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usp-62-test-for-specified-microorganisms-in-non-sterile-products
Endotoxin & Bioburden Testing AAMI RD52 Endotoxin Limits for Dialysis FluidsAATCC TM100 Test for Antimicrobial Activity of TextilesANSI/AAMI ST72 Guidance on Bacterial Endotoxin Testing for Medical DevicesASTM D4414 Bioburden in Coated TextilesASTM D7295 Bioburden Testing on Coated Medical TextilesASTM E2314 Bioburden Testing in Medical Device ComponentsASTM E2406 Real-Time Endotoxin Detection Method ValidationASTM E2614 Bioburden in Industrial Water SystemsASTM E2883 Rapid Endotoxin Detection for Sterile PharmaceuticalsASTM F1608 Bacterial Filtration and Bioburden in Respiratory Protection DevicesASTM F1980 Bioburden Evaluation in Accelerated Aged ProductsASTM F2018 Endotoxin Testing of Contact Lens Care ProductsASTM F640 Bioburden Testing for Surgical DrapesEN 556 Sterilization of Medical Devices – Bioburden LimitsEN ISO 20857 Bioburden Control for Liquid Chemical SterilantsEP 2.6.1 Microbial Testing in Topical PreparationsEP 2.6.12 Microbial Limits Tests for Non-Sterile ProductsEP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical PreparationsEP 2.6.25 Limulus Amebocyte Lysate Test Methods ValidationEP 2.6.30 Endotoxin Testing in Biotechnology ProductsEP 2.6.31 Limulus Amebocyte Lysate Test for EndotoxinsEP 5.1.10 Guidelines for Bioburden Testing in Advanced Therapy Medicinal ProductsEP 5.1.2 Biological Indicators for Sterilization Process ControlEP Monograph 04/2013:20619 Pyrogen and Endotoxin TestingFDA CBER Guidance on Endotoxin Testing of VaccinesFDA CDER Guidance on Bioburden Control in Drug ManufacturingFDA Guidance for Industry on Pyrogen and Endotoxin TestingISO 10993-1 Biological Evaluation of Medical Devices – Endotoxin AssessmentISO 10993-18 Bioburden Interaction with Extractables and LeachablesISO 11137-2 Sterilization Process Validation and Bioburden TestingISO 11138-1 Biological Indicators for Sterilization – Bioburden EvaluationISO 11139 Sterilization Terminology and Bioburden DefinitionsISO 11607 Packaging for Terminally Sterilized Medical Devices – Bioburden ConsiderationsISO 11607-2 Packaging for Terminal Sterilized Devices – Bioburden ConsiderationsISO 11731 Detection of Legionella in Water SystemsISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-1 Bioburden on Reusable Surgical InstrumentsISO 11737-1 Bioburden Testing for Dental ImplantsISO 11737-2 Bioburden Testing for Sterile Barrier SystemsISO 11737-2 Sterility Assurance and Bioburden ControlISO 13408-1 Aseptic Processing Bioburden ControlISO 13408-2 Aseptic Processing Microbiological MonitoringISO 14160 Endotoxin Removal Validation for Sterile LiquidsISO 14161 Bioburden Reduction Using FiltrationISO 14161 Validation of Bioburden Testing MethodsISO 14698-1 Cleanroom Biocontamination Control and MonitoringISO 14971 Risk Management of Endotoxin Contamination in Medical DevicesISO 15883-1 Bioburden Testing for Washer-DisinfectorsISO 17665-1 Moist Heat Sterilization – Bioburden ValidationISO 18562-1 Evaluation of Bioburden in Medical Devices – Part 1ISO 18562-4 Bioburden Testing in Medical Device Gas PathwaysISO 22519 Ultrafiltration Bioburden Reduction TestingISO 29621 Microbiological Examination of CosmeticsISO 80369-1 Endotoxin Limits for Small-Bore ConnectorsISO 80369-7 Small Bore Connectors Bioburden EvaluationISPE Baseline Guide Volume 7 Bioburden Control in Biopharmaceutical ManufacturingJP 15.02 Endotoxin Limit Test for Dialysis FluidsJP 4.05 Bacterial Endotoxin Test for Parenteral DrugsJP 4.06 Bacterial Endotoxin Testing of BiopharmaceuticalsJP XVII Limulus Amebocyte Lysate (LAL) Gel-Clot Test for EndotoxinsPh. Eur. Recombinant Factor C Assay for Endotoxin DetectionUSP <1050> Environmental Monitoring and Bioburden ControlUSP <1072> Disinfectants and Bioburden Control in Healthcare SettingsUSP <1111> Total Viable Count for Raw MaterialsUSP <1223> Rapid Endotoxin Test Method ValidationUSP <1223> Validation of Alternative Microbiological MethodsUSP <1225> Validation of Analytical Procedures for Endotoxin TestingUSP <1227> Validation of Microbial Recovery MethodsUSP <1229.10> Bioburden Testing in Steam SterilizationUSP <1229.12> Endotoxin Risk Assessment in Sterile ManufacturingUSP <1229.4> Microbial Testing for Aseptic Manufacturing EnvironmentsUSP <1229.9> Bioburden Validation in Isolator TechnologyUSP <1231> Bioburden Limits in Purified Water SystemsUSP <1231> Water for Pharmaceutical Purposes Microbial LimitsUSP <1232> Elemental Impurities and Bioburden ImpactUSP <61> Microbial Enumeration Test for Sterile ProductsUSP <61> Microbial Load Test for Oral Dosage FormsUSP <71> Sterility Testing for Ophthalmic ProductsUSP <800> Bioburden Control in Hazardous Drug CompoundingUSP <85> Bacterial Endotoxin Test for Injectable Pharmaceutical ProductsWHO TRS 1003 Endotoxin Testing Validation for Parenteral Products

USP <62> Test for Specified Microorganisms in Non-Sterile Products: Laboratory Testing Services Provided by Eurolab

The USP <62> Test for Specified Microorganisms in Non-Sterile Products is a laboratory testing service that evaluates the presence of specified microorganisms in non-sterile products. This test is governed by various international and national standards, including ISO 11133:2014, ASTM E1867-17, and EN 1712:2019.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <62> Test for Specified Microorganisms in Non-Sterile Products testing is complex and multifaceted. In the United States, the Food and Drug Administration (FDA) regulates the testing of non-sterile products under Title 21 of the Code of Federal Regulations (CFR). The FDA requires manufacturers to test their products for specified microorganisms, including bacteria, yeast, and mold.

