Cleanroom Certification

ISO 14644-1 certification, HEPA airflow/integrity, room air exchange rate, room pressurization.

Environmental Monitoring

Routine (monthly, quarterly, etc.) particle count testing, viable air and surface sampling, temperature and humidity testing, or any other testing requested.

Equipment Certification

Testing and certification of various types of clean benches and laboratory hoods, including biological safety cabinets, laminar flow benches, fume hoods, and other HEPA filtered equipment.

Consulting

Review of new construction and remodel plans for sterile compounding facilities and medical device manufacturing cleanrooms.

USP 797/800 Certification

Certification of sterile compounding facilities to CETA CAG-003. Includes standard cleanroom certification testing, viable air and surface sampling, clean bench (PEC) certification, and dynamic airflow visualization studies.

Cleanroom Qualification

Creation and execution of formal protocols (IQ/OQ) for qualification of cleanrooms and controlled environments.