EUROLAB
who-trs-1003-endotoxin-testing-validation-for-parenteral-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 CompoundingUSP <85> Bacterial Endotoxin Test for Injectable Pharmaceutical Products

WHO TRS 1003 Endotoxin Testing Validation for Parenteral Products: Eurolabs Laboratory Testing Service

The World Health Organization (WHO) Technical Report Series (TRS) No. 1003, Endotoxins - Guidelines on the validation of endotoxin testing, provides a framework for the validation and testing of endotoxins in parenteral products. The standards governing this testing service include:

1. ISO 11133:2014, Microbiology of food, water and animal feeding stuffs Preparation, enrichment, isolation, identification and differentation of potential pathogens.

2. ASTM E2187-13, Standard Practice for Determining the Endotoxin Content of Pharmaceuticals.

3. EN ISO 11133:2009, Microbiologie des aliments, de leau et des produits dalimentation animale Préparation, enrichissement, isolation, identification et différenciation des agents pathogènes potentiels.

4. TSE (Turkish Standards Institution) EN ISO 11133:2009, Microbiologie des aliments, de leau et des produits dalimentation animale Préparation, enrichissement, isolation, identification et différenciation des agents pathogènes potentiels.

5. USP <85>, Bacterial Endotoxins Test.

These standards are published and maintained by standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), Turkish Standards Institution (TSE), and United States Pharmacopeia (USP).

The legal and regulatory framework surrounding WHO TRS 1003 Endotoxin Testing Validation for Parenteral Products testing is governed by national and international regulations, including:

  • US FDA 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.

  • EU GMP (Good Manufacturing Practice) Regulation (EC) No. 2004/227/EC.

  • Japanese Ministry of Health, Labour and Welfares Pharmaceutical Affairs Bureau guidelines.

    • These regulations require parenteral products to be tested for endotoxins to ensure product safety and reliability.

    The WHO TRS 1003 Endotoxin Testing Validation for Parenteral Products testing is required to:

    1. Ensure product safety: Endotoxins can cause pyrogenic reactions, which can lead to serious health consequences.

    2. Meet regulatory requirements: Compliance with national and international regulations requires regular endotoxin testing.

    3. Maintain product quality: Endotoxin testing ensures that products meet the required standards for purity and potency.

    The consequences of not performing this test are:

  • Product recalls due to contamination

  • Delayed or halted production

  • Loss of customer trust and reputation

    • Industries and sectors that require WHO TRS 1003 Endotoxin Testing Validation for Parenteral Products testing include:

    1. Pharmaceutical manufacturers: To ensure product safety and reliability.

    2. Biotechnology companies: To maintain product quality and meet regulatory requirements.

    3. Medical device manufacturers: To ensure the safety of medical devices.

    The risk factors and safety implications associated with endotoxins are:

  • Pyrogenic reactions

  • Systemic inflammation

  • Anaphylaxis

    • Quality assurance and quality control aspects include:

    1. Validation of testing procedures

    2. Calibration and maintenance of equipment

    3. Training of personnel

    This test contributes to product safety and reliability by:

    1. Ensuring endotoxin levels are within acceptable limits

    2. Preventing contamination and pyrogenic reactions

    The competitive advantages of having this testing performed include:

  • Increased customer trust and loyalty

  • Improved product quality and reliability

  • Compliance with national and international regulations

    • The cost-benefit analysis of performing this test shows that the benefits far outweigh the costs.

    WHO TRS 1003 Endotoxin Testing Validation for Parenteral Products testing involves:

    1. Sample preparation: Preparation of samples according to standard procedures.

    2. Testing equipment: Use of validated equipment, such as the LAL (Limulus Amebocyte Lysate) test kit.

    3. Testing environment: Maintenance of a controlled environment, including temperature, humidity, and pressure.

    4. Measurement and analysis methods: Use of standardized measurement and analysis techniques.

    The testing parameters and conditions include:

    1. Sample size: Determination of the required sample size based on statistical considerations.

    2. Endotoxin concentration: Measurement of endotoxin levels using validated equipment.

    3. Testing frequency: Regular testing to ensure ongoing product safety.

    Measurement and Analysis Methods

    WHO TRS 1003 Endotoxin Testing Validation for Parenteral Products testing involves:

    1. LAL (Limulus Amebocyte Lysate) test: Use of the LAL test kit to measure endotoxin levels.

    2. Standardized measurement techniques: Use of validated equipment and standardized procedures.

    Conclusion

    WHO TRS 1003 Endotoxin Testing Validation for Parenteral Products is a critical testing service required to ensure product safety, quality, and reliability. Eurolabs laboratory testing service provides accurate and reliable results, ensuring compliance with national and international regulations.

    Next Steps

    If you are interested in learning more about WHO TRS 1003 Endotoxin Testing Validation for Parenteral Products or would like to schedule a testing service, please contact us at insert contact information.

    We provide expert analysis and reporting of test results, ensuring that your products meet the required standards for purity and potency.

    References

    1. WHO Technical Report Series No. 1003, Endotoxins - Guidelines on the validation of endotoxin testing.

    2. ISO 11133:2014, Microbiology of food, water and animal feeding stuffs Preparation, enrichment, isolation, identification and differentation of potential pathogens.

    3. ASTM E2187-13, Standard Practice for Determining the Endotoxin Content of Pharmaceuticals.

    Please note that this is a sample text and you should adjust it according to your specific needs and requirements.

    Also, please let me know if you want me to make any changes or if you are satisfied with the content.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers