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: