EUROLAB
usp-55-biological-indicators-resistance-performance-tests
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 <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

USP <55> Biological Indicators Resistance Performance Tests: Laboratory Testing Services

As a leading provider of laboratory testing services, Eurolab is committed to helping industries and organizations ensure the quality and safety of their products by conducting USP <55> Biological Indicators Resistance Performance Tests. In this comprehensive guide, we will delve into the world of standard-related information, standard requirements and needs, test conditions and methodology, test reporting and documentation, and why this testing service is essential for businesses.

Standard-Related Information

The USP <55> Biological Indicators Resistance Performance Tests standard is a critical guideline that outlines the procedures for evaluating the effectiveness of sterilization processes. This standard is developed by the United States Pharmacopeia (USP), a non-profit organization that sets standards for pharmaceutical products and their manufacturing processes.

Other relevant standards that govern USP <55> Biological Indicators Resistance Performance Tests testing include:

  • ISO 11138: Sterilization of pharmaceutical goods - Biological indicators

  • ASTM E2454-08: Standard Test Method for Evaluating the Resistance to Steam Sterilization of Microbiological Indicators

  • EN 13485: Sterilization of medical devices - Requirements for validation and routine control

    • These standards are essential for ensuring that sterilization processes are effective in eliminating microbiological contaminants from pharmaceutical products.

    Standard Requirements and Needs

    The USP <55> Biological Indicators Resistance Performance Tests standard is required to ensure the safety and efficacy of pharmaceutical products. This testing service helps industries and organizations demonstrate compliance with regulatory requirements, such as those set by the FDA and EU GMP guidelines.

    There are several reasons why this specific test is needed:

  • Ensuring product sterility: USP <55> Biological Indicators Resistance Performance Tests help ensure that sterilization processes are effective in eliminating microbiological contaminants from pharmaceutical products.

  • Compliance with regulatory requirements: This testing service helps industries and organizations demonstrate compliance with regulatory requirements, such as those set by the FDA and EU GMP guidelines.

  • Product safety and reliability: USP <55> Biological Indicators Resistance Performance Tests help ensure that products are safe for use and meet quality standards.

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

  • Product recalls

  • Regulatory fines and penalties

  • Damage to reputation and brand image

    • Test Conditions and Methodology

    The USP <55> Biological Indicators Resistance Performance Tests standard outlines the procedures for evaluating the effectiveness of sterilization processes. This testing service involves the following steps:

    1. Sample preparation: Biological indicators are prepared according to standard protocols.

    2. Sterilization process: The biological indicators are subjected to a sterilization process, such as steam or ethylene oxide sterilization.

    3. Testing and evaluation: The biological indicators are tested for microbial growth after exposure to the sterilization process.

    The testing equipment and instruments used in this service include:

  • Autoclave: A steam sterilizer that uses high-pressure steam to kill microorganisms.

  • Ethylene oxide sterilizer: An instrument that uses ethylene oxide gas to kill microorganisms.

  • Biological indicators: Microbiological organisms that are specifically designed for use as biological indicators in sterilization processes.

    • Test Reporting and Documentation

    The test results are documented and reported according to standard formats, including:

  • Report format: A standard report format is used to document the testing results, including information about the sample, the sterilization process, and the testing conditions.

  • Interpretation of test results: The test results are interpreted based on standard protocols, which include guidelines for evaluating the effectiveness of sterilization processes.

    • Eurolabs laboratory reporting system provides a comprehensive report that includes:

  • Test results: A summary of the testing results, including information about the sample, the sterilization process, and the testing conditions.

  • Conclusion: An evaluation of the effectiveness of the sterilization process based on the test results.

  • Recommendations: Recommendations for future testing or adjustments to the sterilization process.

    • Why This Test Should Be Performed

    The benefits of performing USP <55> Biological Indicators Resistance Performance Tests include:

  • Ensuring product safety and reliability

  • Compliance with regulatory requirements

  • Reducing costs associated with product recalls and regulatory fines

  • Improving customer confidence and trust

  • Enhancing market position and competitiveness

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

  • Product recalls

  • Regulatory fines and penalties

  • Damage to reputation and brand image

    • Why Eurolab Should Provide This Service

    Eurolab is committed to providing high-quality laboratory testing services that meet the needs of industries and organizations. Our expertise in USP <55> Biological Indicators Resistance Performance Tests includes:

  • State-of-the-art equipment: Eurolabs laboratory is equipped with state-of-the-art equipment, including autoclaves and ethylene oxide sterilizers.

  • Experienced personnel: Eurolabs team of experts has extensive experience in conducting USP <55> Biological Indicators Resistance Performance Tests.

  • Comprehensive reporting system: Eurolabs laboratory reporting system provides a comprehensive report that includes all the information necessary for evaluating the effectiveness of sterilization processes.

    • In conclusion, USP <55> Biological Indicators Resistance Performance Tests are an essential part of ensuring product safety and reliability. Eurolab is committed to providing high-quality laboratory testing services that meet the needs of industries and organizations.

    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