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usp-1664-leachables-analysis-for-container-closure-systems
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 <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

USP <1664> Leachables Analysis for Container Closure Systems Laboratory Testing Service: A Comprehensive Guide

As a leading laboratory testing service provider, Eurolab offers expert solutions for USP <1664> Leachables Analysis for Container Closure Systems testing. This article serves as a complete reference guide, covering all aspects of the testing service, from standard-related information to test reporting and documentation.

USP <1664> Leachables Analysis for Container Closure Systems testing is governed by various international and national standards. The primary governing bodies include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • The legal and regulatory framework surrounding this testing service includes:

  • USP <1664> Leachables Analysis for Container Closure Systems

  • ISO 10993-18:2018 Biological evaluation of medical devices - Part 18: Chemical characterization of materials

  • ASTM F2393-11 Standard Guide for Evaluation of Alternative Extraction Solutions

    • Standard development organizations, such as ISO and ASTM, play a crucial role in creating and updating standards. These organizations collaborate with industry stakeholders to ensure that standards reflect the latest scientific knowledge and technological advancements.

    Standards evolve through:

    1. Review: Periodic review of existing standards to identify areas for improvement or update.

    2. Revision: Updating existing standards to reflect new information or changes in regulations.

    3. Replacement: Replacing outdated standards with new ones that better reflect current practices.

    Relevant standard numbers and their scope include:

  • ISO 10993-18:2018: Biological evaluation of medical devices - Part 18: Chemical characterization of materials

  • ASTM F2393-11: Standard Guide for Evaluation of Alternative Extraction Solutions

    • Standard compliance requirements vary across industries, but generally involve:

    1. Adherence to specific testing protocols and procedures.

    2. Use of approved testing equipment and instruments.

    3. Compliance with regulatory agency requirements.

    This specific test is needed and required for several reasons:

    1. Business and Technical Reasons: Conducting USP <1664> Leachables Analysis for Container Closure Systems testing ensures the safety and efficacy of medical devices, ensuring compliance with regulatory requirements.

    2. Consequences of Not Performing this Test: Failure to conduct this test can lead to product recalls, reputational damage, and financial losses.

    3. Industries and Sectors: This testing is required in various industries, including:

    Pharmaceutical

    Medical device manufacturing

    Biotechnology

    4. Risk Factors and Safety Implications: Leachables can pose significant risks to patients, including toxicity, allergic reactions, and other adverse effects.

    5. Quality Assurance and Quality Control Aspects: This test contributes to product safety and reliability by ensuring that container closure systems meet regulatory requirements.

    This testing provides several benefits:

    1. Competitive Advantages: Demonstrating compliance with USP <1664> standards can enhance a companys reputation and competitiveness in the market.

    2. Cost-Benefit Analysis: Performing this test can lead to long-term cost savings by preventing product recalls, litigation, and reputational damage.

    The testing process involves:

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

    2. Testing Parameters and Conditions: Conducting tests under controlled conditions, including temperature, humidity, and pressure.

    3. Measurement and Analysis Methods: Using various analytical techniques, such as chromatography and spectroscopy.

    4. Calibration and Validation Procedures: Ensuring that testing equipment is calibrated and validated according to specific protocols.

    5. Quality Control Measures during Testing: Implementing quality control measures to ensure accurate and reliable test results.

    Eurolab provides detailed reporting and documentation for USP <1664> Leachables Analysis for Container Closure Systems testing, including:

    1. Report Format and Structure: Reports are structured according to specific protocols and standards.

    2. Interpretation of Test Results: Expert interpretation of test results is provided.

    3. Certification and Accreditation Aspects: Eurolabs certification and accreditation status is documented.

    4. Traceability and Documentation Requirements: All testing data is recorded and stored in accordance with regulatory requirements.

    Performing USP <1664> Leachables Analysis for Container Closure Systems testing offers numerous benefits:

    1. Risk Assessment and Mitigation through Testing

    2. Quality Assurance and Compliance Benefits: Demonstrating compliance with regulatory requirements.

    3. Competitive Advantages and Market Positioning: Enhancing a companys reputation and competitiveness in the market.

    4. Cost Savings and Efficiency: Long-term cost savings by preventing product recalls, litigation, and reputational damage.

    Why Choose Eurolab (Commercial Appeal)

    Eurolab offers expert solutions for USP <1664> Leachables Analysis for Container Closure Systems testing, including:

    1. Experienced Staff: Highly skilled technicians with extensive experience in laboratory testing.

    2. State-of-the-Art Equipment and Facilities: Utilizing the latest technology and equipment to ensure accurate and reliable test results.

    3. Comprehensive Reporting and Documentation: Detailed reporting and documentation to meet regulatory requirements.

    In conclusion, USP <1664> Leachables Analysis for Container Closure Systems testing is a critical aspect of ensuring product safety and efficacy in various industries. By choosing Eurolabs expert solutions, companies can ensure compliance with regulatory requirements, mitigate risks, and maintain competitiveness in the market.

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

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