ISO – International Organization for Standardization
- ISO 14644-1 Classification of Air Cleanliness
- ISO 14644-2 Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1
- ISO 14644-3 Test Methods
- ISO 14644-4 Design, Construction and Start-up
- ISO 14644-5 Operations
- ISO 14644-7 Separative Devices (clean air hoods, gloveboxes, isolators and mini-environments
- ISO 14698-1 Biocontamination Control General Principles and Methods
IEST – Institute of Environmental Sciences and Technology
- IEST-RP-CC001: HEPA AND ULPA FILTERS
- IEST-RP-CC002: UNIDIRECTIONAL-FLOW CLEAN-AIR DEVICES
- IEST-RP-CC003: GARMENT SYSTEM CONSIDERATIONS FOR CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS
- IEST-RP-CC006: TESTING CLEANROOMS
- IEST-RP-CC007: TESTING ULPA FILTERS
- IEST-RP-CC012: CONSIDERATIONS IN CLEANROOM DESIGN
- IEST-RP-CC013: CALIBRATION PROCEDURES AND GUIDELINES FOR SELECT EQUIPMENT USED IN TESTING CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS
- IEST-RP-CC018: CLEANROOM HOUSEKEEPING: OPERATING AND MONITORING PROCEDURES
- IEST-RP-CC019: QUALIFICATIONS FOR ORGANIZATIONS ENGAGED IN THE TESTING AND CERTIFICATION OF CLEANROOMS AND CLEAN-AIR DEVICES
- IEST-RP-CC023: MICROORGANISMS IN CLEANROOMS
- IEST-RP-CC026: CLEANROOM OPERATIONS
- IEST-RP-CC027: PERSONNEL PRACTICES AND PROCEDURES IN CLEANROOMS AND CONTROLLED ENVIRONMENTS
- IEST-RP-CC034: HEPA AND ULPA FILTER LEAK TESTS
- IEST-RD-CC011: A GLOSSARY OF TERMS AND DEFINITIONS RELATING TO CONTAMINATION CONTROL
- IEST-G-CC1001: COUNTING AIRBORNE PARTICLES FOR CLASSIFICATION AND MONITORING OF CLEANROOMS AND CLEAN ZONES
USP – United States Pharmacopeia
- General Chapter <797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS
- General Chapter <800> HAZARDOUS DRUGS-HANDLING IN HEALTHCARE SETTINGS
- General Chapter <795> PHARMACEUTICAL COMPOUNDING-NONSTERILE PREPARATIONS
- General Chapter <825> RADIOPHARMACEUTICALS-PREPARATION, COMPOUNDING, DISPENSING, AND REPACKAGING
- General Chapter <1066> PHYSICAL ENVIRONMENTS THAT PROMOTE SAFE MEDICATION USE
- General Chapter <1116> MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS
CDER – U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research
- 503A: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (July 2014)
- 503B: Current Good Manufacturing Practice-Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Food, Drug, and Cosmetic Act (July 2014)
CETA – Controlled Environment Testing Association CAG – CETA Applications Guides
- CAG-001: Applications Guide For The Use Of Compounding Isolators In Compounding Sterile Preparations In Healthcare Facilities
- CAG-002: Compounding Isolator Testing Guide
- CAG-003: Sterile Compounding Facilities
- CAG-004: Biological Decontamination and Disinfection of Accessible Surfaces in Biosafety Cabinets
- CAG-005: Servicing Hazardous Drug Compounding Primary Engineering Controls
- CAG-006: High Efficiency Filter Application Guide
- CAG-007: Exhaust System Requirements of Class II Biosafety Cabinets
- CAG-008: CETA Certification Matrix for Sterile Compounding Facilities
- CAG-009: Viable Environmental Monitoring for Sterile Compounding Facilities
- CAG-010: Application Guide for Informational Notes to Meet the NSF/ANSI 49:2010a Standard Requirements
Others
- NSF/ANSI 49: Biosafety Cabinetry: Design, Construction, Performance, and Field Certification
- ANSI/AIHA Z9.5: Laboratory Ventilation
- SEFA 1: Scientific Equipment & Furniture Association Recommended Practices For Laboratory Fume Hoods
- SEFA 9: Scientific Equipment & Furniture Association Recommended Practices For Ductless Enclosures
- ASHRAE 110: Method of Testing Performance of Laboratory Fume Hoods
- NIOSH ALERT Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings
- FDA Aseptic Processing Guide
- BMBL – Biosafety in Microbiological and Biomedical Laboratories
