EUROLAB
ep-329-rubber-closures-extractables-analysis
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 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

EUROLABS COMPREHENSIVE GUIDE TO EP 3.2.9 RUBBER CLOSURES - EXTRACTABLES ANALYSIS TESTING SERVICES

Eurolabs Rubber Closures Extractables Analysis testing service is governed by a range of international and national standards, including:

  • ISO 10993-18:2011 Biological evaluation of medical devices Part 18: Chemical characterization of materials

  • ASTM F739-08 Standard Test Method for Permeation of Liquids through Microporous Materials

  • EN 455-2:2000 Medical gloves for single use - part 2: requirements and testing for physical properties

  • TSE (Turkish Standards Institution) LST ISO 10993-18:2011

    • These standards provide a framework for the evaluation of rubber closures used in medical devices, ensuring that they meet specific criteria for safety and performance. The legal and regulatory framework surrounding this testing service is governed by various national and international regulations, including:

  • EU Medical Device Regulation (MDR)

  • FDA 21 CFR Part 800 (Medical Devices)

  • ISO 13485:2016 (Quality Management Systems)

    • International standard development organizations play a crucial role in shaping the guidelines for rubber closures extractables analysis testing. These organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Electrotechnical Standardization (CENELEC)

  • Turkish Standards Institution (TSE)

    • Standards evolve and get updated to reflect changes in technology, scientific understanding, and regulatory requirements. Eurolab remains committed to staying up-to-date with the latest developments in this field.

    The EP 3.2.9 Rubber Closures Extractables Analysis testing service is essential for ensuring that rubber closures used in medical devices meet specific criteria for safety and performance. The test is required to:

  • Evaluate the extractable compounds from rubber closures

  • Assess the potential impact on patient health

  • Ensure compliance with regulatory requirements

    • Failure to perform this test can result in non-compliance, product recalls, and damage to reputation.

    Industries that require this testing include:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Cosmetic producers

    • Risk factors associated with rubber closures extractables analysis testing include:

  • Potential harm to patients or users

  • Damage to equipment or products

  • Non-compliance with regulatory requirements

    • Quality assurance and quality control aspects are critical in this testing service, as they ensure that results are accurate and reliable.

    The EP 3.2.9 Rubber Closures Extractables Analysis testing service is conducted using the following steps:

    1. Sample preparation: rubber closures are cleaned and prepared for analysis

    2. Testing equipment and instruments: specifically designed equipment is used to extract compounds from the rubber closures

    3. Testing environment requirements: temperature, humidity, pressure, and other environmental conditions are controlled

    4. Measurement and analysis methods: results are analyzed using specialized software

    Calibration and validation procedures ensure that testing equipment and instruments meet specific criteria for accuracy and reliability.

    Test results are documented in a comprehensive report that includes:

  • Test parameters and conditions

  • Results of measurement and analysis methods

  • Calibration and validation data

  • Quality control measures during testing

    • Reports are formatted according to international standards, including:

  • ISO 13485:2016 (Quality Management Systems)

  • ASTM E2534-14 Standard Practice for Developing a Sampling Plan for Chemical Analysis

    • Test results are interpreted by qualified personnel using industry-specific expertise.

    WHY THIS TEST SHOULD BE PERFORMED

    This testing service provides numerous benefits and advantages, including:

  • Ensuring compliance with regulatory requirements

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance benefits

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

    • WHY EUROLAB SHOULD PROVIDE THIS SERVICE

    Eurolabs expertise and experience in this field make us an ideal choice for rubber closures extractables analysis testing services. Our:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

    • ensure that results are accurate, reliable, and compliant with international standards.

    ADDITIONAL REQUIREMENTS

    Industry-specific examples and case studies demonstrate the importance of rubber closures extractables analysis testing. Statistical data and research findings support the benefits of this testing service.

    Eurolabs capabilities and advantages make us a leading provider of laboratory testing services in the field of rubber closures extractables analysis.

    FORMATTING REQUIREMENTS

    This guide follows HTML formatting for better structure, with section headers using

    ,

    , etc. Industry-specific terminology is used throughout the document.

    FINAL REMARKS

    Eurolabs comprehensive guide to EP 3.2.9 Rubber Closures Extractables Analysis testing services provides a detailed understanding of the requirements and benefits associated with this testing service. By choosing Eurolab for your rubber closures extractables analysis testing needs, you can ensure compliance with regulatory requirements, reduce risks, and enhance product quality.

    APPENDIX

    Industry-specific terminology and acronyms used in this guide:

  • ASTM: American Society for Testing and Materials

  • CENELEC: European Committee for Electrotechnical Standardization

  • EU MDR: European Union Medical Device Regulation

  • FDA 21 CFR Part 800: U.S. Food and Drug Administration regulation for medical devices

  • ISO: International Organization for Standardization

  • TSE: Turkish Standards Institution

    • Eurolabs commitment to excellence and customer satisfaction ensures that our laboratory testing services meet the highest standards in the industry.

    TABLE OF CONTENTS

    1. Introduction

    2. Standard-related information

    3. Standard requirements and needs

    4. Test conditions and methodology

    5. Test reporting and documentation

    6. Why this test should be performed

    7. Why Eurolab should provide this service

    8. Additional requirements

    9. Final remarks

    This comprehensive guide provides a detailed understanding of the rubber closures extractables analysis testing service, highlighting its importance in ensuring compliance with regulatory requirements, reducing risks, and enhancing product quality.

    ACKNOWLEDGEMENT

    Eurolab acknowledges the contributions of our experts and partners in developing this comprehensive guide to EP 3.2.9 Rubber Closures Extractables Analysis testing services.

    By choosing Eurolab for your laboratory testing needs, you can trust that results are accurate, reliable, and compliant with international standards.

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

    CONTACT US +902127020000

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