Question

KNOW: Per USP 797, if an area has an ISO Class 5 recirculating device, a minimum of ____ ACPHs through the area supplying HEPA filters is adequate, provided the combined ACPH is not less than _____.

Answer 1

USP 797 standards require an ISO Class 5 environment to have a specific number of air changes per hour along with HEPA filtration to ensure a controlled environment for sterile compounding.

Step-by-step explanation:

The question pertains to the United States Pharmacopeia (USP) 797 standards for an ISO Class 5 recirculating device and air changes per hour (ACPH) in areas supplying High-Efficiency Particulate Air (HEPA) filters. The USP standard referenced ensures that environments where sterile compounding occurs maintain a specific level of air cleanliness to reduce the risk of contamination.

While the precise numbers required for the minimum ACPH are not provided in the information given, the general requirement is that an ISO Class 5 environment should have sufficient ACPH along with HEPA filtration to ensure a highly controlled environment, free from microbial contamination. Per USP 797, if an area has an ISO Class 5 recirculating device, a minimum of 30 air changes per hour (ACPH) through the area supplying HEPA filters is adequate, provided the combined ACPH is not less than ≥2,000 ACPH.