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iso-18415-detection-of-pathogenic-microorganisms-in-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 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. 2.6.27 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 ISO 18415 Detection of Pathogenic Microorganisms in Non-Sterile Products Laboratory Testing Service Provided by Eurolab

ISO 18415 is an international standard that provides guidelines for the detection of pathogenic microorganisms in non-sterile products. The standard is developed and maintained by the International Organization for Standardization (ISO) and is widely recognized as a benchmark for laboratory testing services.

1.1 Relevant Standards

The relevant standards governing ISO 18415 are:

  • ISO 18415:2017 Detection of pathogenic microorganisms in non-sterile products

  • ASTM E2196-13 Standard Test Method for Evaluation of Resistance of Materials to Fungi

  • EN 12096:2004 Laboratory testing - Measurement of the antimicrobial activity of chemical disinfectants and antiseptics

  • TSE (Turkish Standards Institution) EN ISO 18415:2017

    • These standards specify the requirements for laboratory testing, including sample preparation, testing parameters, and reporting.

    1.2 Legal and Regulatory Framework

    The legal and regulatory framework surrounding this testing service is governed by various national and international regulations, including:

  • EU Biocidal Products Regulation (EU) No 528/2012

  • US EPA 40 CFR Part 156: Registration of Pesticide Active Ingredients and Pesticide Chemicals

  • Canada Pest Management Regulatory Agency (PMRA)

  • Australia Department of Health

    • These regulations require manufacturers to ensure their products meet specific safety and performance standards, including the detection of pathogenic microorganisms.

    1.3 International and National Standards

    The international and national standards applicable to this laboratory test are:

  • ISO 18415:2017

  • ASTM E2196-13

  • EN 12096:2004

  • TSE (Turkish Standards Institution) EN ISO 18415:2017

    • These standards provide a framework for laboratory testing, including sampling, testing parameters, and reporting.

    1.4 Standard Development Organizations

    Standard development organizations play a crucial role in developing and maintaining standards. The main standard development organizations involved in this field are:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations ensure that standards are developed, maintained, and updated regularly to reflect the latest scientific knowledge and regulatory requirements.

    1.5 Evolution of Standards

    Standards evolve over time to reflect changes in technology, science, and regulations. The evolution of ISO 18415 is an ongoing process, with updates and revisions made as necessary to ensure that the standard remains relevant and effective.

    ISO 18415 detection of pathogenic microorganisms in non-sterile products testing is required for various industries, including:

  • Cosmetics

  • Pharmaceuticals

  • Food processing

  • Beverages

  • Personal care products

    • This test is necessary to ensure that products meet specific safety and performance standards, including the detection of pathogenic microorganisms.

    2.1 Business and Technical Reasons

    The business and technical reasons for conducting ISO 18415 testing include:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements

  • Maintaining consumer trust and confidence

  • Protecting brand reputation

    • Failing to conduct this test can result in serious consequences, including product recalls, lawsuits, and damage to reputation.

    2.2 Consequences of Not Performing This Test

    The consequences of not performing ISO 18415 testing include:

  • Product contamination and safety risks

  • Regulatory non-compliance and fines

  • Damage to brand reputation and consumer trust

  • Increased costs for product recalls and repairs

    • The test conditions and methodology for ISO 18415 detection of pathogenic microorganisms in non-sterile products are as follows:

  • Sampling: Sampling is carried out according to the relevant standard, including sample size, collection, and storage.

  • Testing equipment and instruments: The testing equipment and instruments used include:

    • Microbiological testing equipment (e.g., microbial growth medium, incubators)

    Analytical instruments (e.g., spectrophotometers, gas chromatographs)

    Laboratory information management system (LIMS) software

  • Testing environment requirements: The testing environment requirements include:

    • Temperature control (e.g., incubators, refrigerators)

    Humidity control (e.g., humidifiers, dehumidifiers)

    Pressure control (e.g., vacuum chambers, pressure vessels)

  • Sample preparation procedures: Sample preparation procedures involve:

    • Homogenization

    Sterilization

    Dilution and serial dilution

  • Testing parameters and conditions: The testing parameters and conditions include:

    • Temperature (e.g., 25C, 37C)

    Time (e.g., 24 hours, 72 hours)

    pH (e.g., neutral, acidic)

  • Reporting: Reporting involves providing a comprehensive report of the test results, including:

    • Test methodology

    Sample characteristics

    Results and conclusions

    4. Conclusion

    In conclusion, ISO 18415 detection of pathogenic microorganisms in non-sterile products is a critical laboratory testing service that ensures product safety and efficacy. The standard provides guidelines for sampling, testing parameters, and reporting, while the relevant national and international regulations govern the legal and regulatory framework.

    By understanding the standard requirements and needs, test conditions and methodology, and consequences of not performing this test, manufacturers can ensure their products meet specific safety and performance standards, including the detection of pathogenic microorganisms.

    5. Recommendation

    We recommend that manufacturers conduct ISO 18415 detection of pathogenic microorganisms in non-sterile products testing to ensure product safety and efficacy, meet regulatory requirements, maintain consumer trust and confidence, and protect brand reputation.

    For more information on this laboratory testing service, please contact Eurolab at insert contact information.

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