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ep-2614-bacterial-endotoxins-test-for-pharmaceutical-preparations
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 2.6.25 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

EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations: Laboratory Testing Services

Standard-Related Information

The EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations is a critical laboratory testing service that ensures the safety and quality of pharmaceutical products. This test is governed by various international and national standards, including:

  • ISO 19005:2011: Guidelines on the application of ISO 11133 (Microbiology)

  • ASTM E2557-15: Standard Practice for Determination of Endotoxins in Reagents Used in Cellular Studies

  • EN 1519-4:2015: Bacterial endotoxin test - Part 4: Pyrogen-free water

  • TSE (Turkish Standards Institution): TS EN ISO 19005:2011

  • USP <85>: Bacterial Endotoxins Test

    • These standards specify the requirements for the testing of bacterial endotoxins in pharmaceutical products, including the methodology, equipment, and quality control procedures.

    Legal and Regulatory Framework

    The EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations is subject to various laws and regulations, including:

  • Good Manufacturing Practice (GMP): Ensures that pharmaceutical products are manufactured in a controlled environment

  • International Organization for Standardization (ISO) standards: Provides guidelines for quality management systems and testing procedures

  • USP <85>: Bacterial Endotoxins Test is a regulatory requirement for pharmaceutical products

    • Standard Development Organizations

    The development of standards for the EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations involves various organizations, including:

  • International Organization for Standardization (ISO): Develops and publishes international standards

  • American Society for Testing and Materials (ASTM): Develops and publishes standards for testing and materials science

  • European Committee for Standardization (CEN): Develops and publishes European standards

    • Standard Evolution and Updates

    Standards for the EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations are regularly reviewed and updated to reflect advances in technology, new research findings, and changing regulatory requirements.

    Specific Standard Numbers and Scope

    The following standard numbers and scopes apply to the EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations:

  • ISO 19005:2011: Guidelines on the application of ISO 11133 (Microbiology)

  • ASTM E2557-15: Standard Practice for Determination of Endotoxins in Reagents Used in Cellular Studies

  • EN 1519-4:2015: Bacterial endotoxin test - Part 4: Pyrogen-free water

    • Standard Compliance Requirements

    Compliance with standards is a critical aspect of the EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations. Manufacturers must ensure that their products meet the requirements specified in the relevant standards.

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    Standard Requirements and Needs

    The EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations is required to ensure the safety and quality of pharmaceutical products. This test detects the presence of bacterial endotoxins, which can cause pyrogenic reactions in humans.

    Business and Technical Reasons for Conducting Testing

    Conducting the EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations is essential for several reasons:

  • Ensures product safety: Detects potential hazards that could lead to adverse reactions

  • Compliance with regulations: Meets regulatory requirements and standards

  • Quality control: Ensures the quality of pharmaceutical products

    • Consequences of Not Performing Testing

    Failing to conduct the EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations can have severe consequences, including:

  • Adverse reactions: Pyrogenic reactions in humans

  • Product recalls: Manufacturers may be required to recall products that fail to meet standards

  • Regulatory non-compliance: Manufacturers may face regulatory action and fines

    • Industries and Sectors Requiring Testing

    The EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations is essential for various industries, including:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Medical device manufacturers

    • ---

    Test Conditions and Methodology

    The EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations involves several steps, including:

    1. Sample preparation: Preparation of the test sample

    2. Testing equipment and instruments: Use of specific equipment and instruments to detect bacterial endotoxins

    3. Quality control procedures: Ensures that the testing process is accurate and reliable

    Testing Equipment and Instruments

    The following equipment and instruments are used for the EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations:

  • LAL (Limulus amebocyte lysate) test kit

  • Pyrogen-free water

  • Endotoxin detection system

    • Quality Control Procedures

    Quality control procedures are essential to ensure that the EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations is accurate and reliable.

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    Interpretation of Results

    The results of the EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations must be interpreted correctly to ensure that products meet regulatory requirements.

  • Negative result: Product meets standards

  • Positive result: Product does not meet standards

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    EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations: Conclusion

    The EP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical Preparations is a critical laboratory testing service that ensures the safety and quality of pharmaceutical products. Manufacturers must comply with regulatory requirements, use standard-compliant equipment and instruments, and follow quality control procedures to ensure accurate results.

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    Recommendation

    We recommend that manufacturers conduct regular audits and assessments to ensure compliance with standards and regulations. Regular training for personnel is also essential to ensure that they are aware of the latest testing methods and procedures.

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