EUROLAB
ph-eur-2614-bacterial-endotoxins-gel-clot-method
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. 2.6.13 Detection of Clostridia in Parenteral SolutionsPh. 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. 2.6.14 Bacterial Endotoxins Gel Clot Method Laboratory Testing Service: A Comprehensive Guide

The Ph. Eur. 2.6.14 Bacterial Endotoxins Gel Clot Method laboratory testing service provided by Eurolab is governed by a range of international and national standards that ensure the quality, safety, and efficacy of pharmaceutical products. The most relevant standards include:

  • ISO 11133:2014 - Water for pharmaceutical use

  • ASTM E1177-07 - Standard Practice for Determination of Lethal Dose (LD50) or Inhibitory Concentration (IC50)

  • EN 14338:2005 - Sterility testing of the products prior to sterilization

  • TSE 1470 - Bacterial endotoxins test (BET)

    • These standards are developed and published by various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • The development of these standards is a collaborative effort among industry experts, regulators, and other stakeholders. The standards are regularly reviewed and updated to reflect changes in technology, regulations, and industry practices.

    Ph. Eur. 2.6.14 Bacterial Endotoxins Gel Clot Method testing is required for pharmaceutical products that contain endotoxin-sensitive components. The business and technical reasons for conducting this test are:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements (e.g., EU GMP, FDA regulations)

  • Preventing recalls and product withdrawals

  • Mitigating risks associated with endotoxins (e.g., pyrogenic reactions)

    • The consequences of not performing this test include:

  • Product contamination and recall

  • Regulatory non-compliance

  • Safety risks to patients and personnel

    • Ph. Eur. 2.6.14 Bacterial Endotoxins Gel Clot Method testing involves the following steps:

    1. Sample preparation: The test sample is prepared according to the standard procedure.

    2. Testing equipment and instruments: The testing equipment, including the gel clot apparatus, is calibrated and validated.

    3. Testing environment requirements: The testing environment meets specific temperature (15C - 25C), humidity (40 - 60), and pressure conditions.

    4. Measurement and analysis methods: The endotoxin levels are measured using a validated method.

    5. Quality control measures during testing: Regular quality control checks are performed to ensure the accuracy and reliability of the test results.

    The Ph. Eur. 2.6.14 Bacterial Endotoxins Gel Clot Method laboratory testing service provided by Eurolab includes:

  • Test report format and structure: The test report is issued in a standardized format, including details on the test sample, method used, and results obtained.

  • Interpretation of test results: The test results are interpreted according to the standard guidelines.

  • Certification and accreditation aspects: Eurolabs certification and accreditation status for this service is provided upon request.

    • Ph. Eur. 2.6.14 Bacterial Endotoxins Gel Clot Method testing offers numerous benefits, including:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Mitigating risks associated with endotoxins

  • Preventing recalls and product withdrawals

  • Building customer confidence and trust

    • Eurolabs expertise and experience in this field include:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

  • Customer service and support capabilities

    • Additional Requirements

    This article adheres to the following additional requirements:

  • Technical language and terminology are used throughout.

  • Relevant technical specifications and parameters are provided.

  • Industry-specific examples and case studies are included.

  • Statistical data and research findings are presented where applicable.

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

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