EUROLAB
ep-2613-microbiological-examination-of-non-sterile-products-test-for-specified-microorganisms
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 TestsFDA 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

Comprehensive Guide to EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms Laboratory Testing Service by Eurolab

The EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms laboratory testing service provided by Eurolab is governed by a multitude of international and national standards. These standards are designed to ensure the safety, quality, and efficacy of non-sterile products, which includes pharmaceuticals, cosmetics, food, and other related industries.

1.1 Relevant Standards

  • ISO 11133:2014 - Microbiology of food, water, and feeding stuffs -- Guidelines on preparation and production of culture media

  • ASTM E2553-13 - Standard Practice for Preparing the Environment for Testing Non-Sterile Products for Specified Microorganisms

  • EN 13624:2001 - Cosmetic products - Microbiological requirements

  • TSE (Turkish Standards Institution) 1435:2012 - Pharmaceutical preparations - Microbiological requirements

    • 1.2 Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), the European Committee for Standardization (CEN), and the Turkish Standards Institution (TSE) are some of the prominent standard development organizations that govern the EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms testing.

    1.3 Legal and Regulatory Framework

    The legal and regulatory framework surrounding this testing service is primarily driven by international and national standards, regulations, and directives. For instance:

  • The EUs Good Manufacturing Practice (GMP) guidelines mandate that non-sterile products be tested for specified microorganisms to ensure their safety and quality.

  • The US FDA requires manufacturers of pharmaceuticals and cosmetics to test their products for microbial contamination.

    • 1.4 International and National Standards

    The following international and national standards apply to the EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms testing:

  • ISO/TS 11133:2003 - Microbiology of food, water, and feeding stuffs -- General guidance on methods by sampling

  • EN 1231:2012 - Cosmetics - General safety requirements for products with a declared intended effect against micro-organisms

    • The EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms testing is essential for ensuring the safety and quality of non-sterile products.

    2.1 Business and Technical Reasons

    Conducting this test provides numerous business and technical reasons, including:

  • Ensuring compliance with regulatory requirements

  • Verifying product safety and efficacy

  • Protecting consumer health and well-being

  • Preventing contamination and spoilage

    • 2.2 Consequences of Not Performing the Test

    Failure to perform this test can result in serious consequences, such as:

  • Product recalls and financial losses

  • Damage to reputation and brand image

  • Legal and regulatory penalties

    • 2.3 Industries Requiring This Testing

    The following industries require the EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms testing:

  • Pharmaceuticals

  • Cosmetics

  • Food

  • Beverages

  • Personal care products

    • The EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms testing involves the following steps and procedures:

    3.1 Sample Preparation

    Samples are prepared by Eurolabs experienced personnel using sterile equipment and techniques to minimize contamination.

    3.2 Testing Parameters and Conditions

    The test is conducted under specific parameters and conditions, including temperature, humidity, pressure, and light.

    3.3 Measurement and Analysis Methods

    Eurolab uses state-of-the-art equipment and methods for measuring and analyzing the results, including:

  • Microbiological analysis

  • Spectrophotometry

    • The test results are documented and reported in a clear and concise manner.

    4.1 Report Format and Structure

    Eurolabs test reports follow a standardized format and structure, including:

  • Summary of test results

  • Methodology used

  • Results interpretation

  • Conclusion and recommendations

    • The EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms testing provides numerous benefits, including:

  • Ensuring product safety and efficacy

  • Protecting consumer health and well-being

  • Preventing contamination and spoilage

  • Compliance with regulatory requirements

    • Conclusion

    The EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms laboratory testing service provided by Eurolab is essential for ensuring the safety, quality, and efficacy of non-sterile products. This comprehensive guide has outlined the relevant standards, standard development organizations, legal and regulatory framework, international and national standards, business and technical reasons, consequences of not performing the test, industries requiring this testing, test conditions and methodology, test reporting and documentation, and benefits of performing this test.

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