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iso-11138-4-biological-indicators-for-dry-heat-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 11138-5 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 11138-4 Biological Indicators for Dry Heat Sterilization Processes Laboratory Testing Service

Provided by Eurolab

ISO 11138-4 is a standard that governs the testing of biological indicators for dry heat sterilization processes. This standard is part of the ISO 11138 series, which provides guidelines for the validation and verification of sterilization processes using biological indicators.

International and National Standards

The international standards that apply to this specific laboratory test include:

  • ISO 11138-4:2019 - Biological indicators -- Dry heat sterilization -- Part 4: General requirements for dried products

  • ASTM E2421-17 - Standard Guide for Validation of Hot Air and Ethylene Oxide Sterilization Cycles

    • The national standards that apply to this specific laboratory test include:

  • EN ISO 11138-4:2019 - Biological indicators -- Dry heat sterilization -- Part 4: General requirements for dried products

  • TSE ISO 11138-4:2019 - Biological indicators -- Dry heat sterilization -- Part 4: General requirements for dried products

    • Standard Development Organizations and Their Role

    The standard development organizations that govern the development of ISO 11138-4 include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations play a crucial role in ensuring that the standards are up-to-date, accurate, and relevant to the needs of industry.

    Evolution and Update of Standards

    Standards evolve and get updated regularly to reflect changes in technology, regulations, and best practices. The ISO 11138-4 standard has undergone several revisions since its initial publication in 1995.

    The current version of the standard (ISO 11138-4:2019) reflects the latest developments in dry heat sterilization processes and provides more stringent requirements for biological indicator testing.

    Standard Compliance Requirements

    Industry compliance with ISO 11138-4 is mandatory for manufacturers that use dry heat sterilization processes to ensure the sterility of their products. Failure to comply with this standard can result in product recalls, regulatory fines, and damage to reputation.

    Business and Technical Reasons for Conducting ISO 11138-4 Biological Indicators for Dry Heat Sterilization Processes Testing

    The main reasons for conducting ISO 11138-4 biological indicators for dry heat sterilization processes testing include:

  • Ensuring product sterility

  • Preventing product contamination

  • Maintaining regulatory compliance

  • Enhancing product safety and reliability

  • Improving quality assurance and control

    • Consequences of Not Performing This Test

    Failure to perform this test can result in the following consequences:

  • Product recalls due to contamination or non-sterility

  • Regulatory fines and penalties for non-compliance

  • Damage to reputation and brand image

  • Loss of customer confidence and trust

  • Increased costs associated with rework, repair, or replacement

    • Industries and Sectors that Require This Testing

    The following industries and sectors require this testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Food processing and packaging companies

  • Biotechnology firms

  • Cosmetics and personal care products manufacturers

    • Detailed Step-by-Step Explanation of How the Test is Conducted

    The test is conducted as follows:

    1. Sample preparation: The biological indicator is prepared according to the manufacturers instructions.

    2. Testing equipment and instruments: The testing equipment and instruments used include a hot air oven, temperature control unit, humidity control unit, and data acquisition system.

    3. Testing environment requirements: The testing environment requires a controlled atmosphere with precise temperature and humidity conditions.

    4. Sample preparation procedures: The biological indicator is placed in the hot air oven and exposed to dry heat sterilization conditions for a specified period.

    5. Testing parameters and conditions: The testing parameters and conditions include temperature, humidity, pressure, and exposure time.

    6. Measurement and analysis methods: The measurement and analysis methods used include microbiological enumeration, biological indicator recovery, and statistical analysis.

    Quality Control Measures During Testing

    Quality control measures during testing include:

  • Calibration of equipment

  • Validation of test procedures

  • Training of personnel

  • Document control and record keeping

    • Explanation of How Test Results are Documented and Reported

    The test results are documented and reported as follows:

    1. Report format: The report includes a summary of the testing, results, and conclusions.

    2. Interpretation of test results: The interpretation of test results is based on the requirements specified in the standard.

    3. Statistical analysis: Statistical analysis is performed to determine the significance of the test results.

    Industries and Sectors that Require This Testing

    The following industries and sectors require this testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Food processing and packaging companies

  • Biotechnology firms

  • Cosmetics and personal care products manufacturers

    • Conclusion

    In conclusion, ISO 11138-4 biological indicators for dry heat sterilization processes testing is a critical component of ensuring product sterility, preventing contamination, and maintaining regulatory compliance. Industry compliance with this standard is mandatory, and failure to comply can result in serious consequences.

    By understanding the requirements and needs of this standard, manufacturers can ensure that their products meet the necessary standards and regulations, thereby enhancing product safety and reliability.

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