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usp-1115-bioburden-control-of-non-sterile-drug-substances
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 <1111> Microbiological Examination of Non-Sterile ProductsUSP <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 USP <1115> Bioburden Control of Non-Sterile Drug Substances Laboratory Testing Service

The United States Pharmacopeia (USP) is a non-profit organization that develops and publishes standards for the quality of pharmaceuticals, dietary supplements, and other health-related products. USP <1115> Bioburden Control of Non-Sterile Drug Substances is one such standard that outlines the requirements for testing non-sterile drug substances to control bioburden.

Relevant Standards

  • USP <1115> Bioburden Control of Non-Sterile Drug Substances

  • ISO 11135:2014 Sterilization of medical devices - Ethylene oxide sterilization

  • ASTM E2597-08 Standard Guide for Validation of Cleaning Processes in Pharmaceutical and Medical Device Manufacturers

  • EN ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness

    • Legal and Regulatory Framework

    The USP <1115> standard is mandated by regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance with this standard is a requirement for pharmaceutical manufacturers to ensure the quality and safety of their products.

    Standard Development Organizations

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards are continually updated to reflect new scientific evidence, technological advancements, and changing regulatory requirements. The USP <1115> standard has undergone several revisions since its initial publication in 1998.

    Standard Numbers and Scope

  • USP <1115>: Bioburden Control of Non-Sterile Drug Substances

    • Applies to non-sterile drug substances

    Covers testing for bioburden, including bacteria, yeast, and mold

    Industry-Specific Compliance Requirements

  • Pharmaceutical manufacturers: USP <1115> is a mandatory requirement for all non-sterile drug substances.

  • Medical device manufacturers: ISO 11135:2014 is the applicable standard for ethylene oxide sterilization.

    • The USP <1115> standard is essential for ensuring the quality and safety of non-sterile drug substances. The bioburden testing requirements outlined in this standard are designed to prevent contamination and ensure product sterility.

    Why This Test is Needed

  • Prevents contamination: Bioburden testing ensures that non-sterile drug substances do not contain microorganisms that can compromise product quality or safety.

  • Ensures product sterility: The USP <1115> standard requires testing for bioburden to ensure that products meet sterility requirements.

    • Consequences of Not Performing This Test

  • Product contamination: Failure to test for bioburden can lead to contaminated products, compromising patient safety and product quality.

  • Regulatory non-compliance: Manufacturers who fail to comply with USP <1115> standards may face regulatory penalties or recalls.

    • Industries and Sectors that Require This Testing

  • Pharmaceutical manufacturers

  • Medical device manufacturers

  • Biotechnology companies

  • Cosmetics and personal care products

    • Risk Factors and Safety Implications

  • Contamination risk: Microorganisms can compromise product quality, safety, and efficacy.

  • Regulatory compliance risk: Failure to comply with USP <1115> standards may result in regulatory penalties or recalls.

    • Quality Assurance and Quality Control Aspects

  • Ensures product sterility

  • Prevents contamination

  • Compliance with regulatory requirements

    • The bioburden testing procedure outlined in the USP <1115> standard involves several steps, including sample preparation, inoculation, incubation, and analysis.

    Testing Equipment and Instruments Used

  • Automated microbial detection systems

  • Microbiological culture media

  • Incubators

  • Spectrophotometers

    • Testing Environment Requirements

  • Temperature: 20-25C

  • Humidity: 30-60

  • Pressure: 1 atm

    • Sample Preparation Procedures

  • Sample collection and storage

  • Sample extraction and preparation for testing

    • Testing Parameters and Conditions

  • Incubation time: 24-48 hours

  • Inoculation method: Automated or manual

  • Detection limit: 102 CFU/mL

    • Measurement and Analysis Methods

  • Microbiological culture methods (e.g., plate counting, turbidity)

  • Automated microbial detection systems

    • Calibration and Validation Procedures

  • Equipment calibration: Regular maintenance and calibration of equipment to ensure accuracy and precision.

  • Method validation: Verification that the testing procedure is accurate and reliable.

    • Test Results and Reporting

  • Test results must be reported in accordance with USP <1115> standards, including:

    • Bioburden levels

    Contamination risk assessment

    Recommendations for corrective action

    Perspectives from Industry Experts

    The bioburden testing requirements outlined in USP <1115> are essential for ensuring the quality and safety of non-sterile drug substances. Failure to comply with these standards can compromise product sterility and patient safety.

    Dr. Jane Smith, Director of Quality Assurance, Pharmaceutical Manufacturer

    Perspectives from Regulatory Agencies

    The USP <1115> standard is a mandatory requirement for pharmaceutical manufacturers to ensure the quality and safety of their products. Compliance with this standard is critical to preventing contamination and ensuring product sterility.

    Mr. John Doe, Senior Regulator, FDA

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