EUROLAB
usp-71-sterility-test-for-parenteral-drug-products
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical Products

USP <71> Sterility Test for Parenteral Drug Products Laboratory Testing Service

EUROLABs Expertise and Capabilities

Standard-Related Information

The USP <71> Sterility Test for Parenteral Drug Products is a crucial laboratory testing service that ensures the sterility of parenteral drug products. This test is governed by various international and national standards, including:

  • ISO 11137 (Sterilization of Health Care Products - Radiation)

  • ASTM F2103 (Standard Test Method for Sterility Testing)

  • EN 556-1 (Sterilization indicators in medical applications)

  • TSE (Turkish Standards Institution) TS EN 556-1

    • These standards provide a framework for the development, implementation, and validation of sterilization processes. They also specify requirements for testing equipment, sampling procedures, and data analysis.

    The regulatory framework surrounding this testing service is provided by:

  • The US Food and Drug Administration (FDA)

  • The European Medicines Agency (EMA)

  • The World Health Organization (WHO)

    • These regulatory bodies set forth guidelines and regulations for the development, manufacture, and testing of parenteral drug products, including sterilization requirements.

    Standard Requirements and Needs

    The USP <71> Sterility Test for Parenteral Drug Products is necessary to ensure product safety and efficacy. This test helps to prevent contamination and ensures that parenteral drug products meet sterility standards.

    Business and technical reasons for conducting this test include:

  • Prevention of contamination and microbial growth

  • Ensuring compliance with regulatory requirements

  • Maintaining product quality and consistency

  • Avoiding costly recalls and reputational damage

    • The consequences of not performing this test include:

  • Product contamination and potential harm to patients

  • Regulatory non-compliance and potential fines

  • Loss of customer confidence and market share

    • Industries that require this testing service include:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Medical device manufacturers

  • Contract research organizations (CROs) and contract manufacturing organizations (CMOs)

    • Risk factors and safety implications associated with this test include:

  • Contamination risk to patients and personnel

  • Potential for product recall and reputational damage

  • Regulatory non-compliance and fines

    • Quality assurance and quality control aspects of this test include:

  • Validation and verification procedures

  • Equipment calibration and maintenance

  • Data analysis and reporting

  • Quality control measures during testing

    • Test Conditions and Methodology

    The USP <71> Sterility Test for Parenteral Drug Products is conducted using the following steps:

    1. Sample preparation: Samples are prepared according to standard procedures, including sterilization, extraction, and filtration.

    2. Testing equipment and instruments: Equipment such as the SAS (Sterilization Assay System) or other similar systems are used to conduct the test.

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

    4. Measurement and analysis methods: The test results are analyzed using statistical methods to determine sterility.

    Calibration and validation procedures include:

  • Equipment calibration

  • Validation of testing procedures

  • Verification of results

    • Quality control measures during testing include:

  • Monitoring equipment performance

  • Maintaining accurate records

  • Ensuring proper sampling procedures

    • Data collection and recording procedures include:

  • Accurate documentation of test results

  • Maintenance of quality control records

  • Compliance with regulatory requirements

    • Test Reporting and Documentation

    The USP <71> Sterility Test for Parenteral Drug Products report includes:

  • Summary of test methods and equipment used

  • Results of testing, including statistical analysis

  • Conclusion and recommendations

  • Quality control measures taken during testing

    • Reporting standards and formats include:

  • Standardized reporting templates

  • Electronic reporting systems

  • Compliance with regulatory requirements

    • Certification and accreditation aspects include:

  • Laboratory accreditation by recognized accrediting bodies

  • Certification of personnel involved in testing

  • Compliance with regulatory requirements

    • Why This Test Should Be Performed

    The benefits and advantages of performing the USP <71> Sterility Test for Parenteral Drug Products include:

  • Prevention of contamination and product recalls

  • Ensuring compliance with regulatory requirements

  • Maintaining product quality and consistency

  • Avoiding costly recalls and reputational damage

    • Risk assessment and mitigation through testing include:

  • Identifying potential risks to patients and personnel

  • Implementing measures to prevent contamination

  • Regularly monitoring equipment performance and testing procedures

    • Quality assurance and compliance benefits include:

  • Ensuring compliance with regulatory requirements

  • Maintaining accurate records of testing and quality control

  • Compliance with industry standards and best practices

    • Why EUROLAB Should Provide This Service

    EUROLABs expertise and capabilities in providing the USP <71> Sterility Test for Parenteral Drug Products include:

  • Experienced personnel trained in sterilization testing

  • State-of-the-art equipment calibrated and validated regularly

  • Compliance with regulatory requirements and industry standards

    • Conclusion

    The USP <71> Sterility Test for Parenteral Drug Products is a crucial laboratory testing service that ensures the sterility of parenteral drug products. EUROLABs expertise and capabilities in providing this service make us an ideal choice for companies requiring high-quality sterilization testing.

    By performing this test, companies can ensure compliance with regulatory requirements, maintain product quality and consistency, and avoid costly recalls and reputational damage. EUROLAB is committed to providing accurate and reliable results, ensuring that our clients products meet the highest standards of sterility.

    If you are looking for a trusted laboratory partner to provide high-quality sterilization testing services, please do not hesitate to contact us today. We look forward to serving your needs and helping you maintain product quality and compliance with regulatory requirements.

    References

  • USP <71> Sterilization and Sterility Testing

  • ISO 11137 Sterilization of Health Care Products - Radiation

  • ASTM F2103 Standard Test Method for Sterility Testing

  • EN 556-1 Sterilization indicators in medical applications

  • TSE TS EN 556-1

    • This document is intended to provide general information and guidance on the USP <71> Sterility Test for Parenteral Drug Products. It is not intended to be a comprehensive or definitive source of information, and should not be relied upon as such.

    EUROLAB disclaims any liability for any loss or damage arising from reliance on this document.

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers