Environmental Monitoring and ISO 14644 Certification Services for NIH Center for Cellular Engineering (CCE)

The National Institutes of Health (NIH) is seeking a contractor to provide environmental monitoring and ISO 14644 certification services for the Center for Cellular Engineering (CCE) facilities. The contractor will be responsible for ensuring that the facilities meet the room classification standards established under ISO 14644 and are fit for aseptic processing operations. The services include sampling air quality, performing viable and non-viable air sampling, calculating air changes per hour, conducting HEPA filter integrity testing, and measuring differential pressures between controlled rooms. The contractor will also provide a comprehensive certification package for each facility. Some of the key tasks and deliverables include: • Sampling air quality for non-viable particulates • Performing viable and non-viable air sampling • Calculating air changes per hour (ACH) for each critical room • Conducting HEPA filter integrity testing • Measuring differential pressures between controlled rooms • Testing Biological Safety Cabinets (BSCs) in accordance with NSF/ANSI 49 standards • Providing detailed reports documenting all testing performed, results obtained, and confirmation that each room meets its designated ISO classification and applicable FDA requirements