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ep-2612-microbiological-examination-of-non-sterile-products-microbial-enumeration-tests
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 2.6.13 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 11138-4 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

EUROLABs Comprehensive Guide to EP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests

EP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests is a critical laboratory testing service that ensures the quality and safety of non-sterile products by detecting and enumerating microorganisms present in them. This test is governed by various international and national standards, which are outlined below:

  • ISO 11133:2006: Microbiology of food, water and animal feeding stuffs Preparation, incorporation, enumeration and storage of culture media and use of prepared media in the quality and sensitivity testing of laboratory equipment

  • ASTM E2757-11: Standard Practice for Microbiological Examination of Non-Sterile Pharmaceutical Products

  • EN 13726:2002: Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of basic hygiene conditions for chemical disinfection and antisepticisation

  • TSE 1175-2018: Microbiological examination of non-sterile pharmaceutical products

    • These standards establish the requirements for microbiological testing, including sampling, sample preparation, enumeration methods, and interpretation of results. They also outline the necessary equipment, reagents, and techniques to ensure accurate and reliable test results.

    Standard Development Organizations

    The development of these standards involves collaboration among various stakeholders, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations play a crucial role in maintaining the integrity and relevance of the standards. Their involvement ensures that the standards are up-to-date, comprehensive, and aligned with industry needs.

    Evolution of Standards

    Standards undergo periodic revisions to reflect changes in technology, scientific understanding, or regulatory requirements. This process involves:

  • Review of existing standards by technical committees

  • Identification of areas for improvement or revision

  • Development of new standards or updates to existing ones

    • For instance, ISO 11133:2006 was revised in 2020 to incorporate new testing methods and improved sensitivity.

    Standard Compliance Requirements

    Different industries have specific requirements for standard compliance:

  • Pharmaceutical industry: EP 2.6.12 is a mandatory requirement for the microbiological examination of non-sterile pharmaceutical products.

  • Cosmetics industry: EN 13726:2002 is often referenced in cosmetics regulations and guidelines.

  • Food industry: ISO 11133:2006 is widely used in food safety testing.

    • Non-compliance with these standards can result in regulatory issues, product recalls, or damage to reputation.

    Standard-Related Information

    Standard Title Reference

    --- --- ---

    ISO 11133:2006 Microbiology of food, water and animal feeding stuffs Preparation, incorporation, enumeration and storage of culture media 1

    ASTM E2757-11 Standard Practice for Microbiological Examination of Non-Sterile Pharmaceutical Products 2

    EN 13726:2002 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of basic hygiene conditions 3

    TSE 1175-2018 Microbiological examination of non-sterile pharmaceutical products 4

    EP 2.6.12 is essential for ensuring product safety and quality in various industries, including:

  • Pharmaceuticals: Non-sterile products may contain microorganisms that can affect their potency or cause contamination.

  • Cosmetics: Microbial growth can lead to spoilage, allergic reactions, or even infections.

  • Food industry: Contamination of food products with microorganisms can result in foodborne illnesses.

    • Business and Technical Reasons

    This test is required due to:

  • Regulatory compliance: EP 2.6.12 is a mandatory requirement for non-sterile pharmaceutical products.

  • Product safety: Microbial contamination can compromise product quality, leading to recalls or damaged reputation.

  • Risk assessment: Testing helps identify potential risks associated with microbiological contamination.

    • Consequences of Non-Performance

    Not performing EP 2.6.12 can lead to:

  • Regulatory issues and fines

  • Product recalls and damage to reputation

  • Safety risks for consumers and workers

    • Quality Assurance and Quality Control

    This test contributes significantly to quality assurance and control by:

  • Ensuring product safety and reliability

  • Detecting potential microbiological contamination

  • Providing valuable information on microbial growth and enumeration

    • Interpretation of Results

    Test results are evaluated based on predetermined criteria, including:

  • Microbial load (CFU/mL)

  • Type of microorganism detected

  • Presence of biofilms or other types of microbial contamination

    • This comprehensive evaluation enables the identification of potential issues and corrective actions.

    Additional Information

    Industry Regulatory Requirements

    --- ---

    Pharmaceuticals EP 2.6.12 is mandatory for non-sterile pharmaceutical products.

    Cosmetics EN 13726:2002 is often referenced in cosmetics regulations and guidelines.

    Food industry ISO 11133:2006 is widely used in food safety testing.

    EP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests

    This comprehensive guide has provided a detailed overview of the standard-related information, standard development organizations, evolution of standards, and compliance requirements for EP 2.6.12. By understanding the importance of this test and its role in ensuring product safety and quality, manufacturers can ensure regulatory compliance and minimize risks associated with microbiological contamination.

    Additional References

  • 1 ISO 11133:2006 Microbiology of food, water and animal feeding stuffs Preparation, incorporation, enumeration and storage of culture media.

  • 2 ASTM E2757-11 Standard Practice for Microbiological Examination of Non-Sterile Pharmaceutical Products.

  • 3 EN 13726:2002 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of basic hygiene conditions.

  • 4 TSE 1175-2018 Microbiological examination of non-sterile pharmaceutical products.

    • EUROLABs Services

    As a leading laboratory testing services provider, EUROLAB offers comprehensive solutions for microbiological testing, including EP 2.6.12. Our experienced team and state-of-the-art equipment ensure accurate and reliable test results, meeting the needs of various industries and regulatory requirements.

    Contact us today to learn more about our services and how we can support your quality control and assurance needs!

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