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iso-14161-bioburden-reduction-using-filtration
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 11138-1 Biological Indicators for Sterilization – Bioburden EvaluationISO 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 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 14161 Bioburden Reduction Using Filtration Laboratory Testing Service

ISO 14161 is a widely recognized international standard that governs the laboratory testing of bioburden reduction using filtration. This standard is published by the International Organization for Standardization (ISO) and is applicable to various industries, including pharmaceutical, medical device, food, and cosmetics.

The ISO 14161 standard outlines the requirements for conducting bioburden reduction testing using filtration methods. The standard specifies the test conditions, sample preparation procedures, and analysis methods to be used when evaluating the bioburden-reducing properties of a product or material.

Standard Development Organizations and Their Role

ISO is a non-profit organization that develops and publishes international standards for various industries. ISO collaborates with other standard development organizations (SDOs), such as the American Society for Testing and Materials (ASTM) and the European Committee for Standardization (CEN), to develop and maintain standards.

The role of SDOs in developing standards is to provide a framework for manufacturers, regulators, and users to ensure that products and services meet specific requirements. SDOs also facilitate the exchange of ideas, expertise, and best practices among members.

International and National Standards

ISO 14161 is an international standard that has been adopted by many countries worldwide. The standard is also recognized by national standards organizations, such as the American Society for Testing and Materials (ASTM) and the European Committee for Standardization (CEN).

In addition to ISO 14161, other relevant international and national standards include:

  • ASTM E2111: Standard Test Method for Determining the Effects of Filtration on Bacterial Retention

  • CEN/TS 16777: Bioburden reduction by filtration - Requirements for testing

  • TSE EN ISO 14161: Turkish Standard for Bioburden Reduction Using Filtration

    • Standard Compliance Requirements

    Manufacturers and suppliers must comply with relevant standards to ensure that their products meet specific requirements. This includes implementing quality management systems (QMS) and adhering to regulatory requirements.

    Compliance with standards is essential for several reasons:

  • Ensures product safety and efficacy

  • Meets regulatory requirements

  • Enhances market access and competitiveness

  • Supports innovation and research development

    • Standard Evolution and Updates

    Standards are regularly reviewed and updated to reflect changes in technology, science, and industry needs. SDOs engage stakeholders, including manufacturers, regulators, and users, to ensure that updates are relevant and practical.

    ISO 14161 has undergone several revisions since its initial publication. The most recent version (2019) incorporates new test methods and requirements for evaluating bioburden reduction using filtration.

    Standard-Related Requirements

    The following are some of the key standard-related requirements for ISO 14161:

  • Testing equipment and instruments

  • Sample preparation procedures

  • Analysis methods

  • Calibration and validation procedures

  • Quality control measures during testing

  • Data collection and recording procedures

    • ISO 14161 bioburden reduction using filtration testing is essential for various industries, including:

  • Pharmaceutical: To ensure product safety and efficacy

  • Medical Device: To evaluate the biocompatibility of materials

  • Food: To detect microbial contaminants

  • Cosmetics: To assess product sterility

    • Business and Technical Reasons

    Performing ISO 14161 testing provides several benefits, including:

  • Ensures product safety and efficacy

  • Meets regulatory requirements

  • Enhances market access and competitiveness

  • Supports innovation and research development

  • Reduces risk factors and safety implications

    • The consequences of not performing this test are severe, including:

  • Product recalls and withdrawals

  • Regulatory penalties and fines

  • Loss of market share and reputation

  • Increased costs for corrective actions

    • Risk Factors and Safety Implications

    Bioburden reduction using filtration testing helps identify potential risks associated with products or materials. The standard assesses the effectiveness of filtration methods in reducing bioburden, ensuring that products are safe for use.

    The following risk factors and safety implications are relevant to ISO 14161:

  • Microbial contamination

  • Product sterility

  • Biocompatibility of materials

  • Environmental and sustainability considerations

    • Quality Assurance and Quality Control Aspects

    Performing ISO 14161 testing is essential for ensuring product quality and reliability. The standard emphasizes the importance of quality assurance and quality control measures, including:

  • Calibration and validation procedures

  • Data collection and recording procedures

  • Quality control measures during testing

  • Testing equipment and instruments

    • ISO 14161 bioburden reduction using filtration testing is conducted in a controlled laboratory environment. The following are the step-by-step procedures for conducting the test:

    1. Sample Preparation: Prepare the sample according to the standards requirements.

    2. Filtration: Filter the sample using a membrane filter with a specific pore size and material.

    3. Analysis: Analyze the filtered sample using a suitable method, such as microbial counting or PCR (polymerase chain reaction).

    4. Calculation: Calculate the bioburden reduction factor (BRF) based on the analysis results.

    Test Equipment and Instruments

    The following are some of the test equipment and instruments required for ISO 14161 testing:

  • Membrane filters with specific pore sizes and materials

  • Sterilization equipment, such as autoclaves or sterile air ovens

  • Microbial counting equipment, including petri dishes and incubators

  • PCR equipment, including thermocyclers and gel electrophoresis units

    • Test Methods

    The standard specifies several test methods for evaluating bioburden reduction using filtration. These include:

  • Microbial counting method (MCM)

  • PCR method (PM)

  • DNA extraction and PCR method (DEP)

    • Data Collection and Recording Procedures

    Data collection and recording procedures are essential for ISO 14161 testing. The following are some of the requirements:

  • Record all test results, including sample identification, filtration parameters, and analysis data.

  • Maintain a database or spreadsheet for storing and analyzing test data.

  • Use statistical methods to analyze and interpret test results.

    • Conclusion

    ISO 14161 bioburden reduction using filtration testing is essential for various industries. The standard ensures product safety and efficacy by evaluating the effectiveness of filtration methods in reducing bioburden.

    Manufacturers, suppliers, and users must comply with relevant standards to ensure that their products meet specific requirements. Compliance with standards supports innovation, research development, and market access while reducing risk factors and safety implications.

    Standard-Related Requirements

    The following are some of the key standard-related requirements for ISO 14161:

  • Testing equipment and instruments

  • Sample preparation procedures

  • Analysis methods

  • Calibration and validation procedures

  • Quality control measures during testing

  • Data collection and recording procedures

    • This comprehensive guide to ISO 14161 bioburden reduction using filtration laboratory testing service provides an overview of the standards requirements, test conditions, and methodology. The information in this document is intended to assist manufacturers, suppliers, and users in understanding the importance of complying with standards.

    Recommendations

    To ensure compliance with ISO 14161, we recommend:

  • Implementing a quality management system (QMS)

  • Adhering to regulatory requirements

  • Maintaining accurate records of test results and data collection

  • Regularly reviewing and updating standards to reflect changes in technology and industry needs

    • By following these recommendations, manufacturers, suppliers, and users can ensure that their products meet specific requirements and maintain a competitive edge in the market.

    References

  • ISO 14161:2019 - Bioburden reduction by filtration - Requirements for testing

  • ASTM E2111: Standard Test Method for Determining the Effects of Filtration on Bacterial Retention

  • CEN/TS 16777: Bioburden reduction by filtration - Requirements for testing

  • TSE EN ISO 14161: Turkish Standard for Bioburden Reduction Using Filtration

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