EUROLAB
ep-313-polyolefins-in-contact-with-injectable-preparations
Extractables and Leachables 21 CFR 174.5 General Requirements for Indirect Food Additives – E&L21 CFR 175.300 Resinous and Polymeric Coatings – Leachables Control21 CFR 176.170 Substances in Contact with Aqueous Foods – Extractables21 CFR 177.1520 Leachable Migration Limits for Polyolefins21 CFR 177.1630 Polyethylene Terephthalate Polymers – Leachables LimitASTM D6288 Volatile Organic Compounds Determination by GC/MSASTM D6499 N-nitrosamines Extraction from Rubber ComponentsASTM D7823 Screening of Phthalates in Plastic ComponentsASTM D7896 Analysis of Leachables in Water by LC-MS/MSASTM D8147 Non-Volatile Extractables in Polymeric MaterialsASTM E2406 Leachables from Sterile Barrier SystemsASTM F1980 Accelerated Aging for Stability of ExtractablesASTM F2459 Extractable Residue from Metallic Medical ComponentsASTM F3136 Evaluation of Leachables in Drug Delivery DevicesEMA Guideline on Plastic Immediate Packaging Materials – E&LEP 2.9.47 Container Closure System Integrity Testing for ExtractablesEP 3.1.4 Polypropylene for Containers in ParenteralsEP 3.1.5 Polyethylene Used in Pharmaceutical ContainersEP 3.1.6 Polyethylene Terephthalate Containers – Leachable SafetyEP 3.2.2 Plastic Containers and Closures for Pharmaceutical UseEP 3.2.8 Closures for Containers for Aqueous Parenteral PreparationsEP 3.2.9 Rubber Closures – Extractables AnalysisEP 5.1.1 Biological Safety – Leachables Toxicity AssessmentFDA 21 CFR 211.94 Container Closure System Suitability – Extractables RiskFDA Guidance: Container Closure Systems for Drug Products – E&L FocusFDA Guidance: Orally Inhaled and Nasal Drug Products – Leachables ReviewHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsICH Q3D Risk-Based Assessment of Elemental Impurities in LeachablesISO 10993-12 Sample Preparation for Extractables TestingISO 10993-13 Degradation Products Analysis for Polymeric Medical DevicesISO 10993-14 Identification of Degradation Products from CeramicsISO 10993-15 Identification of Degradation Products from MetalsISO 10993-17 Toxicological Risk Assessment for LeachablesISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 11607-1 Package Integrity for Sterile Medical DevicesISO 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 14937 Sterilization and Extractables Safety AssuranceISO 15759 Analysis of Packaging for Contact with Parenteral DrugsISO 17664 Processing of Leachable-Safe Reusable Medical DevicesISO 18562-1 Leachables Testing for Breathing Gas Pathways in HealthcareISO 18562-2 Volatile Organic Compounds Testing from Medical DevicesISO 18562-3 Condensate Leachables Testing from Gas Pathway EquipmentISO 18562-4 Leachable Particulates in Medical Gas Pathway DevicesISO/TR 10993-33 Guidance on E&L Assessment Strategy for DevicesJP 2.20 Extractables from Rubber Stoppers by GC-MSJP 6.02 Aluminum Cap Material Leachables TestingJP 6.07 Plastic Containers for Aqueous Injections – Leachable StandardsJP 6.10 Gas Permeability and Volatile Leachable ReleaseJP 7.02 Residual Solvent and Leachable IdentificationJP 7.04 Container/Closure Leachable Migration EvaluationPDA TR No. 66 Defining Leachables Risk in Biologics ProductionPDA TR No. 85 Extractables and Leachables in Manufacturing SystemsPh. Int. General Method 3.10 Leachable Profiling of Packaging MaterialsUSP <1031.1> Analytical Instrument Qualification for Extractables StudiesUSP <1031> Analytical Method Validation for Extractables StudiesUSP <1058> Analytical Instrument Qualification for Leachables TestingUSP <1079> Good Storage and Distribution Practices – Leachable RiskUSP <1086> Impurities – Extractables Risk ProfilingUSP <1088> Inhalation and Nasal Drug Products – Leachables TestingUSP <1207> Container Closure Integrity and Leachable EntryUSP <1231> Water for Pharmaceutical Purposes – Leachables RiskUSP <1661> Evaluation of Plastic Packaging Systems for Drug ProductsUSP <1663> Extractables Testing for Plastic Components in Drug PackagingUSP <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <671> Stability and Buffering Capacity in Plastic ContainersUSP <800> Hazardous Drug Handling – Leachables from PackagingUSP <87> Biological Reactivity Test: In Vitro CytotoxicityUSP <88> Biological Reactivity Test: In Vivo Irritation & ToxicityUSP <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

Comprehensive Guide to EP 3.1.3 Polyolefins in Contact with Injectable Preparations Laboratory Testing Service

Provided by Eurolab

Standard-Related Information

The testing of polyolefins in contact with injectable preparations is governed by a range of international and national standards. These standards ensure that the materials used for medical devices are safe, reliable, and compliant with regulatory requirements.

