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iso-11139-sterilization-terminology-and-bioburden-definitions
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 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

ISO 11139 Sterilization Terminology and Bioburden Definitions Laboratory Testing Service: A Comprehensive Guide

The ISO 11139 standard is a comprehensive document that provides definitions for sterilization terminology and bioburden, which are essential for ensuring the quality and safety of medical devices and pharmaceutical products. This standard is widely recognized as an international reference for the industry.

Overview of Relevant Standards

  • ISO 11139:2015: Sterilization Terminology and Bioburden

  • ASTM F1478-16: Standard Guide for Selection of Sterilization Process for Medical Devices

  • EN ISO 11137-1:2007: Sterilization of medical devices - Requirements for validation and routine control - Part 1: General requirements

  • TSE EN 556-2:2015: Sterilization of medical devices - Requirements for validation, routine testing and repeatable testing of sterilization processes

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN) are key organizations involved in the development and publication of standards related to sterilization terminology and bioburden.

    Legal and Regulatory Framework

    Compliance with ISO 11139 is mandatory for medical device manufacturers and pharmaceutical companies, as it ensures that products meet specific requirements for sterilization and bioburden control. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), enforce adherence to these standards.

    International and National Standards

  • ISO 11139:2015 is an international standard that provides definitions for sterilization terminology and bioburden.

  • EN ISO 11137-1:2007 and TSE EN 556-2:2015 are European standards that complement the requirements of ISO 11139.

    • Standard Compliance Requirements

    Medical device manufacturers and pharmaceutical companies must comply with the relevant national and international standards, such as ISO 11139, to ensure their products meet specific requirements for sterilization and bioburden control.

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    The need for ISO 11139 Sterilization Terminology and Bioburden Definitions testing arises from the importance of ensuring product safety and reliability. Compliance with this standard is crucial for manufacturers to ensure their products meet regulatory requirements.

    Business and Technical Reasons for Conducting Testing

    Conducting ISO 11139 testing ensures that products meet specific requirements for sterilization and bioburden control, which is essential for maintaining product quality and safety.

    Consequences of Not Performing This Test

    Failure to conduct this test may result in non-compliance with regulatory requirements, leading to costly recalls, reputational damage, and potential harm to patients or consumers.

    Industries and Sectors That Require This Testing

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Cosmetics and personal care products industry

    • Risk Factors and Safety Implications

    The lack of sterilization and bioburden control can lead to contamination, product failure, and potential harm to patients or consumers.

    Quality Assurance and Control Aspects

    Compliance with ISO 11139 ensures that manufacturers implement effective quality assurance and control measures to ensure product safety and reliability.

    Contribution to Product Safety and Reliability

    Conducting this test contributes significantly to maintaining product quality and safety by ensuring compliance with regulatory requirements.

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    ISO 11139 Sterilization Terminology and Bioburden Definitions testing involves a series of laboratory tests that assess the efficacy of sterilization processes and measure bioburden levels on medical devices and pharmaceutical products.

    Step-by-Step Explanation of How the Test is Conducted

    1. Sample Preparation: Samples are prepared according to the standards requirements, ensuring they are representative of the final product.

    2. Sterilization Process Validation: The sterilization process is validated using established methods, such as microbial reduction tests and chemical indicators.

    3. Bioburden Measurement: Bioburden levels are measured on samples before and after sterilization using techniques like plate counting or ATP bioluminescence.

    Testing Equipment and Instruments Used

  • Autoclaves

  • Ethylene oxide (EtO) chambers

  • Dry heat ovens

  • Microbiological testing equipment (e.g., incubators, microscopes)

    • Testing Environment Requirements

  • Temperature control ( 1C)

  • Humidity control ( 5)

  • Pressure control ( 10)

    • Sample Preparation Procedures

    Samples are prepared according to the standards requirements, ensuring they are representative of the final product.

    Measurement Techniques for Bioburden Levels

    Plate counting and ATP bioluminescence are commonly used techniques for measuring bioburden levels on samples before and after sterilization.

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    Perspective: ISO 11139 Sterilization Terminology and Bioburden Definitions Laboratory Testing Service

    ISO 11139 Sterilization Terminology and Bioburden Definitions testing is a critical component of ensuring product safety and reliability in the medical device and pharmaceutical industries. By conducting this test, manufacturers can ensure compliance with regulatory requirements and maintain confidence in their products.

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    Conclusion:

    The importance of ISO 11139 Sterilization Terminology and Bioburden Definitions laboratory testing cannot be overstated. Manufacturers must adhere to these standards to ensure product safety and reliability. Compliance with these regulations is crucial for preventing costly recalls, maintaining reputations, and safeguarding public health.

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