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iso-11137-2-establishing-the-sterilization-dose
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 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 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 11137-2 Establishing the Sterilization Dose Laboratory Testing Service: A Comprehensive Guide

As a leading laboratory testing service provider, Eurolab is committed to delivering high-quality testing solutions that meet the stringent requirements of regulatory authorities worldwide. In this article, we will delve into the world of ISO 11137-2 Establishing the Sterilization Dose testing, exploring its significance, technical requirements, and benefits.

Standard-Related Information

ISO 11137-2 is an international standard developed by the International Organization for Standardization (ISO) that specifies the requirements for establishing the sterilization dose for radiation processing of medical devices. This standard is widely recognized as a benchmark for ensuring the effectiveness and safety of radiation sterilization processes.

Legal and Regulatory Framework

The ISO 11137-2 standard is designed to meet the regulatory requirements of various countries, including the European Union (EU), the United States, Japan, and Australia. Compliance with this standard is mandatory for medical device manufacturers who use radiation sterilization as a method for eliminating microbial contamination from their products.

International and National Standards

The ISO 11137-2 standard is part of the larger family of standards related to radiation processing, including:

  • ISO 11737-1:2018 (Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population reduction value)

  • ISO 17135:2017 (Radiation sterilization - Vocabulary)

    • Standard Development Organizations

    The development and maintenance of the ISO 11137-2 standard are the responsibilities of the following organizations:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standard Evolution and Updates

    Standards undergo periodic reviews and updates to reflect changes in technology, regulatory requirements, or industry practices. Eurolab stays up-to-date with the latest developments and ensures that our testing services align with current standards.

    Standard Numbers and Scope

    The key standard numbers related to ISO 11137-2 Establishing the Sterilization Dose testing are:

  • ISO 11137-2:2018 (Sterilization of medical devices -- Radiation -- Part 2: Establishing the sterilization dose)

  • ASTM E2307-12 (Standard Practice for Establishing the Sterilization Dose for Radiation Processing)

    • Standard Compliance Requirements

    Compliance with ISO 11137-2 is essential for various industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Food processing and packaging companies

    • Failure to comply with this standard can result in product recalls, financial losses, and damage to reputation.

    Standard Requirements and Needs

    The ISO 11137-2 standard establishes the sterilization dose for radiation processing of medical devices. This testing is crucial for ensuring the safety and efficacy of medical products that undergo radiation sterilization.

    Business and Technical Reasons

    Conducting ISO 11137-2 Establishing the Sterilization Dose testing provides several benefits, including:

  • Ensures compliance with regulatory requirements

  • Validates the effectiveness of radiation sterilization processes

  • Demonstrates product safety and reliability

  • Enhances customer confidence and trust

  • Supports international market access and trade facilitation

    • Consequences of Not Performing This Test

    Failure to perform this test can result in:

  • Non-compliance with regulatory requirements

  • Product recalls or withdrawals from the market

  • Financial losses due to non-compliance or product failures

  • Damage to reputation and brand image

    • Industries and Sectors Requiring This Testing

    The ISO 11137-2 standard applies to various industries, including medical device manufacturers, pharmaceutical companies, biotechnology firms, food processing and packaging companies, and others that use radiation sterilization as a method for eliminating microbial contamination from their products.

    Risk Factors and Safety Implications

    Radiation sterilization poses risks if not performed correctly. These risks include:

  • Radiation exposure to personnel

  • Contamination of products with ionizing radiation

  • Inadequate sterilization leading to product failures or recalls

    • Quality Assurance and Quality Control Aspects

    Eurolabs quality assurance (QA) and quality control (QC) measures ensure that our testing services meet the highest standards. These measures include:

  • Calibration and validation of equipment

  • Regular maintenance and calibration of instruments

  • Implementation of standard operating procedures (SOPs)

  • Continuous training and professional development

    • Test Conditions and Methodology

    The ISO 11137-2 testing process involves several steps, including:

    1. Sample preparation: Preparation of the test sample to ensure accurate and reliable results.

    2. Testing equipment calibration: Calibration of the testing equipment to ensure accuracy and precision.

    3. Testing environment control: Control of the testing environment to ensure consistency and reliability.

    4. Measurement and analysis: Measurement and analysis of the sterilization dose using specialized instruments.

    Benefits of ISO 11137-2 Establishing the Sterilization Dose Testing

    The benefits of conducting ISO 11137-2 Establishing the Sterilization Dose testing include:

  • Compliance with regulatory requirements

  • Validation of radiation sterilization processes

  • Enhanced product safety and reliability

  • Improved customer confidence and trust

  • Support for international market access and trade facilitation

    • Conclusion

    In conclusion, ISO 11137-2 Establishing the Sterilization Dose testing is a critical component of ensuring the safety and efficacy of medical products that undergo radiation sterilization. Compliance with this standard is essential for various industries, including medical device manufacturers, pharmaceutical companies, biotechnology firms, food processing and packaging companies.

    Eurolabs expertise in conducting ISO 11137-2 Establishing the Sterilization Dose testing ensures that our clients meet regulatory requirements, validate their radiation sterilization processes, and demonstrate product safety and reliability. Contact us today to learn more about our services and how we can help your organization achieve compliance with this standard.

    References

  • ISO 11137-2:2018 (Sterilization of medical devices -- Radiation -- Part 2: Establishing the sterilization dose)

  • ASTM E2307-12 (Standard Practice for Establishing the Sterilization Dose for Radiation Processing)

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