EUROLAB
iso-14937-general-requirements-for-sterilization-processes
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 13408-2 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 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 14937 General Requirements for Sterilization Processes Testing Services by Eurolab

Standard-Related Information

ISO 14937 is a globally recognized standard that outlines the general requirements for sterilization processes testing. This standard provides a framework for evaluating the effectiveness of sterilization methods, ensuring that products are free from microbial contamination and meet regulatory requirements.

Relevant Standards

The following standards govern ISO 14937 General Requirements for Sterilization Processes testing:

  • ISO 11135: Sterilization of medical instruments and equipment

  • ASTM E2454: Sterilization of healthcare products by ionizing radiation

  • EN 285: Sterilization of medical devices using dry heat

  • TSE 2153: Sterilization of medical devices using ethylene oxide

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding ISO 14937 General Requirements for Sterilization Processes testing is governed by international standards, national regulations, and industry-specific guidelines.

  • International Standards: ISO 11135, ASTM E2454, EN 285, and TSE 2153 provide the technical requirements for sterilization processes testing.

  • National Regulations: Each country has its own set of regulations governing sterilization processes testing. For example, in the European Union, Regulation (EU) 2017/745 sets out the requirements for medical device conformity assessment.

  • Industry-Specific Guidelines: Various industry-specific guidelines and recommendations provide additional guidance on sterilization processes testing.

    • Standard Development Organizations

    Standard development organizations play a crucial role in creating and maintaining standards. The main standard development organizations involved in ISO 14937 General Requirements for Sterilization Processes testing are:

  • ISO (International Organization for Standardization): Develops and publishes international standards, including ISO 11135, ASTM E2454, EN 285, and TSE 2153.

  • ASTM (American Society for Testing and Materials): Develops and publishes technical standards for various industries, including sterilization processes testing.

  • EN (European Standard): Develops and publishes European standards, including EN 285.

    • Standard Evolution

    Standards evolve over time to reflect advances in technology, changes in regulatory requirements, or industry-specific needs. This evolution is driven by:

  • New Research Findings: Advances in research and development lead to updates in standardization.

  • Regulatory Changes: Updates to national regulations or international standards necessitate revisions to the standard.

  • Industry Feedback: Stakeholders provide input on areas for improvement, leading to modifications in the standard.

    • Standard Numbers and Scope

    The following are some key standard numbers and their scope:

    Standard Number Title Scope

    --- --- ---

    ISO 11135 Sterilization of medical instruments and equipment Covers sterilization methods using ethylene oxide.

    ASTM E2454 Sterilization of healthcare products by ionizing radiation Focuses on sterilization using gamma, electron beam, or X-ray radiation.

    Compliance Requirements

    Compliance with ISO 14937 General Requirements for Sterilization Processes testing is mandatory in various industries:

  • Medical Devices: Manufacturers must ensure their devices meet the required standards.

  • Pharmaceuticals: Companies must comply with sterilization requirements for product packaging and equipment.

    • ---

    Standard Requirements and Needs

    Why is this test needed?

    ISO 14937 General Requirements for Sterilization Processes testing ensures that products are free from microbial contamination, meeting regulatory requirements. This test is essential in various industries, including:

  • Medical Devices: To ensure device safety and efficacy.

  • Pharmaceuticals: To prevent product contamination.

    • Business and Technical Reasons

    Conducting ISO 14937 General Requirements for Sterilization Processes testing has several business and technical reasons:

  • Product Safety: Ensures that products meet regulatory requirements, reducing the risk of product recalls.

  • Regulatory Compliance: Demonstrates compliance with international standards and national regulations.

  • Quality Assurance: Enhances quality assurance by identifying potential issues early in the production process.

    • Consequences of Not Performing this Test

    Failure to perform ISO 14937 General Requirements for Sterilization Processes testing may result in:

  • Product Recalls: Contaminated products can lead to recalls, damaging a companys reputation.

  • Regulatory Penalties: Non-compliance with regulations can result in fines and penalties.

  • Loss of Business: Companies that fail to meet standards may lose business opportunities.

    • ---

    Test Conditions and Methodology

    Test Conduct

    The test is conducted as follows:

    1. Sample Preparation: Samples are prepared according to the relevant standard.

    2. Testing Equipment: Appropriate equipment is selected for the specific sterilization method (e.g., ethylene oxide or ionizing radiation).

    3. Environmental Control: The testing environment is controlled to ensure optimal conditions (temperature, humidity, pressure).

    Test Parameters and Conditions

    The following parameters are considered during testing:

  • Temperature: Controlled temperature to ensure optimal sterilization.

  • Humidity: Maintained humidity levels to prevent moisture-related issues.

    • ---

    Conclusion

    In conclusion, ISO 14937 General Requirements for Sterilization Processes testing is a critical component of ensuring product safety and regulatory compliance. Manufacturers must comply with international standards and national regulations to avoid product recalls, regulatory penalties, or loss of business opportunities.

    By following the guidelines outlined in this comprehensive guide, manufacturers can ensure their products meet the required standards and regulations.

    Recommendations

    Based on the information provided:

  • Conduct regular audits and assessments to ensure compliance.

  • Provide training to employees on sterilization processes testing procedures.

  • Stay up-to-date with changes in regulatory requirements and industry-specific guidelines.

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers