EUROLAB
iso-11138-1-biological-indicators-for-sterilization-bioburden-evaluation
Endotoxin & Bioburden Testing AAMI RD52 Endotoxin Limits for Dialysis FluidsAATCC TM100 Test for Antimicrobial Activity of TextilesANSI/AAMI ST72 Guidance on Bacterial Endotoxin Testing for Medical DevicesASTM D4414 Bioburden in Coated TextilesASTM D7295 Bioburden Testing on Coated Medical TextilesASTM E2314 Bioburden Testing in Medical Device ComponentsASTM E2406 Real-Time Endotoxin Detection Method ValidationASTM E2614 Bioburden in Industrial Water SystemsASTM E2883 Rapid Endotoxin Detection for Sterile PharmaceuticalsASTM F1608 Bacterial Filtration and Bioburden in Respiratory Protection DevicesASTM F1980 Bioburden Evaluation in Accelerated Aged ProductsASTM F2018 Endotoxin Testing of Contact Lens Care ProductsASTM F640 Bioburden Testing for Surgical DrapesEN 556 Sterilization of Medical Devices – Bioburden LimitsEN ISO 20857 Bioburden Control for Liquid Chemical SterilantsEP 2.6.1 Microbial Testing in Topical PreparationsEP 2.6.12 Microbial Limits Tests for Non-Sterile ProductsEP 2.6.14 Bacterial Endotoxins Test for Pharmaceutical PreparationsEP 2.6.25 Limulus Amebocyte Lysate Test Methods ValidationEP 2.6.30 Endotoxin Testing in Biotechnology ProductsEP 2.6.31 Limulus Amebocyte Lysate Test for EndotoxinsEP 5.1.10 Guidelines for Bioburden Testing in Advanced Therapy Medicinal ProductsEP 5.1.2 Biological Indicators for Sterilization Process ControlEP Monograph 04/2013:20619 Pyrogen and Endotoxin TestingFDA CBER Guidance on Endotoxin Testing of VaccinesFDA CDER Guidance on Bioburden Control in Drug ManufacturingFDA Guidance for Industry on Pyrogen and Endotoxin TestingISO 10993-1 Biological Evaluation of Medical Devices – Endotoxin AssessmentISO 10993-18 Bioburden Interaction with Extractables and LeachablesISO 11137-2 Sterilization Process Validation and Bioburden TestingISO 11139 Sterilization Terminology and Bioburden DefinitionsISO 11607 Packaging for Terminally Sterilized Medical Devices – Bioburden ConsiderationsISO 11607-2 Packaging for Terminal Sterilized Devices – Bioburden ConsiderationsISO 11731 Detection of Legionella in Water SystemsISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-1 Bioburden on Reusable Surgical InstrumentsISO 11737-1 Bioburden Testing for Dental ImplantsISO 11737-2 Bioburden Testing for Sterile Barrier SystemsISO 11737-2 Sterility Assurance and Bioburden ControlISO 13408-1 Aseptic Processing Bioburden ControlISO 13408-2 Aseptic Processing Microbiological MonitoringISO 14160 Endotoxin Removal Validation for Sterile LiquidsISO 14161 Bioburden Reduction Using FiltrationISO 14161 Validation of Bioburden Testing MethodsISO 14698-1 Cleanroom Biocontamination Control and MonitoringISO 14971 Risk Management of Endotoxin Contamination in Medical DevicesISO 15883-1 Bioburden Testing for Washer-DisinfectorsISO 17665-1 Moist Heat Sterilization – Bioburden ValidationISO 18562-1 Evaluation of Bioburden in Medical Devices – Part 1ISO 18562-4 Bioburden Testing in Medical Device Gas PathwaysISO 22519 Ultrafiltration Bioburden Reduction TestingISO 29621 Microbiological Examination of CosmeticsISO 80369-1 Endotoxin Limits for Small-Bore ConnectorsISO 80369-7 Small Bore Connectors Bioburden EvaluationISPE Baseline Guide Volume 7 Bioburden Control in Biopharmaceutical ManufacturingJP 15.02 Endotoxin Limit Test for Dialysis FluidsJP 4.05 Bacterial Endotoxin Test for Parenteral DrugsJP 4.06 Bacterial Endotoxin Testing of BiopharmaceuticalsJP XVII Limulus Amebocyte Lysate (LAL) Gel-Clot Test for EndotoxinsPh. Eur. Recombinant Factor C Assay for Endotoxin DetectionUSP <1050> Environmental Monitoring and Bioburden ControlUSP <1072> Disinfectants and Bioburden Control in Healthcare SettingsUSP <1111> Total Viable Count for Raw MaterialsUSP <1223> Rapid Endotoxin Test Method ValidationUSP <1223> Validation of Alternative Microbiological MethodsUSP <1225> Validation of Analytical Procedures for Endotoxin TestingUSP <1227> Validation of Microbial Recovery MethodsUSP <1229.10> Bioburden Testing in Steam SterilizationUSP <1229.12> Endotoxin Risk Assessment in Sterile ManufacturingUSP <1229.4> Microbial Testing for Aseptic Manufacturing EnvironmentsUSP <1229.9> Bioburden Validation in Isolator TechnologyUSP <1231> Bioburden Limits in Purified Water SystemsUSP <1231> Water for Pharmaceutical Purposes Microbial LimitsUSP <1232> Elemental Impurities and Bioburden ImpactUSP <61> Microbial Enumeration Test for Sterile ProductsUSP <61> Microbial Load Test for Oral Dosage FormsUSP <62> Test for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing for Ophthalmic ProductsUSP <800> Bioburden Control in Hazardous Drug CompoundingUSP <85> Bacterial Endotoxin Test for Injectable Pharmaceutical ProductsWHO TRS 1003 Endotoxin Testing Validation for Parenteral Products

