Cleanroom Validation Services
Euro Caltech offers clean room validation services to ensure compliance with applicable requirements and ensure facilities are audit ready and in compliance with regulatory bodies' requirements. The process involves airflow measurement and airborne particle count, as well as additional tests such as filter leakage, air pressure difference, airflow direction, microbial contamination, temperature, relative humidity, recovery testing, and containment leak testing.
The gold standard for cleanroom validation is to test the cleanroom through all three operational states, including at rest, in operation, commissioning tests, and environmental controls. The recommended frequency of cleanroom validity includes the following tests: particle counting, air pressure, air flow testing, filter integrity test, containment leak, airflow visualization, recovery time, particle deposition, segregation, customer monitoring, air pressure, daily monitoring, particle count, regular monitoring, and regal monitoring.
The Light Scattering Air Particle Counter (LSAPC) is used to measure airborne particulate, while air flow testing measures air volume supply rates or air velocity rates depending on the design of the cleanroom. Filter integrity tests ensure that HEPA and ULPA filters have not been damaged during installation and that the installation has been successful with a good seal to the filter housing. ISO Cleanroom has both a calibrated photometer and LSAPC, which can conduct these tests depending on the process's sensitivity to outgassing.
Containment leak tests detect intrusion of unfiltered air into the cleanroom from outside the cleanroom, such as wall joints, doors, ceilings, and windows. The choice of tests depends on the process's sensitivity to outgassing. The recovery test is intended to ensure that the installation can restore to a defined cleanliness level after being briefly exposed to an airborne particle challenge source. The Laskin generator or microspheres can be used to produce a cold oil aerosol challenge, depending on the susceptibility of the operation to outgassing.
Airflow visualization tests show the airflow direction and/or pattern in comparison to the cleanroom or clean air equipment design. This is demonstrated by using the Laskin generator to produce a cold oil aerosol that can be photographed and videotaped to demonstrate the flow. In cleanrooms where outgassing is a concern, a taper or streamer can be used.
Euro Caltech provides clean room validation services to clients, ensuring compliance with applicable requirements and ensuring compliance with regulatory bodies' requirements. They offer a comprehensive range of cleanroom testing and validation services, including particle counting, air flow testing, containment leak testing, airflow visualization tests, recovery tests, and airflow visualization tests. By implementing these measures, clients can ensure their cleanrooms meet the highest standards for compliance with ISO and EU GMP standards.