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iso-11138-1-biological-indicators-general-requirements
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

ISO 11138-1 Biological Indicators - General Requirements Laboratory Testing Service Provided by Eurolab: A Comprehensive Guide

Iso 11138-1 biological indicators general requirements laboratory testing is a critical process in ensuring the safety and efficacy of sterilization procedures. This article provides an in-depth overview of the relevant standards, legal and regulatory framework, and international and national standards that govern this testing service.

Relevant Standards:

  • ISO 11138-1:2017 - Sterilization of health care products -- Biological indicators -- Part 1: General requirements

  • ASTM E2198 - Standard Practice for Qualification of a Moist Heat Sterilization Process

  • EN 285 - Sterilization -- Steam sterilizers

  • TSE 2164 - Sterilizasyon Cihazları (Sterilization Devices)

    • These standards provide the framework for ensuring that biological indicators are correctly tested and validated, thereby ensuring the safety and efficacy of sterilization procedures.

    Legal and Regulatory Framework:

    The legal and regulatory framework surrounding ISO 11138-1 Biological Indicators General Requirements testing is governed by various national and international regulations. Some key regulatory bodies include:

  • FDA (Food and Drug Administration)

  • EU MDR (Medical Device Regulation)

  • ISO/TC 198 (Sterilization of medical products)

    • These regulations require manufacturers to demonstrate the effectiveness of their sterilization processes, which includes using biological indicators to validate the process.

    International and National Standards:

    The following international and national standards apply to this specific laboratory test:

  • ISO 11138-1:2017 - Sterilization of health care products -- Biological indicators -- Part 1: General requirements

  • ASTM E2198 - Standard Practice for Qualification of a Moist Heat Sterilization Process

  • EN 285 - Sterilization -- Steam sterilizers

  • TSE 2164 - Sterilizasyon Cihazları (Sterilization Devices)

    • These standards provide the framework for ensuring that biological indicators are correctly tested and validated, thereby ensuring the safety and efficacy of sterilization procedures.

    Standard Development Organizations:

    The standard development organizations responsible for developing these standards include:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • CEN (European Committee for Standardization)

    • These organizations play a crucial role in ensuring that standards are developed, maintained, and updated to reflect the latest scientific knowledge and technological advancements.

    Standards Evolution:

    Standards evolve over time as new technologies emerge, and scientific knowledge advances. This ensures that standards remain relevant and effective in ensuring the safety and efficacy of sterilization procedures.

    Standard Compliance Requirements:

    Compliance with these standards is mandatory for manufacturers who wish to demonstrate the effectiveness of their sterilization processes. Failure to comply can result in severe penalties, including product recalls, fines, and damage to reputation.

    Standard-Related Information Summary Table:

    Standard Title Scope

    --- --- ---

    ISO 11138-1:2017 Sterilization of health care products -- Biological indicators -- Part 1: General requirements Provides general requirements for biological indicators used in sterilization procedures.

    ASTM E2198 Standard Practice for Qualification of a Moist Heat Sterilization Process Provides guidance on the qualification and validation of moist heat sterilization processes.

    EN 285 Sterilization -- Steam sterilizers Specifies the design, testing, and validation requirements for steam sterilizers.

    TSE 2164 Sterilizasyon Cihazları (Sterilization Devices) Specifies the requirements for sterilization devices in Turkey.

    Iso 11138-1 biological indicators general requirements laboratory testing is a critical process in ensuring the safety and efficacy of sterilization procedures. This section explains why this specific test is needed and required.

    Why This Test Is Needed:

  • Ensures the effectiveness of sterilization procedures

  • Validates the performance of sterilization equipment

  • Provides assurance that products are free from bioburden

    • Business and Technical Reasons for Conducting ISO 11138-1 Biological Indicators General Requirements Testing:

  • Comply with regulatory requirements

  • Ensure product safety and efficacy

  • Validate sterilization processes

  • Reduce the risk of contamination and recalls

  • Improve customer confidence and trust

    • Consequences of Not Performing This Test:

  • Failure to comply with regulatory requirements

  • Risk of product contamination and recalls

  • Damage to reputation and loss of market share

  • Non-compliance with international standards and regulations

    • Industries and Sectors That Require This Testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Food and beverage industry

  • Biotechnology sector

  • Healthcare institutions

    • Risk Factors and Safety Implications:

  • Risk of product contamination and recalls

  • Damage to reputation and loss of market share

  • Non-compliance with international standards and regulations

    • Standard Requirements Summary Table:

    Standard Requirement

    --- ---

    ISO 11138-1:2017 Biological indicators must be used in sterilization procedures.

    ASTM E2198 Moist heat sterilization processes must be qualified and validated.

    EN 285 Steam sterilizers must be designed, tested, and validated according to specified requirements.

    TSE 2164 Sterilization devices must comply with specified requirements in Turkey.

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