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iso-11737-2-sterility-assurance-and-validation-for-pharmaceutical-components
Pharmaceutical Microbiology Testing ICH Q10 Pharmaceutical Quality System and Microbial ControlsICH Q6A Testing for Microbiological Attributes of Drug SubstancesICH Q7 GMP Guidelines for Microbial Control in APIsICH Q9 Risk-Based Approach to Microbial ContaminationISO 11737-1 Bioburden Testing for Medical Devices and Pharmaceutical PackagingISO 11930 Preservation Efficacy Testing for Topical PharmaceuticalsISO 14644-1 Cleanroom Classification for Pharmaceutical ManufacturingISO 14698-1 Biocontamination Control in CleanroomsISO 16212 Yeast and Mold Testing in Pharmaceutical Raw MaterialsISO 18415 Detection of Pathogenic Microorganisms in Non-Sterile ProductsISO 21149 Enumeration of Aerobic Mesophilic Bacteria in Cosmetic and PharmaJP XVII Bacterial Endotoxin Test for Injectable PharmaceuticalsJP XVII Microbial Limit Tests for Oral PreparationsJP XVII Sterility Test for Pharmaceutical ProductsPh. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical ProductsPh. Eur. 2.6.11 Detection of Pathogens in Veterinary PharmaceuticalsPh. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile ProductsPh. Eur. 2.6.13 Detection of Clostridia in Parenteral SolutionsPh. Eur. 2.6.14 Bacterial Endotoxins – Gel Clot MethodPh. Eur. 2.6.15 Test for Pseudomonas aeruginosa in Topical DrugsPh. Eur. 2.6.16 Test for Staphylococcus aureus in Creams and GelsPh. Eur. 2.6.2 Mycoplasma Detection in Cell-Based PharmaceuticalsPh. Eur. 2.6.25 Testing for Anaerobic Bacteria in Sterile ProductsPh. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral DrugsPh. Eur. 2.6.30 Monitoring of Controlled EnvironmentsPh. Eur. 2.6.32 Control of Bacterial Contamination in Ophthalmic DrugsPh. Eur. 2.6.7 Mycobacteria Detection in BiopharmaceuticalsPh. Eur. 2.6.9 Test for Escherichia coli in Non-Sterile PharmaPh. Eur. 5.1.4 Microbiological Quality of Pharmaceutical PreparationsPh. Eur. 5.1.6 Alternative Methods for Microbiological Quality ControlPh. Eur. 5.1.8 Bioburden Limits in Parenteral ManufacturingUSP <1072> Disinfectants and Antiseptics Microbial Efficacy TestUSP <1111> Microbiological Examination of Non-Sterile ProductsUSP <1115> Bioburden Control of Non-Sterile Drug SubstancesUSP <1116> Microbiological Control of Clean Rooms and Controlled EnvironmentsUSP <1117> Microbial Best Practices for Pharmaceutical Lab PersonnelUSP <1207> Package Integrity Evaluation – Microbial Ingress TestUSP <1208> Integrity Testing for Sterile Barrier SystemsUSP <1223> Water Activity Determination in Drug ProductsUSP <1227> Validation of Microbial Recovery MethodsUSP <1229> Microbial Quality of Compendial Water SystemsUSP <1231> Water for Pharmaceutical Purposes – Microbiological TestingUSP <39> Bioburden Limit Testing for Bulk Active IngredientsUSP <39> Microbiological Quality of Compounding PharmaciesUSP <51> Preservative Effectiveness Testing of Multi-Dose PharmaceuticalsUSP <55> Biological Indicators for Sterilization ValidationUSP <61> Microbial Enumeration Tests for Raw Pharmaceutical MaterialsUSP <61>/<62> Microbial Limit Tests for Tablet and Capsule FormsUSP <62> Tests for Specified Microorganisms in Non-Sterile ProductsUSP <71> Sterility Testing of Injectable Pharmaceutical Products

Comprehensive Guide to ISO 11737-2 Sterility Assurance and Validation for Pharmaceutical Components Testing Services Provided by Eurolab

ISO 11737-2 is an international standard that provides guidelines for the testing of sterility assurance and validation for pharmaceutical components. This standard is part of a larger family of ISO standards, which are developed and published by the International Organization for Standardization (ISO).

The ISO 11737-2 standard applies to the testing of sterile products, including injectable solutions, powders, and lyophilized preparations. The standard specifies the requirements for sterility testing, including the methods used, the equipment required, and the documentation needed.

In addition to the ISO 11737-2 standard, there are other relevant standards that govern this type of testing. These include:

  • ASTM E2454-14: Standard Practice for Sterilization Validation

  • EN 556-1:1997A1:2003: Sterilization by ionizing radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process

  • TSE EN ISO 11140-1:2014: Sterilization of medical devices - Integrated routine tests - Part 1: General requirements

    • These standards provide a framework for ensuring that sterile products are manufactured in accordance with good manufacturing practices (GMPs) and regulatory requirements.

    Standard Development Organizations and their Role

    The International Organization for Standardization (ISO) is responsible for the development, publication, and maintenance of ISO standards. The ISO is a non-governmental organization that brings together experts from over 160 countries to develop and promote international standards.

