EUROLAB
iso-11737-2-bioburden-testing-for-sterile-barrier-systems
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 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 <62> Test for Specified Microorganisms in Non-Sterile ProductsUSP <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

ISO 11737-2 Bioburden Testing for Sterile Barrier Systems: Laboratory Testing Services

As a leading laboratory testing service provider, Eurolab is committed to delivering high-quality results that meet the stringent requirements of ISO 11737-2 Bioburden Testing for Sterile Barrier Systems. In this comprehensive guide, we will delve into the world of bioburden testing, exploring the relevant standards, test conditions, and methodology, as well as the benefits and advantages of performing this critical test.

Standard-Related Information

ISO 11737-2 is an international standard that specifies the requirements for bioburden testing on sterilized medical devices. This standard is part of the ISO 11737 series, which provides guidelines for the determination of microbiological cleanliness of medical devices and accessories.

The legal and regulatory framework surrounding bioburden testing is governed by various national and international standards, including:

  • ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes

  • EN ISO 11737-2:2009 Microbiological tests Evaluation of the microbial cleanliness of medical devices in terms of sterility (withdrawn)

  • ASTM F1478-16 Standard Guide for Selection and Use of Methods for Determination of Bioburden on Medical Devices

    • Standard development organizations, such as the International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM), play a crucial role in ensuring that standards are up-to-date and relevant to industry needs.

    Standard Requirements and Needs

    Bioburden testing is essential for ensuring the safety and reliability of sterile medical devices. The consequences of not performing this test can be severe, including product recalls, reputational damage, and even patient harm.

    The industries and sectors that require bioburden testing include:

  • Medical device manufacturers

  • Sterilization service providers

  • Pharmaceutical companies

  • Biotechnology firms

    • The risk factors associated with bioburden testing include the potential for contamination, which can lead to product failure, recalls, or even patient harm. Quality assurance and quality control aspects are critical in ensuring that bioburden testing is performed accurately and consistently.

    Test Conditions and Methodology

    Bioburden testing involves several stages, including sample preparation, incubation, enumeration, and reporting. The test conditions and methodology used by Eurolab include:

  • Sample preparation: Sterilized samples are prepared according to the ISO 11737-2 standard

  • Incubation: Samples are incubated at a controlled temperature (typically 30C 1C) for a specified period (usually 7 days)

  • Enumeration: Microorganisms are enumerated using a standardized method, such as plate counting or ATP bioluminescence

  • Reporting: Results are reported in accordance with the ISO 11737-2 standard

    • Test Reporting and Documentation

    Eurolabs test reporting and documentation process ensures that results are accurately documented and communicated to clients. The report format and structure include:

  • Test summary: A brief overview of the test, including sample details and testing conditions

  • Results: Enumeration results, including colony-forming units (CFU) per surface area or volume

  • Conclusion: Interpretation of results in relation to the standard requirements

  • Certification: Accreditation and certification information

    • Why This Test Should Be Performed

    Bioburden testing offers several benefits and advantages, including:

  • Risk assessment and mitigation: Identifying potential contamination risks and implementing corrective actions

  • Quality assurance and compliance: Ensuring that medical devices meet regulatory requirements for sterility

  • Competitive advantages: Demonstrating a commitment to quality and safety, enhancing brand reputation and customer trust

  • Cost savings: Preventing product recalls, returns, and associated costs

  • Legal and regulatory compliance: Meeting national and international standards for bioburden testing

    • Why Eurolab Should Provide This Service

    Eurolabs expertise and experience in bioburden testing make us the ideal partner for clients seeking reliable results. Our state-of-the-art equipment and facilities, qualified and certified personnel, and accreditation details ensure that our services meet the highest standards.

    Additional advantages of choosing Eurolab include:

  • Turnaround time and efficiency: Quick turnaround times and efficient reporting processes

  • Competitive pricing and value proposition: Cost-effective solutions without compromising on quality

  • Technical support and consultation services: Expert guidance and support throughout the testing process

    • Conclusion

    Bioburden testing is a critical component of ensuring the safety and reliability of sterile medical devices. Eurolabs comprehensive guide has provided an in-depth exploration of the standard requirements, test conditions, and methodology for ISO 11737-2 Bioburden Testing for Sterile Barrier Systems.

    By choosing Eurolab as your partner for bioburden testing, you can trust that our expertise and experience will deliver high-quality results that meet the stringent requirements of international standards. Contact us today to learn more about our laboratory testing services and how we can support your needs.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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