EUROLAB
ph-eur-2613-detection-of-clostridia-in-parenteral-solutions
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. 2.6.12 Microbial Contamination Testing of Non-Sterile ProductsPh. 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

Ph. Eur. 2.6.13 Detection of Clostridia in Parenteral Solutions: Eurolabs Laboratory Testing Service

Standard-Related Information

The detection of Clostridia in parenteral solutions is a critical aspect of ensuring the safety and quality of injectable products. The European Pharmacopoeia (Ph. Eur.) standard 2.6.13 provides the guidelines for detecting Clostridia in parenteral solutions, which are essential for pharmaceutical manufacturers, regulatory authorities, and healthcare professionals.

Overview of Standards

The standards governing Ph. Eur. 2.6.13 Detection of Clostridia in Parenteral Solutions testing include:

  • European Pharmacopoeia (Ph. Eur.) standard 2.6.13

  • International Organization for Standardization (ISO) standards: ISO 11133, ISO 13485, and ISO 9001

  • United States Pharmacopeia (USP) standard <1227>

  • Japanese Pharmacopoeia (JP) standard 12.11

    • Legal and Regulatory Framework

    The detection of Clostridia in parenteral solutions is regulated by various laws and regulations, including:

  • European Union (EU) directives: EU GMP (Annex 1), EU GDP (Annex 2)

  • US FDA regulations: 21 CFR Part 211

  • Japanese Ministry of Health, Labour and Welfare (MHLW) guidelines

    • International and National Standards

    The following international and national standards apply to Ph. Eur. 2.6.13 Detection of Clostridia in Parenteral Solutions testing:

  • ISO 11133:2009(E): Microbiology - General requirements for the detection of adventitious agents

  • ISO 13485:2016: Medical devices -- Quality management systems -- Requirements for regulatory purposes

  • USP <1227>: Bacterial endotoxins test

  • JP 12.11: Detection of bacterial contamination

    • Standard Development Organizations

    The standard development organizations responsible for developing and maintaining the standards related to Ph. Eur. 2.6.13 Detection of Clostridia in Parenteral Solutions testing include:

  • European Pharmacopoeia Commission (Ph. Eur.)

  • International Organization for Standardization (ISO)

  • United States Pharmacopeial Convention (USP)

  • Japanese Pharmacopoeia Commission (JP)

    • How Standards Evolve and Get Updated

    Standards evolve through a continuous process of review, revision, and update to reflect changes in technology, regulations, and scientific knowledge. This involves:

  • Monitoring regulatory updates

  • Participating in standard development committees

  • Conducting research and testing

  • Reviewing and revising standards

    • Standard Numbers and Scope

    The following are the relevant standard numbers and their scope:

    Standard Number Title Scope

    --- --- ---

    Ph. Eur. 2.6.13 Detection of Clostridia in parenteral solutions Detection of Clostridia in parenteral solutions using a selective enrichment culture method

    ISO 11133:2009(E) Microbiology - General requirements for the detection of adventitious agents General requirements for detecting adventitious agents, including bacteria, viruses, and mycoplasma

    USP <1227> Bacterial endotoxins test Detection of bacterial endotoxins in parenteral solutions using a chromogenic substrate

    Standard Compliance Requirements

    The compliance requirements for different industries are as follows:

  • Pharmaceutical industry: Ph. Eur. 2.6.13, ISO 11133:2009(E), USP <1227>

  • Medical device industry: ISO 13485:2016

  • Biotechnology industry: Ph. Eur. 2.6.13, ISO 11133:2009(E)

    • Standard-Related Information Conclusion

    The detection of Clostridia in parenteral solutions is a critical aspect of ensuring the safety and quality of injectable products. The relevant standards are governed by the European Pharmacopoeia (Ph. Eur.), International Organization for Standardization (ISO), United States Pharmacopeial Convention (USP), and Japanese Pharmacopoeia Commission (JP). Compliance with these standards is essential for pharmaceutical manufacturers, regulatory authorities, and healthcare professionals.

    Standard Requirements and Needs

    The detection of Clostridia in parenteral solutions is necessary due to the following reasons:

  • Quality assurance: The detection of Clostridia ensures that parenteral solutions are free from bacterial contamination.

  • Regulatory compliance: Compliance with Ph. Eur. 2.6.13, ISO 11133:2009(E), and USP <1227> is required for regulatory approval.

  • Product safety: The detection of Clostridia ensures the safety of injectable products.

    • Business and Technical Reasons

    The business and technical reasons for detecting Clostridia in parenteral solutions include:

  • Reduced risk of contamination: Detection of Clostridia reduces the risk of bacterial contamination, which can lead to adverse reactions or product recalls.

  • Improved quality: Detection of Clostridia ensures that parenteral solutions meet regulatory requirements for quality.

    • Regulatory Compliance

    Compliance with Ph. Eur. 2.6.13, ISO 11133:2009(E), and USP <1227> is essential for regulatory approval. Non-compliance can result in:

  • Product recalls

  • Adverse reactions

  • Loss of reputation

    • Detection Methods

    The detection methods used to detect Clostridia in parenteral solutions include:

  • Selective enrichment culture method: Ph. Eur. 2.6.13

  • Chromogenic substrate test: USP <1227>

    • Standard Requirements and Needs Conclusion

    The detection of Clostridia in parenteral solutions is essential for ensuring product safety, quality, and regulatory compliance.

    Conclusion

    Eurolabs laboratory testing service provides comprehensive detection services for Clostridia in parenteral solutions. Our expertise ensures that your products meet regulatory requirements and are safe for use by patients.

    In the following sections, we will provide an overview of Eurolabs laboratory testing services, our quality management system, and our commitment to customer satisfaction.

    Eurolab Laboratory Testing Services

    Our laboratory testing services include:

  • Detection of Clostridia: Ph. Eur. 2.6.13

  • Bacterial endotoxins test: USP <1227>

  • Sterility testing: ISO 11133:2009(E)

    • Quality Management System

    Eurolabs quality management system is based on the following standards:

  • ISO 13485:2016

  • ISO 9001:2015

    • Our quality management system ensures that our laboratory testing services meet regulatory requirements and are compliant with international standards.

    Commitment to Customer Satisfaction

    At Eurolab, we are committed to providing exceptional customer service. Our team of experts is dedicated to ensuring that your products meet regulatory requirements and are safe for use by patients.

    In conclusion, Eurolabs laboratory testing service provides comprehensive detection services for Clostridia in parenteral solutions. Our expertise ensures that your products meet regulatory requirements and are safe for use by patients.

    Please contact us for more information on our laboratory testing services and to discuss your specific needs.

    Appendix

    The following is an appendix containing additional information related to Ph. Eur. 2.6.13 Detection of Clostridia in Parenteral Solutions:

  • List of approved culture media

  • Guide to interpreting test results

  • References to relevant standards

    • Please note that this is a comprehensive guide, and you should refer to the relevant standards for specific requirements.

    ---

    We hope this comprehensive guide has provided you with a thorough understanding of Ph. Eur. 2.6.13 Detection of Clostridia in Parenteral Solutions testing services. If you have any further questions or would like to discuss your specific needs, please do not hesitate to contact us.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers