Lewis Testing Services, Inc.   

 
 

 

Appropriate Industry Specifications/Documents


  • 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

  • IEST - Institute of Environmental Sciences and Technology
    • IEST-RP-CC001: HEPA AND ULPA FILTERS
    • IEST-RP-CC002: UNIDIRECTIONAL-FLOW CLEAN-AIR DEVICES
    • IEST-RP-CC006: TESTING CLEANROOMS
    • IEST-RP-CC013: CALIBRATION PROCEDURES AND GUIDELINES FOR SELECT EQUIPMENT USED IN TESTING CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS
    • IEST-RP-CC034: HEPA AND ULPA FILTER LEAK TESTS

  • USP - United States Pharmacopeia
    • General Chapter <797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS
    • General Chapter <800> HAZARDOUS DRUGS-HANDLING IN HEALTHCARE SETTINGS
    • 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
    • Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (July 2014)
    • 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-005: 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

  • Others
    • NSF/ANSI 49: Biosafety Cabinetry: Design, Construction, Performance, and Field Certification
    • SEFA - Scientific Equipment & Furniture Association Recommended Practices For Laboratory Fume Hoods
    • 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