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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 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 3.1.3 Polyolefins in Contact with Injectable PreparationsEP 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

ASTM E2406 Leachables from Sterile Barrier Systems: A Comprehensive Guide to Laboratory Testing Services Provided by Eurolab

The testing of leachables from sterile barrier systems is governed by various international and national standards, including ASTM E2406. This standard provides a detailed methodology for evaluating the leachable substances that can migrate from sterilization wrap materials into medical devices or other products.

Standard Development Organizations and Their Role

Standard development organizations (SDOs) play a crucial role in creating and maintaining standards related to testing services. In this case, the American Society for Testing and Materials (ASTM) is responsible for developing and publishing ASTM E2406.

International Standards

  • ISO 10993-18:2018 - Biological evaluation of medical devices -- Part 18: Tests for leachable substances

  • EN ISO 10993-18:2018 - Biological evaluation of medical devices -- Part 18: Tests for leachable substances

    • National Standards

  • TSE (Turkish Standard) 1003 - Medical devices -- Particular requirements for the safety and essential performance of sterilization wrap materials

  • NF EN ISO 10993-18 - Biological evaluation of medical devices -- Part 18: Tests for leachable substances

    • Standard Compliance Requirements

    Various industries, including medical device manufacturers, pharmaceutical companies, and biotechnology firms, must comply with these standards to ensure the safety and efficacy of their products.

    Consequences of Non-Compliance

    Failure to comply with ASTM E2406 can result in severe consequences, including product recalls, legal actions, and damage to a companys reputation.

    The testing process involves several steps:

    1. Sample Preparation: Sterilization wrap materials are exposed to various chemicals, such as solvents or surfactants, to simulate the leaching process.

    2. Testing Parameters: The test parameters include temperature, time, and solvent concentration, which are carefully controlled to ensure accurate results.

    3. Measurement and Analysis: The extracted substances are analyzed using techniques like gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-tandem mass spectrometry (LC-MS/MS).

    4. Data Collection and Recording: The test data is collected, recorded, and stored for future reference.

    The test report includes:

  • A summary of the testing procedure

  • Results of the leachable substances analysis

  • Conclusion regarding the compliance of the sterilization wrap material with relevant standards

    • Why This Test Should Be Performed

    Conducting ASTM E2406 testing provides numerous benefits, including:

    1. Quality Assurance: Ensuring product safety and efficacy through rigorous testing.

    2. Compliance: Meeting regulatory requirements for medical devices and pharmaceuticals.

    3. Customer Confidence: Demonstrating a commitment to quality and safety.

    4. Innovation: Driving research and development in the field of sterilization wrap materials.

    Why Eurolab Should Provide This Service

    Eurolabs expertise, state-of-the-art equipment, and certified personnel make them an ideal choice for ASTM E2406 testing services.

    Additional Requirements

  • Industry-specific examples and case studies

  • Statistical data and research findings where applicable

  • Customer testimonials and success stories (fictional but realistic)

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    Contact us for prompt assistance and solutions.

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