{"id":72,"date":"2020-11-09T23:18:58","date_gmt":"2020-11-09T23:18:58","guid":{"rendered":"http:\/\/lewistestingservices.com\/?page_id=72"},"modified":"2021-04-21T20:35:04","modified_gmt":"2021-04-21T20:35:04","slug":"specifications-documents","status":"publish","type":"page","link":"https:\/\/lewistestingservices.com\/index.php\/specifications-documents\/","title":{"rendered":"Specifications \/ Documents"},"content":{"rendered":"\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t
\n\t\t\t\n\t\n\t\n\t\n<\/svg>\t\t<\/div>\n\t\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t

Appropriate Industry Specifications \/ Documents<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

ISO – International Organization for Standardization<\/strong><\/p>\n

    \n
  • ISO 14644-1 Classification of Air Cleanliness<\/li>\n
  • ISO 14644-2 Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1<\/li>\n
  • ISO 14644-3 Test Methods<\/li>\n
  • ISO 14644-4 Design, Construction and Start-up<\/li>\n
  • ISO 14644-5 Operations<\/li>\n
  • ISO 14644-7 Separative Devices (clean air hoods, gloveboxes, isolators and mini-environments<\/li>\n
  • ISO 14698-1 Biocontamination Control General Principles and Methods<\/li>\n<\/ul>\n

    IEST – Institute of Environmental Sciences and Technology<\/strong><\/p>\n

      \n
    • IEST-RP-CC001: HEPA AND ULPA FILTERS<\/li>\n
    • IEST-RP-CC002: UNIDIRECTIONAL-FLOW CLEAN-AIR DEVICES<\/li>\n
    • IEST-RP-CC003: GARMENT SYSTEM CONSIDERATIONS FOR CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS<\/li>\n
    • IEST-RP-CC006: TESTING CLEANROOMS<\/li>\n
    • IEST-RP-CC007: TESTING ULPA FILTERS<\/li>\n
    • IEST-RP-CC012: CONSIDERATIONS IN CLEANROOM DESIGN<\/li>\n
    • IEST-RP-CC013: CALIBRATION PROCEDURES AND GUIDELINES FOR SELECT EQUIPMENT USED IN TESTING CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS<\/li>\n
    • IEST-RP-CC018: CLEANROOM HOUSEKEEPING: OPERATING AND MONITORING PROCEDURES<\/li>\n
    • IEST-RP-CC019: QUALIFICATIONS FOR ORGANIZATIONS ENGAGED IN THE TESTING AND CERTIFICATION OF CLEANROOMS AND CLEAN-AIR DEVICES<\/li>\n
    • IEST-RP-CC023: MICROORGANISMS IN CLEANROOMS<\/li>\n
    • IEST-RP-CC026: CLEANROOM OPERATIONS<\/li>\n
    • IEST-RP-CC027: PERSONNEL PRACTICES AND PROCEDURES IN CLEANROOMS AND CONTROLLED ENVIRONMENTS<\/li>\n
    • IEST-RP-CC034: HEPA AND ULPA FILTER LEAK TESTS<\/li>\n
    • IEST-RD-CC011: A GLOSSARY OF TERMS AND DEFINITIONS RELATING TO CONTAMINATION CONTROL<\/li>\n
    • IEST-G-CC1001: COUNTING AIRBORNE PARTICLES FOR CLASSIFICATION AND MONITORING OF CLEANROOMS AND CLEAN ZONES<\/li>\n<\/ul>\n

      USP – United States Pharmacopeia<\/strong><\/p>\n

        \n
      • General Chapter <797> PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS<\/li>\n
      • General Chapter <800> HAZARDOUS DRUGS-HANDLING IN HEALTHCARE SETTINGS<\/li>\n
      • General Chapter <795> PHARMACEUTICAL COMPOUNDING-NONSTERILE PREPARATIONS<\/li>\n
      • General Chapter <825> RADIOPHARMACEUTICALS-PREPARATION, COMPOUNDING, DISPENSING, AND REPACKAGING<\/li>\n
      • General Chapter <1066> PHYSICAL ENVIRONMENTS THAT PROMOTE SAFE MEDICATION USE<\/li>\n
      • General Chapter <1116> MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS<\/li>\n<\/ul>\n

