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usp-381-elastomeric-closures-for-injections-extractable-profile
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 3.1.3 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 <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

USP <381> Elastomeric Closures for Injections: Extractable Profile Laboratory Testing Service Provided by Eurolab

Standard-Related Information

The United States Pharmacopeia (USP) <381> Elastomeric Closures for Injections: Extractable Profile is a critical testing service that ensures the safety and efficacy of elastomeric closures used in injectable products. This article provides a comprehensive overview of the relevant standards, legal and regulatory framework, and international and national standards governing this testing service.

Relevant Standards

  • ISO 8536-2 (Elastomeric closure for cartridges and ampoules)

  • ASTM F2393 (Standard Specification for Elastomeric Closures for Cartridges and Ampoules)

  • EN 14338 (Elastomeric closures for vials, syringes, ampoules and cartridges)

  • TSE 16351 (Elastomeric closures for injectable products)

    • These standards specify the requirements for elastomeric closures, including extractable profile testing. Eurolab is committed to complying with these standards and ensuring that its customers products meet the required specifications.

    Standard Development Organizations

    The standard development organizations responsible for creating and updating these standards include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations work collaboratively to develop and maintain standards that ensure product safety, quality, and performance.

    Standard Evolution and Update

    Standards are constantly evolving to reflect advances in technology and changing regulatory requirements. Eurolab stays up-to-date with the latest revisions and updates to ensure that its testing services remain compliant with current regulations.

    International and National Standards

    The following standards apply to elastomeric closures for injectable products:

  • ISO 8536-2:2018(Elastomeric closure for cartridges and ampoules)

  • ASTM F2393-18 (Standard Specification for Elastomeric Closures for Cartridges and Ampoules)

  • EN 14338:2017(Elastomeric closures for vials, syringes, ampoules and cartridges)

  • TSE 16351:2018(Elastomeric closures for injectable products)

    • These standards specify the requirements for extractable profile testing, including the types of extractables to be tested, the test methods, and the acceptance criteria.

    Industry-Specific Requirements

    Different industries have varying compliance requirements for elastomeric closures. For example:

  • Pharmaceuticals: USP <381> Elastomeric Closures for Injections: Extractable Profile

  • Biotechnology: ISO 8536-2 (Elastomeric closure for cartridges and ampoules)

  • Medical Devices: EN 14338 (Elastomeric closures for vials, syringes, ampoules and cartridges)

    • Eurolab understands the specific requirements of each industry and ensures that its testing services meet the relevant standards.

    Standard Compliance Requirements

    To ensure compliance with standards, manufacturers must:

  • Conduct extractable profile testing according to USP <381> or equivalent international standard

  • Provide documentation of test results and certification

  • Verify that elastomeric closures meet the specified requirements

    • Eurolab provides comprehensive testing services to help manufacturers comply with these regulations.

    Standard-Related Risks

    Failure to comply with standards can result in:

  • Product recalls

  • Regulatory non-compliance fines

  • Loss of business reputation

  • Reduced customer confidence and trust

    • Eurolabs expertise and experience ensure that its customers products meet the required specifications, reducing the risk of regulatory issues.

    Standard Compliance Benefits

    Complying with standards offers numerous benefits, including:

  • Enhanced product safety and efficacy

  • Improved customer satisfaction and loyalty

  • Increased business reputation and credibility

  • Reduced costs associated with non-compliance

    • Eurolab helps its customers achieve these benefits by providing comprehensive testing services that meet the relevant standards.

    Standard-Related Documents

    The following documents are required for compliance with USP <381> Elastomeric Closures for Injections: Extractable Profile:

  • Certificate of Analysis (COA)

  • Test Report

  • Batch Record

  • Quality Control Document

    • Eurolab provides these documents to its customers, ensuring that they meet the required specifications.

    Why This Standard-Related Testing Service is Required

    This testing service is essential for ensuring product safety and efficacy. Elastomeric closures can leach chemicals into injectable products, compromising their quality and performance. Extractable profile testing identifies these potential contaminants, enabling manufacturers to take corrective action.

    Test Conditions and Methodology

    Eurolabs expert technicians conduct extractable profile testing according to the USP <381> protocol. The test involves:

  • Sample preparation

  • Test method selection (e.g., HPLC, GC)

  • Data analysis

    • The results are reported in a comprehensive Test Report, which includes:

  • Extractables data

  • Acceptance criteria met/not met

  • Recommendations for corrective action (if necessary)

    • Standard-Related Testing Services

    Eurolab offers the following testing services related to elastomeric closures:

  • Extractable Profile Testing

  • Leachables Testing

  • Package Integrity Testing

    • These services help manufacturers ensure product safety and efficacy, reducing the risk of regulatory issues.

    Conclusion

    USP <381> Elastomeric Closures for Injections: Extractable Profile is a critical testing service that ensures product safety and efficacy. Eurolabs comprehensive testing services meet the required standards, providing customers with peace of mind and compliance assurance.

    Please contact us to learn more about our standard-related testing services.

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    Standard-Related Frequently Asked Questions

    Q: What is USP <381> Elastomeric Closures for Injections: Extractable Profile?

    A: Its a testing service that ensures elastomeric closures used in injectable products meet the required specifications.

    Q: Which international and national standards apply to elastomeric closures for injectable products?

    A: ISO 8536-2, ASTM F2393, EN 14338, TSE 16351.

    Q: What types of extractables are tested during this service?

    A: Chemicals leached from the elastomeric closure into the product.

    Q: Why is it essential to comply with these standards?

    A: To ensure product safety and efficacy, reduce regulatory non-compliance fines, and maintain business reputation.

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    Eurolabs Standard-Related Expertise

    Our expert technicians have extensive experience in conducting extractable profile testing according to USP <381> protocols. We provide comprehensive testing services that meet the required standards, ensuring our customers products are safe and effective. Contact us today to learn more about our standard-related testing services.

    Eurolabs Testing Services

  • Extractable Profile Testing

  • Leachables Testing

  • Package Integrity Testing

    • Our expert technicians use state-of-the-art equipment to ensure accurate results. We provide comprehensive Test Reports, including extractables data and acceptance criteria met/not met.

    Conclusion

    USP <381> Elastomeric Closures for Injections: Extractable Profile is a critical testing service that ensures product safety and efficacy. Eurolabs comprehensive testing services meet the required standards, providing customers with peace of mind and compliance assurance.

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

    CONTACT US +902127020000

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