EUROLAB
ph-eur-2627-bacterial-endotoxin-testing-in-parenteral-drugs
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. 2.6.14 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. 2.6.30 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. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs Laboratory Testing Service Provided by Eurolab

Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs is a laboratory test that measures the presence of bacterial endotoxins in parenteral drugs, which are medications administered via injection or infusion. This testing service is governed by various international and national standards, including:

  • ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for irritation

  • ASTM E2388-13 Standard Test Method for Determination of Endotoxins in Reagents for Use in Coupled Enzyme Assays

  • EN 14338:2005A1:2009 Medical devices. Biological evaluation of medical devices Part 4: Evaluation of biological properties related to the safety and performance of a medical device

  • TSE (Turkish Standards Institution) TS EN ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for irritation

  • USP <85> Bacterial Endotoxins Test

    • These standards outline the requirements for testing parenteral drugs for bacterial endotoxins, including sample preparation, testing equipment, and reporting of results. The legal and regulatory framework surrounding this testing service is governed by national and international regulations, such as:

  • European Unions (EU) Medical Device Regulation (MDR)

  • US Food and Drug Administrations (FDA) regulations

  • International Organization for Standardization (ISO) standards

    • Standard development organizations, such as ISO, ASTM, and EN, play a crucial role in developing and maintaining these standards. These organizations collaborate with experts from various industries to ensure that the standards are relevant, up-to-date, and meet the needs of the industry.

    Standards evolve and get updated regularly to reflect new technologies, scientific advancements, and changes in regulatory requirements. For example, the ISO 10993-11 standard was revised in 2017 to include new testing methods and requirements for evaluating biological properties related to medical device safety and performance.

    The following are specific standard numbers and their scope:

  • ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for irritation

    • Scope: This document specifies the tests for irritation, which include bacterial endotoxin testing in parenteral drugs.

  • ASTM E2388-13 Standard Test Method for Determination of Endotoxins in Reagents for Use in Coupled Enzyme Assays

    • Scope: This standard describes a method for determining endotoxins in reagents used in coupled enzyme assays.

    Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs is essential for ensuring the safety and efficacy of parenteral drugs. The business and technical reasons for conducting this testing include:

  • Ensuring compliance with regulatory requirements

  • Reducing the risk of product contamination and associated recalls

  • Enhancing product quality and reliability

  • Improving customer confidence and trust

  • Supporting innovation and research development

    • Consequences of not performing this test can be severe, including:

  • Regulatory non-compliance and associated penalties

  • Product contamination and associated recalls

  • Loss of customer confidence and trust

  • Negative impact on business reputation and revenue

    • Industries that require Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs include:

  • Pharmaceutical manufacturing

  • Medical device manufacturing

  • Biotechnology

  • Research institutions

    • Risk factors associated with this testing include:

  • Contamination of parenteral drugs with bacterial endotoxins

  • Inadequate sample preparation and testing procedures

  • Insufficient quality control measures during testing

    • Quality assurance and quality control aspects are critical in Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs, including:

  • Sample preparation and testing procedures

  • Equipment calibration and maintenance

  • Quality control measures during testing

  • Data collection and recording procedures

    • This test contributes to product safety and reliability by ensuring that parenteral drugs are free from bacterial endotoxins.

    Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs involves the following steps:

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

    2. Testing equipment: A validated testing instrument, such as a LAL (Limulus Amoebocyte Lysate) or Chromogenic assay system, is used.

    3. Testing environment: The testing environment must meet specific temperature and humidity requirements.

    4. Sample analysis: The sample is analyzed using the chosen testing method.

    5. Data collection and recording: Results are recorded and documented.

    The following are critical aspects of Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs:

  • Equipment calibration and maintenance

  • Quality control measures during testing

  • Sample preparation and testing procedures

    • Comprehensive Guide to Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs Laboratory Testing Service Provided by Eurolab

    This guide has provided a comprehensive overview of the standard-related information, standard requirements and needs, and test conditions and methodology for Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs.

    The importance of this testing service cannot be overstated, as it ensures the safety and efficacy of parenteral drugs by detecting bacterial endotoxins.

    Conclusion

    Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs is a critical laboratory test that measures the presence of bacterial endotoxins in parenteral drugs. This testing service is governed by various international and national standards, including ISO 10993-11:2017 and ASTM E2388-13.

    The consequences of not performing this test can be severe, including regulatory non-compliance, product contamination, loss of customer confidence, and negative impact on business reputation and revenue.

    Industries that require Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs include pharmaceutical manufacturing, medical device manufacturing, biotechnology, and research institutions.

    This guide has provided a comprehensive overview of the standard-related information, standard requirements and needs, and test conditions and methodology for Ph. Eur. 2.6.27 Bacterial Endotoxin Testing in Parenteral Drugs.

    References

  • ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for irritation

  • ASTM E2388-13 Standard Test Method for Determination of Endotoxins in Reagents for Use in Coupled Enzyme Assays

  • EN 14338:2005A1:2009 Medical devices. Biological evaluation of medical devices Part 4: Evaluation of biological properties related to the safety and performance of a medical device

  • TSE (Turkish Standards Institution) TS EN ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for irritation

  • USP <85> Bacterial Endotoxins Test

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