This image depicts an active viable air sample being performed in a Compounding Aseptic Isolator (CAI). USP<797> recommends sampling 1,000 liters of air per location. Collecting 1,000 liters eliminates the CFU per m3 calculation.
Viable environmental monitoring is extremely important in compounding pharmacies and other controlled environments. Precision Air Technology has three technicians accredited by CETA National Board of Testing as Registered Cleanroom Certification Professional for Sterile Compounding Facilities. The services we offer are:
- Surface and Air Sampling for bacteria and fungi
- Compressed Air Sampling for bacteria and fungi
- Consultation in developing a viable sampling plan
We work with an independent environmental laboratory to incubate and read the project samples. They issue an easy-to-read professional test report which details any growth identified to its species.
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.