Immunology and Microbiology Cleanrooms
Large clinical-scale cleanroom operations for T cell therapies often use a class ISO 7 (Class 10,000) cleanroom room environment with an ISO 5 (Class 100) biological safety hood.
Large clinical-scale cleanroom operations for T cell therapies often use a class ISO 7 (Class 10,000) cleanroom room environment with an ISO 5 (Class 100) biological safety hood.
USP Chapter 797 cleanroom design requires that facilities pressurize non-hazardous compounding and storage areas. ISO 5, 7 and 8 environments support primary engineering controls, buffer rooms, and ante-rooms. Updated: 4/18/2019
Facilities unpacking hazardous drugs within a negative pressure room do not require procedural changes to meet USP unpacking area requirements. Facilities unpacking HDs within positive pressure ante rooms or facility spaces will require reconsideration.