(A) Total Particle Counts: Certification that your clean room meets each ISO classification area, e.g, ISO Class 5, ISO Class 7, and ISO Class 8 is within established guidelines and should be performed no less than every 6 months.

(B) Ventilation Survey: Verification and certification of positive or negative pressure flow rates, air changes per hour in each clean room to determine ISO classification, and air exchanges per hour. Testing also includes biological safety cabinet, Class II flow rate certification. Testing is based on NSF/ANSI, ASHRAE, NFPA, & ISO requirements and should be performed every 6 months.

(C) HEPA Filter Testing: Verification of HEPA filter(s) integrity, including flow efficiency, penetration testing, and leak detection.

(D) Microbiological Air Sampling: Evaluation of airborne microorganisms in the controlled air environments (LAFWs, CAIs, BSCs, buffer or clean areas, and anterooms/areas). All testing will be conducted using impact active air samplers.

(E) Written Report: A detailed, formal written report will follow each certification session.