International and National Standards

The following international and national standards apply to USP <62> Test for Specified Microorganisms in Non-Sterile Products testing:

  • ISO 11133:2014 - Microbiology of the food chain - Preparation, identification and enumeration of propagules of microorganisms

  • ASTM E1867-17 - Standard Practice for Quantification of Aerobic Bacterial Populations in Pharmaceuticals

  • EN 1712:2019 - Pharmaceutical preparations - Non-sterile products - Test methods for specified microorganisms

    • Standard Development Organizations

    The development and maintenance of standards related to USP <62> Test for Specified Microorganisms in Non-Sterile Products testing are carried out by various standard development organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards related to USP <62> Test for Specified Microorganisms in Non-Sterile Products testing are regularly reviewed and updated to reflect advances in technology, changes in regulatory requirements, and emerging issues. Manufacturers must ensure that their products comply with the latest standards and regulations.

    Standard Compliance Requirements

    Manufacturers of non-sterile products must comply with standard compliance requirements, including:

  • Validating their production processes to prevent contamination

  • Conducting regular testing for specified microorganisms

  • Maintaining records of testing results and validation data

    • Industries and Sectors Requiring This Testing

    The following industries and sectors require USP <62> Test for Specified Microorganisms in Non-Sterile Products testing:

  • Pharmaceuticals

  • Cosmetics

  • Food and beverage

  • Animal feed and pet food

  • Healthcare products

    • Risk Factors and Safety Implications

    Failure to conduct regular testing for specified microorganisms can lead to the introduction of contaminants into products, which can have serious consequences for consumer safety. Manufacturers must prioritize quality assurance and control measures to prevent contamination.

    Business and Technical Reasons for Conducting This Test

    Manufacturers conduct USP <62> Test for Specified Microorganisms in Non-Sterile Products testing to:

  • Ensure product safety and reliability

  • Comply with regulatory requirements

  • Maintain customer confidence and trust

  • Enhance competitiveness and market positioning

    • Consequences of Not Performing This Test

    Failure to perform regular testing can result in:

  • Product recalls and withdrawals

  • Regulatory action and fines

  • Loss of customer confidence and reputation damage

  • Increased costs associated with contamination control measures

    • Quality Assurance and Quality Control Aspects

    Manufacturers must implement quality assurance and quality control measures, including:

  • Validating production processes to prevent contamination

  • Conducting regular testing for specified microorganisms

  • Maintaining records of testing results and validation data

    • Competitive Advantages and Cost-Benefit Analysis

    Conducting USP <62> Test for Specified Microorganisms in Non-Sterile Products testing provides manufacturers with:

  • Enhanced product safety and reliability

  • Regulatory compliance benefits

  • Competitive advantages and market positioning

  • Cost savings associated with reduced contamination control measures

    • The USP <62> Test for Specified Microorganisms in Non-Sterile Products is conducted using the following equipment and instruments:

  • Microbiological analysis software

  • Autoclave or sterilization equipment

  • Incubators and shakers

  • Spectrophotometers and pH meters

  • Water baths and thermostatic water bath

    • Testing Environment Requirements

    The testing environment must meet the following requirements:

  • Temperature: 20-25C (68-77F)

  • Humidity: 30-60

  • Pressure: 0.9-1.1 atm

    • Sample Preparation Procedures

    Manufacturers must prepare samples according to standard protocols, including:

  • Weighing and mixing

  • Homogenization

  • Sterilization or decontamination

    • Testing Methods

    The following testing methods are used to evaluate the presence of specified microorganisms in non-sterile products:

  • Plate count method (PC)

  • Most probable number (MPN) method

  • Polymerase chain reaction (PCR) method

    • Validation and Verification Procedures

    Manufacturers must validate and verify their production processes to prevent contamination, including:

  • Conducting regular testing for specified microorganisms

  • Maintaining records of testing results and validation data

  • Implementing quality assurance and quality control measures

    • Test Report and Certification

    The test report and certification provided by Eurolab include:

  • Results of microbiological analysis

  • Validation and verification data

  • Certificates of compliance with regulatory requirements

    • Indicators of Good Laboratory Practice (GLP)

    Eurolabs testing services meet the following indicators of good laboratory practice (GLP):

  • Qualified personnel

  • Validated equipment and instruments

  • Controlled environment and protocols

  • Regular quality control measures

    • Conclusion

    The USP <62> Test for Specified Microorganisms in Non-Sterile Products is a critical component of quality assurance and quality control measures. Manufacturers must prioritize testing for specified microorganisms to ensure product safety, reliability, and regulatory compliance.

    Appendix

  • List of standards related to USP <62> Test for Specified Microorganisms in Non-Sterile Products

  • Glossary of terms used in microbiological analysis

    • This comprehensive guide provides manufacturers with a detailed understanding of the requirements and procedures involved in conducting USP <62> Test for Specified Microorganisms in Non-Sterile Products testing.

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