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usp-85-bacterial-endotoxin-test-for-injectable-pharmaceutical-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 2.6.30 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 CompoundingWHO TRS 1003 Endotoxin Testing Validation for Parenteral Products

USP <85> Bacterial Endotoxin Test for Injectable Pharmaceutical Products: Laboratory Testing Services

Standard-Related Information

The USP <85> Bacterial Endotoxins Test is a laboratory testing service that measures the presence of bacterial endotoxins in injectable pharmaceutical products. This test is governed by various international and national standards, including:

  • ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for irritation

  • ASTM E1177-16 Standard Test Method for Determining Bacterial Endotoxin in Reagents Used in the Assay of Endotoxins

  • EN ISO 11133:2014 Microbiology of food, animal feeding stuffs and pharmaceutical products Guidelines on preparation and production of culture media

    • The legal and regulatory framework surrounding this testing service includes:

  • USP <85> Bacterial Endotoxins Test: This standard outlines the requirements for testing injectable pharmaceutical products for bacterial endotoxins.

  • FDA Guidance for Industry: Control of Endogenous Pyrogens in Monoclonal Antibody Products

  • ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Pharmaceutical Substances

    • International and national standards that apply to this specific laboratory test include:

  • ISO 9001:2015 Quality Management System Requirements

  • ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories

  • FDA Good Laboratory Practice (GLP) regulations

    • Standard development organizations, such as the International Organization for Standardization (ISO), play a crucial role in developing and updating standards.

    Standard Requirements and Needs

    The USP <85> Bacterial Endotoxin Test is required to ensure product safety and reliability. This test is essential for:

  • Ensuring product sterility

  • Detecting bacterial endotoxins that can cause pyrogenic reactions

  • Compliance with regulatory requirements

  • Maintaining product quality and consistency

    • Consequences of not performing this test include:

  • Product contamination and recalls

  • Safety risks to patients and consumers

  • Regulatory non-compliance and fines

    • Industries and sectors that require this testing include:

  • Pharmaceuticals

  • Biotechnology

  • Medical devices

  • Cosmetics

  • Food and beverages

    • Risk factors and safety implications of bacterial endotoxins include:

  • Pyrogenic reactions

  • Anaphylaxis

  • Inflammation

  • Bacterial contamination

    • This test contributes to product safety and reliability by ensuring the absence of bacterial endotoxins.

    Test Conditions and Methodology

    The USP <85> Bacterial Endotoxin Test is conducted using the following equipment and instruments:

  • PyroGene LAL reagent

  • Chromogenic substrate (e.g., limulus amebocyte lysate)

  • Spectrophotometer

    • Testing environment requirements include:

  • Temperature: 20-25C

  • Humidity: 40-60

  • Pressure: atmospheric pressure

    • Sample preparation procedures involve diluting the sample with a suitable buffer and adding the pyroGene reagent.

    The testing parameters and conditions are as follows:

  • Incubation time: 30 minutes to 1 hour

  • Temperature: 37C 2C

  • pH: 7.0-8.5

    • Measurement and analysis methods involve spectrophotometric detection of endotoxin activity.

    Calibration and validation procedures include:

  • Calibration of equipment and instruments

  • Validation of testing parameters and conditions

  • Quality control measures during testing

    • Quality control measures during testing include:

  • Positive controls (endotoxin standards)

  • Negative controls (endotoxin-free samples)

  • Statistical analysis of test results

    • Data collection and recording procedures involve documenting all testing activities, including sample preparation, testing parameters, and measurement results.

    Test Reporting and Documentation

    The USP <85> Bacterial Endotoxin Test report includes:

  • Sample identification

  • Testing date and time

  • Test conditions (temperature, pH, etc.)

  • Measurement results

  • Conclusion

    • Certification and accreditation aspects include:

  • ISO 17025 certification for testing laboratories

  • EU GMP certification for pharmaceutical manufacturers

    • Reporting standards and formats include:

  • PDF reports

  • Electronic reporting systems (e.g., Eurolabs online platform)

    • Results validation and verification involve:

  • Statistical analysis of test results

  • Verification of measurement results against reference values

    • Electronic reporting systems used by Eurolab include:

  • Online platforms for result submission and review

  • Automated report generation and notification

    • Why This Test Should Be Performed

    Performing the USP <85> Bacterial Endotoxin Test offers numerous benefits, including:

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance with regulatory requirements

  • Competitive advantages in the market

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

    • Why Eurolab Should Provide This Service

    Eurolabs laboratory testing services for injectable pharmaceutical products include:

  • Bacterial endotoxin testing (USP <85>)

  • Sterility testing (ISO 11133)

  • Pyrogenic tests (ASTM E1177)

    • Our state-of-the-art facilities and experienced staff ensure accurate and reliable test results.

    Conclusion

    The USP <85> Bacterial Endotoxin Test is a crucial laboratory testing service for ensuring product safety and reliability in injectable pharmaceutical products. Eurolabs comprehensive guide to this testing service provides valuable insights into standard-related information, standard requirements and needs, test conditions and methodology, and test reporting and documentation. By performing this test, manufacturers can ensure compliance with regulatory requirements, maintain product quality, and reduce the risk of pyrogenic reactions and bacterial contamination.

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