a solution.
How long does it take to test our product? When we have received your product, and the quotation has been accepted, then it typically will take 3–4 weeks to complete the test and deliver the results. Do you have a tight deadline? Please contact us — we can often prioritise urgent cases.
What is the difference between particle testing and a VOC analysis? Particle testing measures the concentration of airborne particles present in the air. This requirement is specified in ISO 14644 and is crucial for cleanroom classification. A VOC analysis measures the volatile organic compounds in gas form (chemical emissions). It is not an ISO requirement but may be relevant for product quality as well as the working environment, especially after disinfection. Many disinfectants can react with surfaces and emit chemical substances.
Should I send my product to DTI, or will you visit us? The tests are carried out at Danish Technological Institute in our specially designed test chamber. You send or deliver the product to DTI, and then we will carry out the test in a controlled environment. This ensures reliable and reproducible results that can be used in a certification process.
Can my material be used in a cleanroom? It depends on the cleanroom class and application. In general, materials must be sealed, easy to clean and not emit particles during normal use. However, you can only be sure, if you get the material tested.
Please contact us for a non-binding discussion about your specific requirements. We would be happy to update you on testing and documentation of materials for cleanroom environments.
Contact Kristina Dobroslava Sørensen for an initial meeting about your needs.