EUROLAB
iso-11138-3-biological-indicators-for-steam-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 11138-4 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

Comprehensive Guide to ISO 11138-3 Biological Indicators for Steam Sterilization Processes Laboratory Testing Service

Provided by Eurolab

Table of Contents

1. Standard-Related Information

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Overview of relevant standards

Legal and regulatory framework

International and national standards

Standard development organizations

Evolution and updates of standards

Specific standard numbers and their scope

Compliance requirements for industries

2. Standard Requirements and Needs

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Business and technical reasons for testing

Consequences of not performing the test

Industries and sectors requiring this testing

Risk factors and safety implications

Quality assurance and control aspects

Contribution to product safety and reliability

Competitive advantages

Cost-benefit analysis

3. Test Conditions and Methodology

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Step-by-step explanation of the test

Testing equipment and instruments used

Testing environment requirements

Sample preparation procedures

Testing parameters and conditions

Measurement and analysis methods

Calibration and validation procedures

Quality control measures during testing

Data collection and recording procedures

Testing timeframes and duration

4. Test Reporting and Documentation

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Documentation of test results

Report format and structure

Interpretation of test results

Certification and accreditation aspects

Traceability and documentation requirements

Reporting standards and formats

Validation and verification of results

Electronic reporting systems used

5. Why This Test Should Be Performed

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Benefits and advantages of testing

Risk assessment and mitigation through testing

Quality assurance and compliance benefits

Competitive advantages and market positioning

Cost savings and efficiency improvements

Legal and regulatory compliance benefits

Customer confidence and trust building

International market access and trade facilitation

Innovation and research development support

6. Why Eurolab Should Provide This Service

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Expertise and experience in this field

State-of-the-art equipment and facilities

Qualified and certified personnel

Accreditation and certification details

International recognition and partnerships

Quality management systems and procedures

Customer service and support capabilities

Standard-Related Information

ISO 11138-3 is a standard that governs the testing of biological indicators for steam sterilization processes. This standard is part of the ISO 11138 series, which covers the testing of biological indicators for various types of sterilization processes.

  • International Organization for Standardization (ISO): ISO is an independent, non-governmental organization that develops and publishes international standards for a wide range of industries.

  • European Committee for Standardization (CEN): CEN is responsible for developing and publishing European standards in various fields, including health care and medical devices.

  • American Society for Testing and Materials (ASTM): ASTM is a voluntary organization that develops and publishes standards for materials, products, and services.

    • Legal and Regulatory Framework

    The testing of biological indicators for steam sterilization processes is governed by various laws and regulations. These include:

  • Good Manufacturing Practice (GMP) regulations: GMP regulations require manufacturers to follow specific guidelines for the production and testing of medical devices and pharmaceuticals.

  • Regulatory requirements for medical devices: Regulatory bodies, such as the US FDA and EU authorities, have established specific requirements for the testing and evaluation of medical devices.

    • Standard Requirements and Needs

    The testing of biological indicators for steam sterilization processes is necessary to ensure that medical devices and equipment are properly sterilized. This test helps to:

  • Validate sterilization processes: The test ensures that sterilization processes meet the required standards, reducing the risk of contamination and ensuring patient safety.

  • Meet regulatory requirements: Manufacturers must comply with regulatory requirements for testing and evaluation, and this test helps them to do so.

    • Test Conditions and Methodology

    The test involves the following steps:

    1. Sample preparation: Biological indicators are prepared according to the standard.

    2. Testing equipment and instruments: Specialized equipment and instruments are used to conduct the test.

    3. Testing environment requirements: The testing environment must meet specific temperature, humidity, and pressure requirements.

    4. Measurement and analysis methods: Results are measured and analyzed using specialized equipment and software.

    Test Reporting and Documentation

    The results of the test are documented in a report that includes:

  • Test results: The report details the results of the test, including any deviations from the standard.

  • Conclusion: The report concludes whether the sterilization process meets the required standards.

    • Why This Test Should Be Performed

    This test should be performed because it helps to ensure patient safety and regulatory compliance. It also provides a competitive advantage by demonstrating a commitment to quality and safety.

    Why Eurolab Should Provide This Service

    Eurolab is an expert in this field, with state-of-the-art equipment and facilities. Our team of qualified and certified personnel ensures that the test is conducted accurately and efficiently.

    Conclusion

    The testing of biological indicators for steam sterilization processes is a critical step in ensuring patient safety and regulatory compliance. Eurolab has the expertise and resources to conduct this test accurately and efficiently, providing valuable benefits to our clients.

    By following these guidelines, manufacturers can ensure that their medical devices and equipment meet the required standards, reducing the risk of contamination and ensuring patient safety.

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