Cleanroom Testing and Certification
Cleanrooms are controlled environments designed to limit airborne particulates and provide other environmental conditions that address contamination and safety. Cleanrooms are certified to a specific class based on ISO standards and/or similar standards (U.S. Pharmacopeia/USP for pharmacies). The room must perform in a way that meets or exceeds the ISO parameters to maintain compliance.
Cleanroom certification testing involves checking that the cleanroom is functioning to the specific parameters and ISO classification. The room is initially certified when originally constructed. The room is then routinely recertified (annually or semiannually) or after any contamination incident to ensure the environmental quality parameters have not changed during occupancy.
Compliance Certification Testing addresses the room and the equipment in that room. Compliance Certification Testing verifies airflows, room design, pressurization, HEPA integrity/leaks, non-viable and viable sampling, temperature and humidity, deep cleaning, training, consulting, repairs, air balancing and documentation.