        CDER – U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research<\/strong><\/p>\n

          \n
        • 503A: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (July 2014)<\/li>\n
        • 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)<\/li>\n<\/ul>\n

          CETA – Controlled Environment Testing Association CAG – CETA Applications Guides<\/strong><\/p>\n

            \n
          • CAG-001: Applications Guide For The Use Of Compounding Isolators In Compounding Sterile Preparations In Healthcare Facilities<\/li>\n
          • CAG-002: Compounding Isolator Testing Guide<\/li>\n
          • CAG-003: Sterile Compounding Facilities<\/li>\n
          • CAG-004: Biological Decontamination and Disinfection of Accessible Surfaces in Biosafety Cabinets<\/li>\n
          • CAG-005: Servicing Hazardous Drug Compounding Primary Engineering Controls<\/li>\n
          • CAG-006: High Efficiency Filter Application Guide<\/li>\n
          • CAG-007: Exhaust System Requirements of Class II Biosafety Cabinets<\/li>\n
          • CAG-008: CETA Certification Matrix for Sterile Compounding Facilities<\/li>\n
          • CAG-009: Viable Environmental Monitoring for Sterile Compounding Facilities<\/li>\n
          • CAG-010: Application Guide for Informational Notes to Meet the NSF\/ANSI 49:2010a Standard Requirements<\/li>\n<\/ul>\n

            Others<\/strong><\/p>\n

              \n
            • NSF\/ANSI 49: Biosafety Cabinetry: Design, Construction, Performance, and Field Certification<\/li>\n
            • ANSI\/AIHA Z9.5: Laboratory Ventilation<\/li>\n
            • SEFA 1: Scientific Equipment & Furniture Association Recommended Practices For Laboratory Fume Hoods<\/li>\n
            • SEFA 9: Scientific Equipment & Furniture Association Recommended Practices For Ductless Enclosures<\/li>\n
            • ASHRAE 110: Method of Testing Performance of Laboratory Fume Hoods<\/li>\n
            • NIOSH ALERT Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings<\/li>\n
            • FDA Aseptic Processing Guide<\/li>\n
            • BMBL – Biosafety in Microbiological and Biomedical Laboratories<\/li>\n<\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
              \n\t\t\t\t\t\t\t
              <\/div>\n\t\t\t\t\t\t
              \n\t\t\t\n\t\n\t\n\t\n<\/svg>\t\t<\/div>\n\t\t\t\t\t
              \n\t\t\t\t\t\t\t
              \n\t\t\t\t\t
              \n\t\t\t
              \n\t\t\t\t\t\t\t
              \n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

              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 ISO 14644-5 Operations ISO 14644-7 Separative Devices (clean air hoods, gloveboxes, isolators and mini-environments […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":[],"_links":{"self":[{"href":"https:\/\/lewistestingservices.com\/index.php\/wp-json\/wp\/v2\/pages\/72"}],"collection":[{"href":"https:\/\/lewistestingservices.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/lewistestingservices.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/lewistestingservices.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lewistestingservices.com\/index.php\/wp-json\/wp\/v2\/comments?post=72"}],"version-history":[{"count":26,"href":"https:\/\/lewistestingservices.com\/index.php\/wp-json\/wp\/v2\/pages\/72\/revisions"}],"predecessor-version":[{"id":816,"href":"https:\/\/lewistestingservices.com\/index.php\/wp-json\/wp\/v2\/pages\/72\/revisions\/816"}],"wp:attachment":[{"href":"https:\/\/lewistestingservices.com\/index.php\/wp-json\/wp\/v2\/media?parent=72"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}