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astm-e2406-real-time-endotoxin-detection-method-validation
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 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 <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

Comprehensive Guide to ASTM E2406 Real-Time Endotoxin Detection Method Validation Laboratory Testing Service Provided by Eurolab

Standard-Related Information

The American Society for Testing and Materials (ASTM) has developed a standard for real-time endotoxin detection method validation, known as ASTM E2406. This standard provides guidelines for the validation of real-time endotoxin detection methods used in pharmaceutical and biotechnology industries.

Real-time endotoxin detection methods are critical in ensuring the safety and efficacy of medical devices and pharmaceutical products. Endotoxins are bacterial toxins that can cause adverse reactions, such as fever, inflammation, and even death. The presence of endotoxins can compromise product sterility and shelf-life.

The international standard ISO 11133:2014 provides guidelines for the testing of biological samples to detect microbial contamination. This standard is widely recognized globally and applies to all industries that handle biological products.

In addition to ASTM E2406, other relevant standards include:

  • ISO 11133:2014

  • EN 14694:2009

  • TSE (Turkish Standardization Institution) 101:2013

    • These standards are developed by standard development organizations such as ASTM, ISO, and national standard bodies. These organizations ensure that the standards are up-to-date with the latest scientific knowledge and regulatory requirements.

    Standard Requirements and Needs

    The need for real-time endotoxin detection method validation arises from the following business and technical reasons:

  • Ensuring product safety and efficacy

  • Compliance with regulatory requirements (e.g., USP, EP, JP)

  • Maintaining product sterility and shelf-life

  • Reducing risk of adverse reactions and recalls

  • Improving quality assurance and control

    • The consequences of not performing real-time endotoxin detection method validation include:

  • Product contamination and failure to meet regulatory requirements

  • Reduced product safety and efficacy

  • Loss of customer trust and revenue

  • Increased costs for recall, retesting, and remediation

    • The industries that require this testing include:

  • Pharmaceutical

  • Biotechnology

  • Medical device manufacturers

  • Diagnostic kit manufacturers

    • Test Conditions and Methodology

    The ASTM E2406 real-time endotoxin detection method validation test involves the following steps:

    1. Sample preparation: Prepare the biological sample according to the manufacturers instructions.

    2. Testing equipment and instruments: Use a validated real-time endotoxin detection instrument, such as a Limulus amebocyte lysate (LAL) or recombinant factor C (rFC).

    3. Testing environment requirements: Conduct testing in a temperature-controlled environment (22-25C) with relative humidity between 30-60.

    4. Measurement and analysis methods: Measure the endotoxin concentration using a validated calibration curve.

    5. Calibration and validation procedures: Validate the instrument against a certified reference material and perform regular calibration checks.

    The quality control measures during testing include:

  • Instrument maintenance and calibration

  • Sample preparation and handling

  • Testing conditions (temperature, humidity)

  • Measurement and analysis methods

    • Test Reporting and Documentation

    The test results are documented in a comprehensive report that includes:

  • Test methodology

  • Results summary

  • Statistical analysis

  • Conclusion

    • The certification and accreditation aspects include:

  • Instrument certification by the manufacturer

  • Calibration and validation records

  • Accreditation by a recognized accrediting body (e.g., ISO/IEC 17025:2017)

    • Why This Test Should Be Performed

    The benefits of performing real-time endotoxin detection method validation testing include:

  • Ensuring product safety and efficacy

  • Compliance with regulatory requirements

  • Maintaining product sterility and shelf-life

  • Reducing risk of adverse reactions and recalls

  • Improving quality assurance and control

    • Why Eurolab Should Provide This Service

    Eurolab is a leading laboratory that provides comprehensive testing services, including real-time endotoxin detection method validation. Our benefits include:

  • Expertise and experience in this field

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation by a recognized accrediting body (e.g., ISO/IEC 17025:2017)

  • Turnaround time and efficiency advantages

    • Customer Testimonials

    Eurolabs expertise and service have helped us ensure the safety and efficacy of our products. Their real-time endotoxin detection method validation testing has given us confidence in our product sterility and shelf-life. Company Name, Pharmaceutical Manufacturer

    We rely on Eurolab for all our testing needs, including real-time endotoxin detection method validation. Their service is efficient, accurate, and cost-effective. Company Name, Biotechnology Company

    Conclusion

    The ASTM E2406 real-time endotoxin detection method validation laboratory testing service provided by Eurolab ensures product safety, efficacy, and sterility. This comprehensive guide has highlighted the importance of this testing in ensuring compliance with regulatory requirements and maintaining customer trust.

    Eurolabs expertise, state-of-the-art equipment, and accredited personnel make us a leading provider of real-time endotoxin detection method validation services. Contact us today to learn more about our services and how we can help you ensure product safety and efficacy.

    References

  • ASTM E2406-14: Standard Test Method for Real-Time Endotoxin Detection Methods

  • ISO 11133:2014: Biological samples Testing for microbial contamination

  • EN 14694:2009: Medical devices Sterilization of medical devices incorporating materials requiring a low temperature process

  • TSE (Turkish Standardization Institution) 101:2013: Sterilizasyon (Sterilization)

    • Appendix

    For further information on real-time endotoxin detection method validation, please contact Eurolab at insert email and phone number.

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