Expertise in Cleanroom validation
Cleanroom validation
An essential part of production for life sciences and high-tech industries is cleanrooms. They play an important role in the safe and sterile production of chips to vaccines. Depending on the process requirements, a cleanroom is required to have a certain purity class or grade and meet the corresponding criteria.
NathanProject Manager MoVE
Curious about which parameters our team tests? That depends on which variables are crucial to your organisation's processes. In any case, our experts check whether all parameters meet the set requirements.
Parameters of cleanroom validation
According to the ISO classification, a cleanroom is a room where the amount of particles is controlled. This means that particle counts have to be conducted when classifying a cleanroom.
In short, cleanrooms are classified on a particle count basis set out in standards, the most common of which are ISO 14644-1 and GMP grades, as described in Eudralex Volume 4 Annex 1. During an inspection, it must be demonstrated that this classification meets the requirements of the activities taking place there.
In addition to particle counts, many other critical parameters are tested to ensure proper cleanroom conditions and hygiene. Possible parameters include:
Microbial contamination
Temperature
Relative humidity
Air flows
Pressure
Brightnesses
Ready for the future?
Future-focused Cleanroom Expertise
Is your organisation prepared for the future of pharmaceutical and high-tech production? For many hospitals, laboratories, startups, and other organisations, building and validating a cleanroom according to (new) regulations can be a daunting step into the unknown, often lacking specific expertise.
By partnering with Normec, you gain access to expertise and support to successfully navigate your cleanroom project. Ensuring quality during the implementation of changes and improvements in an innovative and validated production environment is essential. This contributes to improved long-term cost efficiency, as every decision can impact the final commissioning.
With this accumulated experience, we have developed our own Cleanroom Implementation Blueprint (CLIMB) to advise and support cleanroom project teams throughout the entire process, along with associated deliverables.
Cleanroom Validation Tests
With high-end calibrated test equipment from our MoVE department and years of hands-on expertise, you can trust our team to expertly qualify and validate your cleanroom.
Viables: micro-organisms
Non-viables: particle counting
Filter integrity testing
Recovery testing
Air changes
Testing of flow cabinets
LAF-cabinets
Biosafety cabinets
Powder extraction cabinets
Fume hoods
