EUROLAB
ph-eur-261-sterility-testing-for-finished-pharmaceutical-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. 2.6.11 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 Eurolabs Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products Laboratory Testing Service

Standard-Related Information

Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products is a critical laboratory test that ensures the sterility of pharmaceutical products before they are released to the market. This testing service is governed by various international and national standards, which are discussed below.

International Standards

  • ISO 11137:2006 (now superseded by ISO 11137-1:2017 and ISO 11137-2:2018) specifies the requirements for sterility testing of medical devices and pharmaceutical products.

  • ASTM E1199-10 (Reapproved 2015) provides guidelines for sterility testing of medical devices and pharmaceutical products.

    • National Standards

  • EN ISO 11737-1:2012 and EN ISO 11737-2:2008 specify the requirements for sterility testing of medical devices and pharmaceutical products in Europe.

  • TSE (Turkish Standard Institution) TR ISO 11137-1:2017 and TR ISO 11137-2:2018 are used in Turkey.

    • Standard Development Organizations

    The development of standards is a collaborative effort between standard development organizations, such as:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standard Institution (TSE)

    • These organizations work together to ensure that international and national standards are harmonized.

    Standard Evolution and Updates

    Standards evolve and get updated as new technologies, methods, or requirements emerge. The following table shows the evolution of Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products:

    Standard Year Description

    --- --- ---

    ISO 11137:2006 2006 Specifies the requirements for sterility testing of medical devices and pharmaceutical products.

    ISO 11137-1:2017 2017 Updates the requirements for sterility testing of medical devices and pharmaceutical products.

    ISO 11137-2:2018 2018 Provides guidelines for sterility testing of medical devices and pharmaceutical products.

    Standard Compliance Requirements

    Pharmaceutical manufacturers must comply with relevant standards to ensure that their products meet regulatory requirements.

    Industry-Specific Examples and Case Studies

  • A pharmaceutical company manufactures injectable solutions, which require sterility testing before release.

  • A medical device manufacturer produces implantable devices, which also need sterility testing before release.

    • Standard-Related Risks and Consequences

    Failure to comply with Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products can result in:

  • Product recalls

  • Loss of reputation

  • Financial penalties

    • Business and Technical Reasons for Conducting the Test

    Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products is essential to ensure that pharmaceutical products are safe for use by patients.

    Consequences of Not Performing the Test

    Not performing the test can lead to:

  • Patient harm or injury

  • Product recalls

  • Financial losses

    • Industries and Sectors Requiring the Test

    Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products is required by:

  • Pharmaceuticals

  • Medical devices

  • Biotechnology

    • Risk Factors and Safety Implications

    The test identifies potential sterility issues, which can affect product safety.

    Quality Assurance and Quality Control Aspects

    Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products contributes to quality assurance and control by ensuring that products meet regulatory requirements.

    Competitive Advantages of Having the Test Performed

    Performing Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products provides:

  • Regulatory compliance

  • Quality assurance

  • Competitive advantage

    • Cost-Benefit Analysis of Performing the Test

    The benefits of performing Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products far outweigh the costs.

    Test Conditions and Methodology

    Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products involves:

  • Sample preparation

  • Incubation

  • Observation

    • Testing Equipment and Instruments Used

    The following equipment is used to perform Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products:

  • Autoclaves

  • Sterilization chambers

  • Microscopes

    • Testing Environment Requirements

    Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products requires a controlled environment, including:

  • Temperature control

  • Humidity control

  • Pressure control

    • Sample Preparation Procedures

    Samples are prepared according to ISO 11137-1:2017 and ISO 11137-2:2018 guidelines.

    Incubation and Observation

    The test involves incubating samples at 20-25C for 14 days, followed by observation using a microscope.

    Reporting and Record Keeping

    Results are reported and recorded in accordance with regulatory requirements.

    Test Conclusion

    Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products is an essential laboratory test that ensures the sterility of pharmaceutical products before release to the market.

    Eurolabs Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products Laboratory Testing Service

    Eurolabs Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products laboratory testing service is designed to meet regulatory requirements and ensure product safety.

    Conclusion

    Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products is a critical laboratory test that ensures the sterility of pharmaceutical products before release to the market. Eurolabs Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products laboratory testing service provides high-quality results, ensuring regulatory compliance and product safety.

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    Eurolabs Mission Statement

    At Eurolab, we are committed to providing high-quality laboratory testing services that meet regulatory requirements and ensure product safety.

    Contact Us

    For more information about Ph. Eur. 2.6.1 Sterility Testing for Finished Pharmaceutical Products or our laboratory testing service, please contact us at infoeurolab.com(mailto:infoeurolab.com) or 44 (0)20 7183 8888.

    References

    1. ISO 11137-1:2017.

    2. ISO 11137-2:2018.

    3. ASTM E1199-10 (Reapproved 2015).

    4. EN ISO 11737-1:2012 and EN ISO 11737-2:2008.

    5. TR ISO 11137-1:2017 and TR ISO 11137-2:2018.

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