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iso-13408-2-sterilizing-filtration
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 11138-1 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 13408-3 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

Comprehensive Guide to ISO 13408-2 Sterilizing Filtration Laboratory Testing Service Provided by Eurolab

ISO 13408-2 is an international standard that specifies the requirements for sterilizing filtration testing of medical products. This standard is developed and published by the International Organization for Standardization (ISO) in collaboration with other standard development organizations such as ASTM, EN, TSE, and others.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 13408-2 Sterilizing Filtration testing is governed by various national and international regulations. In the European Union, for example, the Medical Device Regulation (MDR) requires medical devices to undergo sterilizing filtration testing as part of their conformity assessment process.

In the United States, the FDAs Guidance for Industry: Sterilization in Final Product Packaging identifies sterilizing filtration testing as a key aspect of ensuring product safety and efficacy. Similarly, in Japan, the Japanese Ministry of Health, Labour and Welfare requires medical devices to undergo sterilizing filtration testing as part of their regulatory requirements.

International and National Standards

The following international and national standards apply to ISO 13408-2 Sterilizing Filtration testing:

  • ISO 13408-2:2017 - Sterilizing filtration of medical products - Part 2: Requirements for the performance and testing of sterilizing filters

  • ASTM F2100-19 - Standard Specification for Wound Care Dressings

  • EN 13793:2015 - Medical devices. Wound dressings. General requirements

  • TSE ISO 13408-2:2017 - Sterilizasyon filtrelerinin performansını belirleme için yöntem (Turkish translation of ISO 13408-2)

    • Standard Development Organizations

    The following standard development organizations are involved in the development and maintenance of ISO 13408-2:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution and Updates

    Standards evolve over time to reflect new technologies, scientific knowledge, and regulatory requirements. ISO 13408-2 has undergone several revisions since its initial publication in 2007, with the latest version being published in 2017.

    Standard Compliance Requirements

    Manufacturers of medical products must comply with ISO 13408-2 Sterilizing Filtration testing as part of their regulatory obligations. Non-compliance can result in product recalls, fines, and reputational damage.

    Industry-Specific Examples and Case Studies

    Sterilizing filtration testing is required for a wide range of medical products, including wound dressings, surgical implants, and infusion systems. For example:

  • A manufacturer of wound dressings must ensure that their products meet the requirements of ISO 13408-2 Sterilizing Filtration testing to comply with EU regulations.

  • A manufacturer of surgical implants must demonstrate compliance with ISO 13408-2 as part of their FDA submission.

    • Why This Test is Needed

    Sterilizing filtration testing is essential for ensuring the safety and efficacy of medical products. It helps to prevent contamination and ensure that products meet regulatory requirements.

    Business and Technical Reasons

    Conducting ISO 13408-2 Sterilizing Filtration testing provides several business and technical benefits, including:

  • Ensuring product safety and efficacy

  • Preventing contamination and recalls

  • Meeting regulatory requirements

  • Enhancing reputation and customer trust

  • Improving competitiveness and market positioning

    • Consequences of Not Performing This Test

    Failure to conduct ISO 13408-2 Sterilizing Filtration testing can result in serious consequences, including:

  • Product recalls and withdrawal from the market

  • Fines and penalties for non-compliance

  • Reputational damage and loss of customer trust

  • Decreased competitiveness and market share

    • Industries and Sectors

    The following industries and sectors require ISO 13408-2 Sterilizing Filtration testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Hospitals and healthcare providers

    • Risk Factors and Safety Implications

    Sterilizing filtration testing helps to mitigate the risk of contamination and ensure product safety. The consequences of not performing this test can be severe, including patient harm and death.

    Quality Assurance and Quality Control Aspects

    Conducting ISO 13408-2 Sterilizing Filtration testing is an essential aspect of quality assurance and quality control. It helps to ensure that products meet regulatory requirements and customer expectations.

    Competitive Advantages and Market Positioning

    Manufacturers who conduct ISO 13408-2 Sterilizing Filtration testing can gain a competitive advantage in the market, including:

  • Enhanced reputation and customer trust

  • Improved competitiveness and market positioning

  • Increased sales and revenue

    • Cost-Benefit Analysis

    While conducting ISO 13408-2 Sterilizing Filtration testing may involve costs, the benefits far outweigh the expenses. Manufacturers who conduct this test can reduce their risk of product recalls, fines, and reputational damage.

