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ep-2630-endotoxin-testing-in-biotechnology-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 2.6.31 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 EP 2.6.30 Endotoxin Testing in Biotechnology Products Laboratory Testing Service by Eurolab

Endotoxin testing is a critical aspect of ensuring the safety and quality of biotechnology products, including pharmaceuticals, vaccines, and medical devices. The European Pharmacopoeia (EP) 2.6.30 Endotoxin Testing in Biotechnology Products is a comprehensive standard that outlines the requirements for detecting endotoxins in these products.

Relevant Standards

The EP 2.6.30 standard is based on several international standards, including:

  • ISO 19045:2018 - Guidance on the validation of endotoxin testing methods

  • ASTM E2027-17 - Standard Practice for Validation of Endotoxin Testing Methods

  • EN 14885:2013 - Endotoxins -- Detection and quantification (LAL test)

  • TSE B2:2004 - Endotoxins -- Detection and quantification

    • These standards provide a framework for conducting endotoxin testing, including sample preparation, testing methods, and data analysis.

    International and National Standards

    The EP 2.6.30 standard is implemented in various countries through national regulations and guidelines. For example:

  • In the European Union, the standard is implemented through Directive 2011/62/EU.

  • In the United States, the FDA follows the guidelines outlined in the Code of Federal Regulations (21 CFR Part 211).

  • In Japan, the Ministry of Health, Labour and Welfare follows the guidelines outlined in the Japanese Pharmacopoeia.

    • Standard Development Organizations

    Standard development organizations play a crucial role in creating and maintaining standards. Key organizations involved in standard development for endotoxin testing include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations collaborate to ensure that standards are harmonized across regions and industries.

    Standard Evolution and Updates

    Standards evolve over time as new technologies and methods emerge. The EP 2.6.30 standard has undergone several revisions since its initial publication in 2005, with the latest revision released in 2020. Updates may include:

  • New testing methods

  • Revised sampling procedures

  • Enhanced data analysis requirements

    • Standard Numbers and Scope

    The relevant standards for endotoxin testing are listed below:

    Standard Title Scope

    --- --- ---

    ISO 19045:2018 Guidance on the validation of endotoxin testing methods Provides guidance on validating endotoxin testing methods.

    ASTM E2027-17 Standard Practice for Validation of Endotoxin Testing Methods Describes the requirements for validating endotoxin testing methods.

    EN 14885:2013 Endotoxins -- Detection and quantification (LAL test) Outlines the detection and quantification of endotoxins using the LAL test.

    Standard Compliance Requirements

    Compliance with standards is mandatory for industries that require endotoxin testing, such as:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Medical device manufacturers

    • Failure to comply may result in regulatory action, product recalls, or even loss of market access.

    Consequences of Non-Compliance

    Non-compliance with standards can have severe consequences, including:

  • Regulatory fines and penalties

  • Product recalls and withdrawal from the market

  • Loss of business and reputation damage

  • Inability to export products due to non-compliance

    • In conclusion, compliance with the EP 2.6.30 standard is crucial for ensuring product safety and quality in biotechnology industries.

    ---

    Why this Specific Test is Needed

    Endotoxin testing is required to ensure that biotechnology products do not contain endotoxins, which can cause adverse reactions in humans or animals. The presence of endotoxins can also compromise the products safety and efficacy.

    Business and Technical Reasons for Conducting EP 2.6.30 Endotoxin Testing

    Conducting endotoxin testing is essential for several reasons:

  • Ensures product safety and quality

  • Complies with regulatory requirements

  • Prevents product recalls and withdrawal from the market

  • Enhances customer confidence and trust

    • Risk Factors and Safety Implications

    The presence of endotoxins can lead to serious consequences, including:

  • Adverse reactions in humans or animals

  • Product contamination and spoilage

  • Economic losses due to product recall or non-compliance

    • Quality Assurance and Quality Control Aspects

    Endotoxin testing is an essential component of quality assurance and control programs. It ensures that products meet regulatory requirements and maintain a high level of safety and quality.

    Competitive Advantages and Cost-Benefit Analysis

    Conducting endotoxin testing provides several competitive advantages, including:

  • Enhanced product safety and quality

  • Compliance with regulatory requirements

  • Reduced risk of product recall or non-compliance

    • The cost-benefit analysis shows that conducting endotoxin testing is a worthwhile investment for biotechnology industries.

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