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iso-14160-endotoxin-removal-validation-for-sterile-liquids
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 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 ISO 14160 Endotoxin Removal Validation for Sterile Liquids Testing Services

ISO 14160 is a widely recognized international standard that outlines the requirements for endotoxin removal validation for sterile liquids. This standard is developed and maintained by the International Organization for Standardization (ISO) in collaboration with other standard development organizations.

The legal and regulatory framework surrounding ISO 14160 testing is governed by various national and international regulations, including:

  • USP <85> (United States Pharmacopeia): Outlines requirements for endotoxin testing

  • EP 2.6.14 (European Pharmacopoeia): Defines requirements for endotoxin testing

  • JIS T 0601:2014 (Japanese Industrial Standard): Specifies requirements for endotoxin removal validation

    • ISO 14160 applies to all manufacturers of sterile liquids, including pharmaceuticals, biotechnology products, and medical devices. Compliance with this standard is mandatory for companies operating in these industries.

    Standard development organizations play a crucial role in maintaining the relevance and accuracy of ISO standards. The main players include:

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

  • American Society for Testing and Materials (ASTM): Develops and publishes standards related to materials, products, and services

  • Deutsches Institut für Normung (DIN): Develops and publishes German standards

    • Standards evolve through a continuous process of review, revision, and updating. This ensures that they remain relevant and aligned with industry needs.

    ISO 14160 Endotoxin Removal Validation for Sterile Liquids testing is essential to ensure the safety and efficacy of sterile liquids. The primary reasons for conducting this test include:

    1. Product Safety: Endotoxins can cause pyrogenic reactions, which can lead to serious health issues or even fatalities.

    2. Regulatory Compliance: Manufacturers must comply with national and international regulations, including USP <85>, EP 2.6.14, and JIS T 0601:2014.

    3. Quality Assurance: ISO 14160 ensures that manufacturers implement effective endotoxin removal validation procedures.

    Failure to conduct this test can result in:

  • Regulatory fines and penalties

  • Product recalls or withdrawals from the market

  • Loss of customer confidence and reputation damage

    • The industries and sectors that require ISO 14160 testing include:

    1. Pharmaceuticals: Manufacturers must ensure their products meet strict quality and safety standards.

    2. Biotechnology: Companies developing biopharmaceuticals, vaccines, and other biological products need to comply with ISO 14160.

    3. Medical Devices: Device manufacturers must validate the endotoxin removal process to prevent contamination.

    Risk factors and safety implications associated with non-compliance include:

    1. Pyrogenic reactions: Endotoxins can cause fever, shock, and even death in patients.

    2. Product contamination: Failure to remove endotoxins can lead to product recalls or withdrawals from the market.

    Quality assurance and quality control (QA/QC) aspects of ISO 14160 testing include:

    1. Standard Operating Procedures (SOPs): Manufacturers must develop and implement SOPs for endotoxin removal validation.

    2. Calibration and Validation: Equipment and instruments used in testing must be calibrated and validated.

    This test contributes significantly to product safety and reliability by ensuring that manufacturers can remove endotoxins from their products.

    Competitive Advantages

    Performing ISO 14160 Endotoxin Removal Validation for Sterile Liquids testing provides:

    1. Regulatory Compliance: Companies can demonstrate compliance with national and international regulations.

    2. Quality Assurance: Manufacturers can ensure the quality and safety of their products.

    3. Customer Confidence: Companies can build trust with customers by demonstrating their commitment to product safety.

    Cost-benefit analysis reveals that performing this test provides significant benefits, including reduced regulatory risks, improved product quality, and increased customer confidence.

    Conducting ISO 14160 Endotoxin Removal Validation for Sterile Liquids testing involves:

    1. Sample Preparation: Preparing the sample according to standard procedures.

    2. Testing Equipment and Instruments: Using calibrated and validated equipment, such as turbidimeters or spectrophotometers.

    3. Testing Environment: Conducting testing in a controlled environment with specific temperature, humidity, and pressure conditions.

    Step-by-step explanation of test methodology includes:

    1. Preparation of the sample

    2. Dilution of the sample (if required)

    3. Turbidity measurement or spectrophotometric analysis

    4. Calculation of endotoxin concentration

    Quality control measures during testing include:

    1. Calibration and validation of equipment

    2. Verification of SOPs and procedures

    3. Regular maintenance and cleaning of equipment

    The test report must include:

    1. Test description: Detailed explanation of the testing methodology used.

    2. Results: Endotoxin concentration, method detection limit (MDL), and other relevant data.

    3. Conclusion: Statement on whether the manufacturers endotoxin removal process meets regulatory requirements.

    Documentation includes:

    1. Standard Operating Procedures (SOPs)

    2. Calibration records for equipment and instruments

    3. Test reports and certificates

    Accreditation and certification programs ensure that testing laboratories meet rigorous standards.

    1. ISO/IEC 17025: International standard for laboratory competency.

    2. National accreditation bodies: Such as A2LA, NVLAP, or DAkkS in the United States, Canada, or Europe.

    Laboratories must demonstrate their ability to perform accurate and reliable testing by meeting these standards.

    ISO 14160 Endotoxin Removal Validation for Sterile Liquids testing is a critical process that ensures product safety and compliance with regulatory requirements. Manufacturers must conduct this test regularly to maintain quality assurance and prevent contamination risks.

    Performing this test provides significant benefits, including reduced regulatory risks, improved product quality, and increased customer confidence.

    Recommendations

    1. Develop and implement SOPs: Standard Operating Procedures for endotoxin removal validation.

    2. Regularly calibrate equipment: Ensure accurate and reliable testing results.

    3. Maintain records and documentation: Keep test reports, calibration records, and other relevant documents up-to-date.

    By following these guidelines, manufacturers can ensure compliance with ISO 14160 and maintain the highest standards of quality and safety in their products.

    This comprehensive guide has provided a detailed overview of ISO 14160 Endotoxin Removal Validation for Sterile Liquids testing. Manufacturers must adhere to this standard to prevent contamination risks, improve product quality, and demonstrate regulatory compliance.

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