United States Pharmacopeia sets national guidance for sterile drug compounding which is enforced by each state. Secondary engineering controls (the cleanrooms) and primary engineering controls (Laminar Air Flow Workbenches, Biological Safety Cabinets, and Compounding Aseptic Isolators and Compounding Aseptic Containment Isolators) are used to provide the critical aseptic compounding environments.
Regulatory Guidance / Test Methods:
- United States Pharmacopeia Chapter 797
- NSF/ANSI Standard 49
- CETA CAG-002
- ISO 14644
- ISO 14698
- IEST Contamination Control RPs
All primary and secondary engineering controls tested at least every six months or when modified.
Secondary engineering control certification includes total particle counts (ISO Class 7 or Class 8), supply HEPA filter airflow, room air changes, HEPA filter leak tests, room pressurization, and air / surface microbial sampling.
Primary engineering control certification generally depends upon the device. Biological Safety Cabinets (BSCs) are tested to NSF/ANSI Standard 49, unidirectional airflow isolators are tested to CETA-CAG-002 guidance, laminar air flow workbenches are tested using IEST RP-CC002 guidance. Additionally, all primary engineering controls are tested for total particle counts (ISO Class 5 certification) and have air / surface microbial sampling.
Repairs, including filter and parts replacement, are available for biological safety cabinets, laminar air flow workstations, and compounding aseptic isolators.