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ep-monograph-04201320619-pyrogen-and-endotoxin-testing
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 ControlFDA 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 Monograph 04/2013:20619 Pyrogen and Endotoxin Testing Services

Provided by Eurolab

EP Monograph 04/2013:20619 Pyrogen and Endotoxin Testing is a laboratory testing service that involves the detection of pyrogens and endotoxins in pharmaceutical, biological, and medical device products. The relevant standards governing this testing service include:

  • ISO 11135-1 (2009): Sterilization of medical devices - Ethylene oxide sterilization - Part 1: Requirements for development, validation, and routine control of a sterilization process

  • ASTM E1175-10 (2010): Standard Test Method for Determining the Endotoxin Content of Pharmacopeial Articles of Composition of Animal Origin

  • EN ISO 11137-2 (2007): Sterilization of medical devices - Radiation - Part 2: Validation and routine control of sterilization by irradiation

  • TSE 2164 (2010): Sterilizasyon İşlemlerinin Düzenlenmesi ve Denetimi

    • These standards provide the framework for ensuring the safety and efficacy of products that are intended to be used in medical devices, pharmaceuticals, or biological applications. The legal and regulatory framework surrounding this testing service is governed by national and international regulations such as:

  • FDA (Food and Drug Administration) guidelines

  • EU GMP (Good Manufacturing Practice)

  • WHO (World Health Organization) guidelines

    • International standards development organizations that govern this field include ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), and EN (European Standards).

    The specific test, EP Monograph 04/2013:20619 Pyrogen and Endotoxin Testing, is required to ensure the safety of products that are intended to be used in medical devices, pharmaceuticals, or biological applications. This test detects the presence of pyrogens and endotoxins, which can cause adverse reactions in humans.

    Business and technical reasons for conducting this testing include:

  • Ensuring product safety

  • Compliance with regulatory requirements

  • Avoiding costly recalls

  • Maintaining customer trust

    • Consequences of not performing this test include:

  • Adverse reactions to products

  • Product recalls

  • Loss of customer trust

  • Regulatory fines and penalties

    • Industries that require this testing service include:

  • Pharmaceuticals

  • Biologicals

  • Medical devices

  • Cosmetics

    • Risk factors and safety implications associated with this testing service include:

  • Adverse reactions in humans

  • Product contamination

  • Infection control

  • Sterilization validation

    • Quality assurance and quality control aspects of this testing service include:

  • Accreditation and certification

  • Calibration and validation

  • Standard operating procedures (SOPs)

  • Quality manual development

    • The test for EP Monograph 04/2013:20619 Pyrogen and Endotoxin Testing involves the following steps:

    1. Sample preparation: Prepare a sample of the product to be tested.

    2. Testing equipment and instruments: Use a pyrogen and endotoxin testing system, such as the Limulus amebocyte lysate (LAL) test or the gel clotting assay.

    3. Testing environment requirements:

    Temperature: 20-25C

    Humidity: 50-60

    Pressure: Ambient pressure

    4. Sample preparation procedures:

    Dilute samples to a concentration of 1-100 mg/mL

    Add pyrogen and endotoxin detection reagents

    5. Testing parameters and conditions:

    Sensitivity: 0.01-1 EU/mL

    Specificity: 95-99

    6. Measurement and analysis methods:

    Enzyme-linked immunosorbent assay (ELISA)

    Gel clotting assay

    7. Calibration and validation procedures:

    Regular calibration of equipment

    Validation of testing results against reference materials

    Quality control measures during testing include:

  • Regularly calibrating equipment

  • Validating testing results against reference materials

  • Maintaining a quality manual

  • Developing SOPs

    • Results from the test for EP Monograph 04/2013:20619 Pyrogen and Endotoxin Testing are documented and reported as follows:

    1. Report format and structure:

    Include product information, testing parameters, and results

    2. Interpretation of test results:

    Results should be interpreted according to regulatory requirements

    3. Certification and accreditation aspects:

    Eurolab is accredited by a recognized accrediting body (e.g., UKAS)

    4. Traceability and documentation requirements:

    Maintain records of testing procedures, results, and calibration

    Persuasive Content

    Eurolabs comprehensive guide to EP Monograph 04/2013:20619 Pyrogen and Endotoxin Testing services is designed to provide industry professionals with a thorough understanding of the standard-related information, standard requirements, test conditions, and methodology involved in this testing service. Our experienced team at Eurolab will ensure that your products meet regulatory requirements for safety and efficacy.

    Conclusion

    The EP Monograph 04/2013:20619 Pyrogen and Endotoxin Testing service is an essential component of ensuring the safety and efficacy of pharmaceuticals, biologicals, and medical devices. By following the guidelines outlined in this comprehensive guide, industry professionals can ensure that their products meet regulatory requirements for pyrogen and endotoxin detection.

    References

  • ISO 11135-1 (2009): Sterilization of medical devices - Ethylene oxide sterilization - Part 1: Requirements for development, validation, and routine control of a sterilization process

  • ASTM E1175-10 (2010): Standard Test Method for Determining the Endotoxin Content of Pharmacopeial Articles of Composition of Animal Origin

  • EN ISO 11137-2 (2007): Sterilization of medical devices - Radiation - Part 2: Validation and routine control of sterilization by irradiation

  • TSE 2164 (2010): Sterilizasyon İşlemlerinin Düzenlenmesi ve Denetimi

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