This in an image of air sampling being done in a biological safety cabinet. USP<797> requires 1000 litre samples inside ISO Class 5 environments like safety cabinets.
Microbial sampling is extremely important in many cleanrooms, pharmacies and controlled environments. Precision Air Technology has three technicians who are certified by CETA to perform certifications in USP<797>pharmacies. The tests we offer are:
- Surface Sampling for bacteria and fungi
- Air Sampling for bacteria and fungi
- Compressed Air Sampling for bacteria and fungi
We work with an independent lab to read our sample plates and issue a test report with the findings. We can do sampling not only in cleanrooms and pharmacies, but anywhere such testing is needed.
The Controlled Environment Testing Association (CETA) is headquartered in Raleigh, North Carolina. CETA provides training classes and offers accreditation programs through the CETA National Board of Testing (CNBT). Precision Air Technology does performance testing in <USP 797> and <USP 800> compounding facilities and has three, CNBT-Registered Cleanroom Certification Professionals for Sterile Compounding Facilities on staff.
Making sure that the product being compounded is bathed in non-turbulent, HEPA-filtered air is a focus of <USP 797> testing guidelines. This air is often referred to as “first air.” This image demonstrates the concept of “first air” through a smoke study done while a lab technician is working. Such testing helps the pharmacy technician define their work space and work practices. Some of our largest <USP 797> testing projects are in university hospital pharmacies.
<USP 797> specifications require that ceiling tiles in compounding pharmacies be caulked in place to prevent contamination getting into the room from the area above the ceiling. Testing the HEPA filters often requires having access to the top of the filter. Instead of cutting the seal to remove a tile, Precision Air installed individual PAO injection ports in a ceiling tile. This made the job easier, and made it safer for the users, the room and the products being manufactured in it.