EUROLAB
ph-eur-2612-microbial-contamination-testing-of-non-sterile-products
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 11737-2 Sterility Assurance and Validation for Pharmaceutical ComponentsISO 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. 2.6.13 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 Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products Laboratory Testing Service Provided by Eurolab

Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products is a laboratory testing service that evaluates the presence and quantity of microorganisms in non-sterile products. This testing service is governed by various international and national standards, including:

  • ISO/TS 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation, test and validation of diagnostic microbiological culture media

  • ASTM E1799 - Standard Practice for Preparation of Diagnostic Culture Media

  • EN ISO 11133:2009 - Microbiology of the food chain Guidelines on preparation and production of culture media

  • TSE (Turkish Standards Institution) TS EN ISO 11133:2009

    • These standards outline the requirements for preparing, testing, and validating diagnostic microbiological culture media. They also provide guidelines for the preparation of non-sterile products for microbial contamination testing.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products is governed by various international and national regulations, including:

  • European Pharmacopoeia (Ph. Eur.)

  • US Food and Drug Administration (FDA) Guidelines for Pharmaceutical Quality

  • World Health Organization (WHO) Guidelines on Good Manufacturing Practices

    • These regulations outline the requirements for ensuring the quality, safety, and efficacy of non-sterile products.

    Standard Development Organizations

    Standard development organizations play a crucial role in the development and maintenance of standards related to Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products. These organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution and Update

    Standards related to Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products are subject to periodic review and update to ensure they remain relevant and effective. This process involves:

  • Monitoring industry developments and advancements

  • Conducting research and analysis

  • Consultation with stakeholders and experts

    • Standard Numbers and Scope

    The following standard numbers and scope are relevant to Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products:

  • ISO/TS 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation, test and validation of diagnostic microbiological culture media

    • Scope: Preparation, testing, and validation of diagnostic microbiological culture media for use in the analysis of non-sterile products.

  • ASTM E1799 - Standard Practice for Preparation of Diagnostic Culture Media

    • Scope: Preparation of diagnostic culture media for use in the analysis of non-sterile products.

    Industry-Specific Compliance Requirements

    Non-sterile product manufacturers must comply with specific standards and regulations depending on their industry. For example:

  • Pharmaceuticals: Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products is a mandatory testing service for pharmaceutical products.

  • Cosmetics: ISO/TS 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation, test and validation of diagnostic microbiological culture media is recommended for cosmetics manufacturers.

    • Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products testing is essential to ensure the quality, safety, and efficacy of non-sterile products. The business and technical reasons for conducting this test include:

  • Ensuring product quality: Microbial contamination can affect the quality and stability of non-sterile products.

  • Compliance with regulations: Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products is a mandatory testing service for pharmaceutical products.

  • Protecting consumer health: Microbial contamination can pose a risk to human health.

    • The consequences of not performing this test include:

  • Product recalls and recalls costs

  • Loss of customer confidence and trust

  • Financial losses due to product failure

    • Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products testing involves the following steps:

    1. Sample collection: Non-sterile products are collected from manufacturers.

    2. Preparation of culture media: Diagnostic microbiological culture media is prepared according to ISO/TS 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation, test and validation of diagnostic microbiological culture media.

    3. Inoculation and incubation: The non-sterile product is inoculated with the prepared culture medium and incubated at a specific temperature (usually 20C to 37C).

    4. Microbial enumeration: Microorganisms present in the non-sterile product are enumerated using standard microbiological techniques.

    Quality Control Measures

    Eurolab follows strict quality control measures to ensure accurate results, including:

  • Calibration and maintenance of equipment

  • Validation of diagnostic culture media

  • Training of laboratory personnel

    • Test Report and Certificate

    A comprehensive test report and certificate will be provided to clients upon completion of the testing service. The report includes details on the following:

  • Methodology used for testing

  • Results obtained from testing (including microbial enumeration)

  • Conclusion drawn from testing results

    • Please note that this is a general outline, and specific requirements may vary depending on client needs.

    Appendix

    Additional information and resources related to Ph. Eur. 2.6.12 Microbial Contamination Testing of Non-Sterile Products can be found in the following:

  • Eurolab website

  • ISO/TS 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation, test and validation of diagnostic microbiological culture media

  • ASTM E1799 - Standard Practice for Preparation of Diagnostic Culture Media

    • Please contact us for further information or to request a quote.

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