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usp-1222-terminally-sterilized-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 <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 ProductsUSP <71> Sterility Test for Parenteral Drug Products

USP <1222> Terminally Sterilized Drug Products Laboratory Testing Service: A Comprehensive Guide

The USP <1222> standard for terminally sterilized drug products is a critical requirement for ensuring the safety and efficacy of pharmaceuticals. This standard outlines the requirements for laboratory testing to ensure that these products meet specific criteria.

International Standards

  • ISO 11137-1:2019(E) Sterilization of medical devices Part 1: Requirements for validation and routine control of sterilization processes

  • ASTM E2500-17: Standard Practice for Addressing the Risk of IgM Antibody-Mediated Hemolysis (AIH)

  • EN ISO 11137-2:2019 Sterilization of medical devices Part 2: Guidance on the application of ISO 11137-1

  • TSE KDV 2015/83/EU Medical Devices Regulation

    • Regulatory Framework

    The regulatory framework surrounding USP <1222> testing is governed by various national and international regulations, including:

  • United States Pharmacopeia (USP)

  • European Medicines Agency (EMA)

  • Food and Drug Administration (FDA)

  • International Organization for Standardization (ISO)

    • Standard Development Organizations

    The development of standards for USP <1222> testing is the responsibility of various organizations, including:

  • ISO Technical Committee 198

  • ASTM Subcommittee F02.45

  • EN Committee CEN/TC 204

    • Evolution and Updates

    Standards evolve over time to reflect new technologies and scientific advancements. The update cycle for USP <1222> typically occurs every 5-10 years.

    The need for USP <1222> testing arises from the importance of ensuring product safety and efficacy. This testing is critical in various industries, including:

  • Pharmaceuticals

  • Medical devices

  • Cosmetics

    • Business and Technical Reasons

    Conducting USP <1222> testing ensures compliance with regulatory requirements, reduces liability risks, and provides assurance that products meet specific criteria.

    Consequences of Non-Compliance

    Failure to perform USP <1222> testing can result in product recalls, fines, and damage to reputation.

    The test conditions for USP <1222> testing involve the following steps:

    1. Sample Preparation: Preparing samples according to specific protocols.

    2. Testing Equipment and Instruments: Using calibrated equipment and instruments to perform tests.

    3. Testing Environment Requirements: Maintaining a controlled environment with precise temperature, humidity, and pressure conditions.

    4. Measurement and Analysis Methods: Conducting measurements using standardized methods.

    Calibration and Validation

    Calibration and validation procedures ensure the accuracy of testing equipment and instruments.

    The reporting and documentation requirements for USP <1222> testing involve:

  • Report Format and Structure: Presenting results in a clear, concise manner.

  • Interpretation of Test Results: Analyzing data to determine product compliance.

  • Certification and Accreditation: Ensuring the credibility of test reports.

    • Certification and Accreditation

    Certification and accreditation provide assurance that testing services meet specific standards.

    Performing USP <1222> testing provides numerous benefits, including:

  • Risk Assessment and Mitigation: Reducing liability risks through compliance.

  • Quality Assurance and Compliance: Ensuring products meet regulatory requirements.

  • Competitive Advantages and Market Positioning: Demonstrating commitment to quality.

    • Why Eurolab Should Provide This Service

    Eurolab, a leading provider of laboratory testing services, offers expert knowledge, state-of-the-art equipment, and certified personnel.

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

    CONTACT US +902127020000

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