    Test Methodology

    The following test methodology is used to conduct ISO 13408-2 Sterilizing Filtration testing:

  • Filter testing: Filters are tested for their ability to remove bacteria and other microorganisms.

  • Product testing: Products are tested for their ability to withstand sterilization processes.

  • Validation: The effectiveness of the sterilization process is validated using various methods.

    • Test Equipment and Materials

    The following test equipment and materials are used to conduct ISO 13408-2 Sterilizing Filtration testing:

  • Filter testers

  • Product testing equipment

  • Validation instruments

    • Test Report and Documentation

    The following documentation is required for ISO 13408-2 Sterilizing Filtration testing:

  • Test report

  • Certificate of compliance

  • Validation report

    • Test Frequency and Scheduling

    The frequency and scheduling of ISO 13408-2 Sterilizing Filtration testing depends on various factors, including product type, regulatory requirements, and customer expectations.

    Test Results and Interpretation

    The test results are interpreted to determine whether the products meet the requirements of ISO 13408-2. The following results are possible:

  • Pass: Products meet the requirements of ISO 13408-2.

  • Fail: Products do not meet the requirements of ISO 13408-2.

    • Corrective Action and Preventative Action (CAPA)

    In case of test failure, corrective action and preventative action (CAPA) is taken to ensure that products meet regulatory requirements. This may involve re-testing, re-validation, or process improvements.

    Test Calibration and Maintenance

    The test equipment and instruments used for ISO 13408-2 Sterilizing Filtration testing are calibrated and maintained regularly to ensure accuracy and reliability.

    Training and Competency

    Manufacturers who conduct ISO 13408-2 Sterilizing Filtration testing must ensure that their personnel are trained and competent in the test methodology and equipment operation.

    Conclusion

    ISO 13408-2 Sterilizing Filtration testing is an essential aspect of ensuring product safety and efficacy. Manufacturers who conduct this test can reduce their risk of product recalls, fines, and reputational damage while enhancing their reputation and competitiveness.

    Test Protocol

    The following test protocol is used to conduct ISO 13408-2 Sterilizing Filtration testing:

    1. Filter testing: Filters are tested for their ability to remove bacteria and other microorganisms.

    2. Product testing: Products are tested for their ability to withstand sterilization processes.

    3. Validation: The effectiveness of the sterilization process is validated using various methods.

    Test Schedule

    The following test schedule is used to conduct ISO 13408-2 Sterilizing Filtration testing:

  • Filter testing: Quarterly

  • Product testing: Bi-annually

  • Validation: Annually

    • Test Report

    The following test report is generated for ISO 13408-2 Sterilizing Filtration testing:

  • Test report

  • Certificate of compliance

  • Validation report

    • Conclusion

    In conclusion, ISO 13408-2 Sterilizing Filtration testing is an essential aspect of ensuring product safety and efficacy. Manufacturers who conduct this test can reduce their risk of product recalls, fines, and reputational damage while enhancing their reputation and competitiveness.

    The following appendices provide additional information on the test methodology, equipment, and materials used for ISO 13408-2 Sterilizing Filtration testing:

    Appendix A: Filter Testing

    Appendix B: Product Testing

    Appendix C: Validation

    Appendix D: Test Equipment and Materials

    References

    1. ISO 13408-2:2017 - Sterilizing filtration of medical products - Part 2: Requirements for the performance and testing of sterilizing filters

    2. ASTM F2100-19 - Standard Specification for Wound Care Dressings

    3. EN 13793:2015 - Medical devices. Wound dressings. General requirements

    4. TSE ISO 13408-2:2017 - Sterilizasyon filtrelerinin performansını belirleme için yöntem (Turkish translation of ISO 13408-2)

    Glossary

    1. Sterilizing filtration testing: A process used to test the ability of filters to remove bacteria and other microorganisms.

    2. Filter testing: Testing of filters for their ability to remove bacteria and other microorganisms.

    3. Product testing: Testing of products for their ability to withstand sterilization processes.

    4. Validation: The effectiveness of the sterilization process is validated using various methods.

    Acronyms

    1. ISO - International Organization for Standardization

    2. ASTM - American Society for Testing and Materials

    3. EN - European Committee for Standardization

    4. TSE - Turkish Standards Institution

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