Posted by nadina
Posted on 17th February 2020
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In short, very clean, indeed. Our two separate Cleanrooms are both validated to ISO 14644-1 Class 7 (at rest). This classification is based on the air change rate and the size and concentration of particles in the air. Adhering to strict regulations requires the use of specialised high-efficiency particulate air (HEPA) dust-removing filters and pumps, coupled with total risk management, diligence and testing.
This classification is important in producing materials for both sensitive electronics and those used in medical applications such as diagnostic devices or wound dressings. When the end product will be in direct contact with human skin, especially wounds, they must be made in appropriate regulated conditions.
Our Cleanrooms are externally validated twice per year; including a series of tests to qualify if the controlled environments are performing in accordance with process requirements and the applicable regulatory guidelines of the ISO 14644-1:2015 standards to Class 7.
We also conduct internal tests on a monthly basis, so we can give our customers an additional peace of mind. As a part of our scheduled monthly tests, we check the following:
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.
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).
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:
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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