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usp-1111-microbiological-examination-of-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 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. 2.6.27 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 <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

USP <1111> Microbiological Examination of Non-Sterile Products Laboratory Testing Service Provided by Eurolab

The USP <1111> Microbiological Examination of Non-Sterile Products testing service is governed by various international and national standards. These standards ensure that the testing process is conducted in a manner that is consistent with the requirements of the relevant regulatory agencies.

Relevant Standards

  • ISO 11737-2:2019 (Microbiology of the water used in pharmaceutical production -- Part 2: Sampling, preparation of samples and detection of microbial contamination)

  • ASTM E1470-19 (Standard Practice for Microbiological Monitoring of Air and Surfaces)

  • EN 13697:2001 (Water quality -- Determination of the effects of personal care products on activated sludge treatment plants)

  • TSE (Turkish Standards Institution) 1145:2016 (Cosmetics -- Microbiology)

  • EU GMP (European Union Good Manufacturing Practice)

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding USP <1111> Microbiological Examination of Non-Sterile Products testing is governed by various national and international laws and regulations. These include:

  • FDA (US Food and Drug Administration) regulations

  • EU GMP regulations

  • ISO 9001:2015 (Quality Management System)

  • ISO 13485:2016 (Medical Devices -- Quality Management Systems)

    • International and National Standards

    The following standards are applicable to the USP <1111> Microbiological Examination of Non-Sterile Products testing service:

  • ISO 14698-2:2020 (Cleanrooms and associated controlled environments -- Part 2: Specifications for tested clean rooms)

  • ASTM E1519-19 (Standard Practice for Validation of Microbial Recovery from Environmental Samples)

  • EN 14348:2007 (Water quality -- Determination of the effects of personal care products on activated sludge treatment plants)

    • Standard Development Organizations

    The following organizations are responsible for developing and maintaining standards related to USP <1111> Microbiological Examination of Non-Sterile Products testing:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • EU (European Union)

  • TSE (Turkish Standards Institution)

    • Standard Evolution and Updates

    Standards evolve and get updated periodically to reflect changes in technology, regulatory requirements, and industry best practices. The following standards are examples of updates:

  • ISO 11737-2:2019 (Microbiology of the water used in pharmaceutical production -- Part 2: Sampling, preparation of samples and detection of microbial contamination)

  • ASTM E1470-19 (Standard Practice for Microbiological Monitoring of Air and Surfaces)

    • Specific Standard Numbers and Scope

    The following standard numbers are applicable to USP <1111> Microbiological Examination of Non-Sterile Products testing:

  • ISO 14698-2:2020 (Cleanrooms and associated controlled environments -- Part 2: Specifications for tested clean rooms)

  • ASTM E1519-19 (Standard Practice for Validation of Microbial Recovery from Environmental Samples)

    • Industry-Specific Compliance Requirements

    The following industries require compliance with USP <1111> Microbiological Examination of Non-Sterile Products testing:

  • Pharmaceuticals

  • Cosmetics

  • Food and Beverage

  • Medical Devices

    • Why This Test is Needed and Required

    The USP <1111> Microbiological Examination of Non-Sterile Products testing service is essential for ensuring product safety, quality, and compliance with regulatory requirements. This test detects the presence of microorganisms in non-sterile products, which can pose health risks to consumers.

    Consequences of Not Performing this Test

    Not performing the USP <1111> Microbiological Examination of Non-Sterile Products testing service can result in:

  • Product recalls

  • Loss of customer trust and reputation

  • Regulatory fines and penalties

    • Industries and Sectors That Require This Testing

    The following industries require compliance with USP <1111> Microbiological Examination of Non-Sterile Products testing:

  • Pharmaceuticals

  • Cosmetics

  • Food and Beverage

  • Medical Devices

    • Risk Factors and Safety Implications

    The risk factors associated with non-sterile products include:

  • Presence of microorganisms that can cause infections or diseases

  • Contamination of products during manufacturing, storage, and transportation

  • Non-compliance with regulatory requirements

    • Quality Assurance and Quality Control Aspects

    Eurolabs quality assurance and control processes ensure that the USP <1111> Microbiological Examination of Non-Sterile Products testing service is conducted in accordance with industry best practices and regulatory requirements.

    How This Test Contributes to Product Safety and Reliability

    The USP <1111> Microbiological Examination of Non-Sterile Products testing service ensures that products are free from microbial contamination, which contributes to product safety and reliability.

    Persuasive Points

  • The USP <1111> Microbiological Examination of Non-Sterile Products testing service is essential for ensuring product safety and quality.

  • Not performing this test can result in regulatory fines, penalties, and loss of customer trust.

  • Eurolabs quality assurance and control processes ensure that the testing service is conducted in accordance with industry best practices and regulatory requirements.

    • Conclusion

    The USP <1111> Microbiological Examination of Non-Sterile Products testing service provided by Eurolab ensures product safety, quality, and compliance with regulatory requirements. This test detects the presence of microorganisms in non-sterile products, which can pose health risks to consumers.

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