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Simplifying Standards

Simplifying Standards is your go-to resource for understanding the complex world of controlled environment testing. Whether you're a seasoned certifier or new to cleanrooms, biosafety cabinets, and other critical environments, this page breaks down the key standards that guide our work—like ISO, NSF, NAPRA, and EU GMP—into simple, practical language. Our goal is to make compliance clear, testing requirements understandable, and decision-making easier for both technicians and customers alike.

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Cleanroom & Controlled Environments

ISO Standards

ISO 14644-1: Classification of air cleanliness by particle concentration
ISO 14644-2: Monitoring to provide evidence of cleanroom performance related to air cleanliness
ISO 14644-3: Test methods
ISO 14644-4: Design and construction of cleanrooms
ISO 14644-5: Operations
ISO 14644-7: Separative devices (clean air hoods, gloveboxes, isolators, mini-environments)
ISO 14644-8: Classification of airborne molecular contamination
ISO 14644-9: Classification of surface particle cleanliness
ISO 14644-10: Classification of surface cleanliness by chemical concentration
ISO 14644-12: Classification of air cleanliness by nanoscale particle concentration
ISO 14698-1 & 2: Biocontamination control

Pharmaceutical & Compounding Guidelines

International

EU GMP Annex 1: Manufacture of sterile medicinal products
WHO Technical Report Series (TRS): Annexes on good manufacturing practices for sterile products

United States

USP <797>: Pharmaceutical compounding – sterile preparations
USP <800>: Hazardous drugs – handling in healthcare settings
USP <795>: Non-sterile compounding (less relevant for environmental testing, but still good to know)
FDA Guidance: Aseptic processing guidelines

Canada

NAPRA Model Standards:
- For sterile compounding
- For hazardous sterile preparations
- For non-hazardous preparations

Microbiological Safety & Containment

NSF/ANSI 49: Biosafety Cabinetry – Design, construction, performance, and field certification
CSA Z316.3: Certification of biological safety cabinets (Canadian version aligned with NSF 49)
PHAC CBS (Canadian Biosafety Standards):
- Level 2, 3, 4 containment requirements
- Decontamination protocols
- Puff-back prevention (in development/discussion)
CDC/NIH BMBL (Biosafety in Microbiological and Biomedical Laboratories): U.S. standard for lab biosafety

HVAC & Filtration Standards

ASHRAE 170: Ventilation of healthcare facilities
ASHRAE 52.2: Method of testing air-cleaning devices for removal efficiency
ISO 29463: High-efficiency filters and filter media for removing particles in air (HEPA/ULPA)
EN 1822: European standard for HEPA/ULPA filters
IEST-RP-CC001: HEPA and ULPA filters – definitions, leak tests
IEST-RP-CC006: Testing cleanrooms
IEST-RP-CC007: Testing ULPA filters
IEST-RP-CC002: Unidirectional flow clean-air devices

Decontamination & Disinfection

EN 17141: Biocontamination control for cleanrooms
NSF/ANSI 49 (again, covers BSC decon requirements using formaldehyde or alternative agents)
EPA & Health Canada Pesticide Regulations (for approval of disinfectants used in decon)
ISO 15883: Washer-disinfectors (healthcare reprocessing)

Healthcare-Specific Standards & Guidelines

CSA Z8000: Canadian health care facilities – design and construction (ventilation, isolation rooms)
CAN/CSA-Z317.2: Special requirements for HVAC systems in healthcare facilities
CDC Guidelines for Environmental Infection Control in Healthcare Facilities
NIOSH guidelines: For hazard containment and airflow

Other Guidance & Best Practices

WHO GMP for Sterile Pharmaceutical Products
ISPE Baseline Guides (Cleanrooms, HVAC, etc.)
CETA CAGs (Controlled Environment Testing Association’s Application Guides)