Cleanroom Quality Control

Cleanroom Quality Control

Posted by nadina
Posted on 17th February 2020
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    • Particle count test

      We use a device which records the number and size of particles in the air. Given the sizes of our Cleanrooms, we need to make sure every part of them remains compliant. We conduct this test in multiple locations in both Cleanrooms each month and keep a meticulous record of the results. While the results vary depending on the testing location, we always make sure the levels remain within the strict criteria.

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    • Airflow test

      Maintaining ISO 14644-1 Class 7 conditions requires 60-90 air changes per hour. In order to achieve this, the air filters and pumps must maintain their output at a carefully calibrated level. Much like the particle test, we conduct this test at multiple locations in each Cleanroom, and record the values each month to ensure consistent performance. To help with early detection of any potential problems, we run a quick version of this test weekly. The weekly test checks the airflow to ensure filters are not blocked (“blinded” is the official term for it).

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    • Environmental Monitoring

      Environmental monitoring checks for microbial life in the Cleanroom environment. This test involves using plates similar to Petri dishes which contain a growth medium, taking samples at the factory and sending them to a specialist lab, Microbiological Validation Services. We run 3 different types of tests as a part of Environmental monitoring:

      • Settle plates – where we leave a plate exposed to the air for a set amount of time and check whether any microorganisms have grown.
      • Contact plates – where we dab the plate to the machine surfaces and monitor for growth of any microorganisms.
      • Finger check plates – similar to the above, but instead of taking a dab of a machine surface, the personnel handling the product dab their gloved fingers on to the plate and we monitor whether anything grows. We carry out the test across the different production shifts and lines.
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  • Our internal testing and schedule frequency exceeds the requirements of ISO 14644-1 Class 7 accreditation. However, we understand some customers, especially in the wound care market, may have additional testing requirements and we are always happy to discuss these along with any risk assessments you may require.

    Should you require any further information, please contact us.

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