TESTING STANDARDS
– USP 795: Pharmaceutical Compounding – Nonsterile Preparations
– USP 797: Pharmaceutical Compounding – Sterile Preparations
– USP 800: Pharmaceutical Compounding – Hazardous Preparations
– NSF/ANSI-49: Laminar Flow – Biohazard Cabinetry
– ANSI/ASHRAE 110: Method of Testing Performance of Laboratory Fume Hoods
– CAG-002: CETA – Compounding Isolator Testing Guide
– CAG-003: CETA – Certification Guide For Sterile Compounding
– CAG-005: CETA – Servicing Hazardous Drug Compounding Primary Engineering Controls
– CAG-008: CETA – Certification Matrix for Sterile Compounding Facilities
– CAG-009: CETA – Certification Application Guide USP <797> Viable Environmental Sampling & Gowning Evaluation
– ISO 14644-1: Cleanrooms & Associated Controlled Environments – Classification of Air Cleanliness by Particle Concentration
– ISO 14644-2: Cleanrooms & Associated Controlled Environments – Monitoring to Provide Evidence of Cleanroom Performance
– ISO 14644-3: Cleanrooms & Associated Controlled Environments – Test Methods
– ISO 14644-4: Cleanrooms & Associated Controlled Environments – Design, Construction & Start-up
– 29 CFR: Occupational Health & Safety Act
– ASHRAE Chapter 7: Health Care Facilities (Infectious Isolation Rooms)
– OSHAPD: Title 24 – Part 4, Chapter 4 – Ventilation Air Supply (Negative-pressure Isolation Room)
– Cal/OSHA: Interim Tuberculosis Control Enforcement Guidelines (Atmospheric Isolation)
– AIA: Guidelines for Design & Construction of Hospitals & Health Care Facilities (Airborne Infection Isolation Room)
– CDC: Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-care
– Related to Air Cleanliness by Particle Concentration
– IEST-RP-CC001.5: HEPA & ULPA Filters
– IEST-RP-CC002.3: Unidirectional-Flow Clean-Air Devices
– IEST-RP-CC006.3: Testing Cleanrooms
– IEST-RP-CC0013.2: Calibration Procedures & Guidelines for Select Equipment Used in Testing Cleanrooms & Other Controlled Environments
– IEST-RP-CC0034.3: HEPA & ULPA Filter Leak Tests