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ep-2631-limulus-amebocyte-lysate-test-for-endotoxins
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 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 EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins Laboratory Testing Service Provided by Eurolab

The EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins is a widely recognized and accepted standard for detecting endotoxin contamination in pharmaceuticals, medical devices, and other products. This test is based on the principles of the limulus amebocyte lysate (LAL) assay, which uses the extract from the horseshoe crab to detect the presence of endotoxins.

Relevant Standards

  • ISO 11133:2014 - Microbiology of food and animal feeding stuffs - Guidance on testing of chemical preservatives

  • ASTM E2187-13 - Standard Practice for Determining the Limulus Amebocyte Lysate (LAL) Reactive Endotoxin in Reagents

    • Legal and Regulatory Framework

    The regulation of endotoxins is governed by various international and national standards, including:

  • FDA 21 CFR Part 211.110(b) - Control of Contaminants

  • EU GMP Annex 1: Manufacture of Sterile Products

  • ISO 11133:2014

    • International and National Standards

    The standard for EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins is governed by the following international and national standards:

  • ISO/TS 11133-1:2007 - Microbiology of food and animal feeding stuffs - Guidance on testing of chemical preservatives

  • ASTM E2187-13

    • Standard Development Organizations

    The development of standards for endotoxin detection is carried out by various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • Evolution of Standards

    Standards evolve over time to reflect new technologies and methodologies. The standard for EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins has undergone revisions to ensure that it remains relevant and effective.

    Standard Numbers and Scope

    The following standard numbers and scopes are relevant to the EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins:

  • ISO 11133:2014 - Microbiology of food and animal feeding stuffs - Guidance on testing of chemical preservatives

  • ASTM E2187-13 - Standard Practice for Determining the Limulus Amebocyte Lysate (LAL) Reactive Endotoxin in Reagents

    • Standard Compliance Requirements

    Compliance with standards is mandatory for industries that handle pharmaceuticals, medical devices, and other products that require endotoxin detection. Failure to comply can result in product recalls, fines, and reputational damage.

    Standards-Related Costs

    The cost of compliance with standards varies depending on the industry and the type of product being tested. However, the benefits of compliance far outweigh the costs.

    Standard Compliance Requirements for Different Industries

    Different industries have varying standard compliance requirements for endotoxin detection:

  • Pharmaceuticals: Comply with FDA 21 CFR Part 211.110(b) - Control of Contaminants

  • Medical Devices: Comply with EU GMP Annex 1: Manufacture of Sterile Products

    • Why EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins is Required

    The EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins is required because it provides a reliable and accurate method of detecting endotoxin contamination in products.

    Business and Technical Reasons for Conducting the Test

    Conducting the EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins is necessary to ensure product safety, reliability, and compliance with regulatory requirements.

    Consequences of Not Performing the Test

    Failure to perform the test can result in:

  • Product recalls

  • Fines and penalties

  • Reputational damage

    • Industries that Require this Testing

    The following industries require endotoxin detection testing:

  • Pharmaceuticals

  • Medical Devices

  • Biotechnology

    • Risk Factors and Safety Implications

    Endotoxins can cause serious health problems, including septic shock and death.

    Quality Assurance and Quality Control Aspects

    Quality assurance and quality control measures are essential to ensure the accuracy and reliability of endotoxin detection testing.

    Contribution to Product Safety and Reliability

    The EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins contributes significantly to product safety and reliability by detecting endotoxin contamination.

    Benefits of Compliance with Standards

    Compliance with standards provides numerous benefits, including:

  • Increased customer satisfaction

  • Reduced costs associated with product recalls

  • Improved reputation

    • Why Choose Eurolab for EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins?

    Eurolab is a leading provider of laboratory testing services, including the EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins.

    Conclusion

    The EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins is a widely recognized and accepted standard for detecting endotoxin contamination in products. Compliance with standards is mandatory for industries that handle pharmaceuticals, medical devices, and other products that require endotoxin detection.

    Standards-Related References

  • ISO 11133:2014 - Microbiology of food and animal feeding stuffs - Guidance on testing of chemical preservatives

  • ASTM E2187-13 - Standard Practice for Determining the Limulus Amebocyte Lysate (LAL) Reactive Endotoxin in Reagents

    • Contact Us

    For more information about our EP 2.6.31 Limulus Amebocyte Lysate Test for Endotoxins services, please contact us at insert contact information.

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