  • ISO 10993-1:2018: This standard provides a framework for evaluating the biological compatibility of medical devices. It outlines the tests required to assess the potential risks associated with device-material interactions.

  • ISO 10993-12:2012: This standard specifies the test methods for evaluating the cytotoxicity of materials in contact with injectable preparations.

  • USP <87> and USP <88>: These standards outline the requirements for testing the compatibility of medical devices with injectable preparations.

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding EP 3.1.3 Polyolefins in Contact with Injectable Preparations testing is governed by various national and international regulations.

  • Medical Device Regulation (MDR): This regulation requires manufacturers to demonstrate the safety and performance of their medical devices through conformity assessment procedures.

  • In Vitro Diagnostic Medical Devices Regulation (IVDR): This regulation sets out requirements for the testing and certification of in vitro diagnostic medical devices, including injectable preparations.

    • Standard Development Organizations

    Standard development organizations play a crucial role in establishing and maintaining standards for EP 3.1.3 Polyolefins in Contact with Injectable Preparations testing.

  • International Organization for Standardization (ISO): ISO is responsible for developing and publishing international standards for a wide range of industries, including medical devices.

  • American Society for Testing and Materials (ASTM): ASTM develops and publishes standards for materials, products, and services used in various industries, including medical devices.

    • Standard Requirements and Needs

    The testing of polyolefins in contact with injectable preparations is essential to ensure the safety and performance of medical devices.

  • Business and Technical Reasons: The testing of polyolefins in contact with injectable preparations is required to demonstrate compliance with regulatory requirements and to ensure the safety and performance of medical devices.

  • Consequences of Not Performing this Test: Failure to perform this test can result in product recall, regulatory non-compliance, and damage to a companys reputation.

    • Industries and Sectors that Require this Testing

    This testing is required for various industries and sectors, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Research institutions

    • Risk Factors and Safety Implications

    The risk factors associated with the use of polyolefins in contact with injectable preparations include:

  • Chemical leaching from materials into injectable preparations

  • Incompatibility between materials and injectable preparations

  • Allergic reactions or sensitization to materials

    • Test Conditions and Methodology

    The testing of polyolefins in contact with injectable preparations involves the following steps:

    1. Sample Preparation: The sample is prepared according to standard procedures.

    2. Testing Parameters: The testing parameters are set according to standard requirements.

    3. Measurement and Analysis: The test results are measured and analyzed using calibrated equipment.

    Test Reporting and Documentation

    The test report includes:

  • A summary of the test procedure

  • Test results and data

  • Interpretation of test results

  • Conclusion and recommendations

    • Why this Test Should be Performed

    This testing is essential for:

  • Ensuring product safety and performance

  • Demonstrating regulatory compliance

  • Building customer confidence and trust

  • Enhancing competitiveness and market positioning

    • Why Eurolab Should Provide this Service

    Eurolabs expertise, experience, and state-of-the-art equipment make it an ideal provider of EP 3.1.3 Polyolefins in Contact with Injectable Preparations laboratory testing services.

  • Expertise and Experience: Eurolab has extensive experience in testing polyolefins in contact with injectable preparations.

  • State-of-the-Art Equipment: Eurolabs equipment is calibrated and validated to ensure accurate results.

  • Accreditation and Certification: Eurolab is accredited by national and international accreditation bodies.

    • Additional Requirements

    The following requirements are essential for the testing of polyolefins in contact with injectable preparations:

  • Sample preparation according to standard procedures

  • Testing parameters set according to standard requirements

  • Measurement and analysis using calibrated equipment

    • Conclusion

    The testing of polyolefins in contact with injectable preparations is a critical aspect of ensuring product safety, performance, and regulatory compliance. Eurolabs expertise, experience, and state-of-the-art equipment make it an ideal provider of this laboratory testing service.

    Eurolabs Expertise in EP 3.1.3 Polyolefins in Contact with Injectable Preparations Testing

  • Accreditation: Eurolab is accredited by national and international accreditation bodies.

  • Experience: Eurolab has extensive experience in testing polyolefins in contact with injectable preparations.

  • Equipment: Eurolabs equipment is calibrated and validated to ensure accurate results.

    • Contact Us

    For more information about EP 3.1.3 Polyolefins in Contact with Injectable Preparations laboratory testing services, please contact:

    Eurolab

    Insert Contact Information

    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