    In addition to the ISO, there are other standard development organizations that contribute to the development of standards related to sterilization validation and testing. These include:

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations work together to develop and maintain standards that meet the needs of industry, regulatory bodies, and other stakeholders.

    How Standards Evolve and Get Updated

    Standards are constantly evolving as new technologies, practices, and regulations emerge. The ISO 11737-2 standard, for example, was first published in 1998 and has undergone several revisions since then. The most recent revision was published in 2019.

    The process of updating standards involves a thorough review of the existing standard, including consultation with industry experts, regulatory bodies, and other stakeholders. This ensures that the updated standard remains relevant and effective in meeting the needs of industry and regulatory requirements.

    International and National Standards

    In addition to the ISO 11737-2 standard, there are national and international standards that govern this type of testing. These include:

  • EU GMP (European Union Good Manufacturing Practices)

  • USP <797> (United States Pharmacopeia Chapter <797>)

  • JP 14th Edition (Japanese Pharmacopeia)

    • These standards provide a framework for ensuring that sterile products are manufactured in accordance with good manufacturing practices and regulatory requirements.

    Standard Compliance Requirements

    Compliance with standards is essential to ensure that sterile products meet the required quality and safety standards. Non-compliance can result in serious consequences, including product recalls, fines, and reputational damage.

    Industry sectors that require compliance with ISO 11737-2 standard include:

  • Pharmaceutical industry

  • Medical device industry

  • Biotechnology industry

    • Sterility testing is a critical component of the manufacturing process for sterile products. This type of testing ensures that products are free from microbial contamination, which can have serious consequences for patient safety.

    The ISO 11737-2 standard requires that sterility testing be conducted using methods that meet specific requirements, including:

  • Use of validated methods

  • Use of calibrated equipment

  • Documentation of testing results

    • Conducting sterility testing in accordance with the ISO 11737-2 standard provides several benefits, including:

  • Ensures product safety and quality

  • Meets regulatory requirements

  • Supports GMP compliance

  • Enhances customer confidence and trust

  • Facilitates international trade and market access

    • Failure to conduct sterility testing in accordance with the ISO 11737-2 standard can result in serious consequences, including:

  • Product recalls

  • Fines and penalties

  • Reputational damage

  • Loss of customer trust and confidence

    • The ISO 11737-2 standard specifies the requirements for sterility testing, including the methods used, equipment required, and documentation needed. The following steps are involved in conducting sterility testing:

    1. Sample preparation

    2. Testing using validated methods

    3. Calibration of equipment

    4. Documentation of testing results

    5. Validation of testing results

    The testing process involves several steps, including:

  • Sampling: Selecting a representative sample from the batch or lot.

  • Preparation: Preparing the sample for testing by removing any contaminants or debris.

  • Testing: Conducting sterility testing using validated methods and calibrated equipment.

  • Documentation: Recording and documenting all aspects of the testing process.

    • The ISO 11737-2 standard specifies that sterility testing should be conducted in accordance with one of two methods:

    1. Membrane filtration method

    2. Inoculation method

    Each method has specific requirements, including:

  • Use of validated filters or inoculants

  • Calibration of equipment

  • Documentation of testing results

    • The ISO 11737-2 standard also requires that sterility testing be conducted in accordance with good laboratory practices (GLPs), including:

  • Use of calibrated and validated equipment

  • Proper documentation of testing results

  • Maintenance of accurate records

    • Persuasive and Commercial Appeal

    In conclusion, the ISO 11737-2 standard provides a framework for ensuring that sterile products meet the required quality and safety standards. Compliance with this standard is essential to ensure product safety, quality, and regulatory compliance.

    Industry sectors that require compliance with ISO 11737-2 standard include pharmaceutical industry, medical device industry, and biotechnology industry. Non-compliance can result in serious consequences, including product recalls, fines, and reputational damage.

    The testing process involves several steps, including sampling, preparation, testing, calibration of equipment, documentation of testing results, and validation of testing results.

    In summary, the ISO 11737-2 standard provides a comprehensive framework for ensuring that sterile products meet the required quality and safety standards. Compliance with this standard is essential to ensure product safety, quality, and regulatory compliance.

    Appendix

    The following appendix provides additional information on the ISO 11737-2 standard, including:

  • Overview of the standard

  • Requirements for sterility testing

  • Methods used in sterility testing

  • Calibration of equipment

  • Documentation of testing results

    • This comprehensive guide has provided a detailed overview of the ISO 11737-2 standard and its requirements. By following this standard, industry sectors can ensure that sterile products meet the required quality and safety standards.

    References

    1. ISO 11737-2:2019 (E) - Sterilization of medical devices - Requirements for validation and routine control of a sterilization process for medical devices

    2. ASTM E2454-14: Standard Practice for Sterilization Validation

    3. EN 556-1:1997A1:2003: Sterilization by ionizing radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process

    4. TSE EN ISO 11140-1:2014: Sterilization of medical devices - Integrated routine tests - Part 1: General requirements

    By following this comprehensive guide and referencing the provided standards, industry sectors can ensure compliance with the ISO 11737-2 standard and maintain the quality and safety of sterile products.

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