ISO 11138-1 Biological Indicators for Sterilization - Bioburden Evaluation Testing Service

Provided by Eurolab: Ensuring Product Safety and Compliance

Table of Contents

1. Standard-Related Information

Overview of ISO, ASTM, EN, TSE, and other relevant standards

Legal and regulatory framework surrounding this testing service

International and national standards applicable to this specific laboratory test

2. Standard Requirements and Needs

Why this specific test is needed and required

Business and technical reasons for conducting ISO 11138-1 Biological Indicators for Sterilization Bioburden Evaluation testing

Consequences of not performing this test

3. Test Conditions and Methodology

Detailed step-by-step explanation of how the test is conducted

Testing equipment and instruments used

Testing environment requirements (temperature, humidity, pressure, etc.)

4. Test Reporting and Documentation

How test results are documented and reported

Report format and structure

Interpretation of test results

5. Why This Test Should Be Performed

Comprehensive explanation of benefits and advantages

Risk assessment and mitigation through testing

6. Why Eurolab Should Provide This Service

Expertise and experience in this field

State-of-the-art equipment and facilities

Qualified and certified personnel

ISO 11138-1 Biological Indicators for Sterilization Bioburden Evaluation testing is governed by various standards, including:

  • ISO 11138-1:2017(E) - Biological indicators for sterilization - Part 1: General requirements for biological indicators

  • ASTM E2459-13 - Standard Practice for the Preparation of Biological Indicators for Moist Heat Sterilization

  • EN 12312-2:2004 - Biological indicators for ethylene oxide sterilization

    • These standards outline the requirements for biological indicators, including their selection, preparation, and testing. The legal and regulatory framework surrounding this testing service includes:

  • EU Medical Device Regulation (MDR) 2017/745

  • US FDA regulations (21 CFR Part 111)

  • ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes)

    • This specific test is needed and required to ensure that medical devices, pharmaceuticals, and other products are free from biological contamination. The business and technical reasons for conducting this testing include:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements

  • Maintaining quality assurance and control standards

  • Preventing product recalls and liability

    • The consequences of not performing this test include:

  • Product failure or malfunction due to biological contamination

  • Regulatory non-compliance

  • Loss of customer trust and confidence

  • Financial losses due to product recall or litigation

    • This testing is required in various industries, including:

  • Medical devices

  • Pharmaceuticals

  • Food and beverage processing

  • Cosmetics and personal care products

    • The risk factors associated with this testing include:

  • Biological contamination leading to product failure or malfunction

  • Regulatory non-compliance resulting in fines or penalties

  • Loss of customer trust and confidence due to lack of quality assurance and control

    • The test is conducted in accordance with the relevant standards, including ISO 11138-1:2017(E) and ASTM E2459-13. The step-by-step procedure involves:

  • Sample preparation

  • Testing equipment and instruments used

  • Testing environment requirements (temperature, humidity, pressure, etc.)

  • Measurement and analysis methods

    • The testing parameters and conditions include:

  • Temperature range: 50C to 60C

  • Humidity range: 30 to 70

  • Pressure range: atmospheric pressure to 1 atm

    • The calibration and validation procedures involve:

  • Equipment calibration

  • Software validation

  • Quality control measures during testing

    • The test results are documented and reported in accordance with the relevant standards. The report format and structure include:

  • Test identification and description

  • Sample information and preparation details

  • Testing conditions and parameters

  • Results and interpretation

  • Conclusion and recommendations

    • The certification and accreditation aspects involve:

  • Accreditation to ISO 17025:2017 (General requirements for the competence of testing and calibration laboratories)

  • Certification to ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes)

    • This test provides numerous benefits, including:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements

  • Maintaining quality assurance and control standards

  • Preventing product recalls and liability

    • The risk assessment and mitigation through testing involve:

  • Identifying potential biological contamination risks

  • Implementing controls to prevent or mitigate these risks

  • Regular monitoring and testing to ensure compliance with regulatory requirements

    • Why Eurolab Should Provide This Service (Expertise, Experience, State-of-the-Art Equipment and Facilities)

    Eurolabs expertise and experience in this field include:

  • Extensive knowledge of relevant standards and regulations

  • State-of-the-art equipment and facilities for testing and calibration

  • Highly trained and certified personnel to perform the test

    • Conclusion

    In conclusion, ISO 11138-1 Biological Indicators for Sterilization Bioburden Evaluation testing is a critical requirement for ensuring product safety and compliance. This comprehensive guide provides an overview of the standard requirements and needs, as well as the test conditions and methodology. Eurolabs expertise and experience in this field make us the ideal partner for your bioburden evaluation testing needs.

    References

  • ISO 11138-1:2017(E) - Biological indicators for sterilization - Part 1: General requirements for biological indicators

  • ASTM E2459-13 - Standard Practice for the Preparation of Biological Indicators for Moist Heat Sterilization

  • EN 12312-2:2004 - Biological indicators for ethylene oxide sterilization

  • EU Medical Device Regulation (MDR) 2017/745

  • US FDA regulations (21 CFR Part 111)

  • ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes)

    • Please note that this is a comprehensive guide, and the specific requirements may vary depending on your organizations needs and industry.

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