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ep-315-polyethylene-used-in-pharmaceutical-containers
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 3.1.6 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 3.1.5 Polyethylene Used in Pharmaceutical Containers Testing Service by Eurolab

EP 3.1.5 Polyethylene Used in Pharmaceutical Containers testing is governed by a multitude of international and national standards, which are essential for ensuring the quality and safety of polyethylene containers used in pharmaceutical applications.

Overview of Relevant Standards

  • ISO 11607-1:2016: Packaging for terminally sterilized medical devices - Part 1: Requirements for packaging systems

  • ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and testing of barriers used in sterile packaging of medical devices

  • USP <381>: Polyethylene Resins for Containers

  • EP 3.1.5: Polyethylene Used in Pharmaceutical Containers

    • These standards outline the specific requirements for polyethylene containers, including their physical and chemical properties, material characterization, and testing procedures.

    Legal and Regulatory Framework Surrounding Testing Service

    The legal and regulatory framework surrounding EP 3.1.5 Polyethylene Used in Pharmaceutical Containers testing is governed by a variety of national and international regulations, including:

  • USP <381>: Provides guidelines for the selection and use of polyethylene resins in pharmaceutical containers

  • 21 CFR Part 211: Current Good Manufacturing Practice (CGMP) in manufacturing, processing, packing, or holding of drugs

  • EU GMP Annex 1: Sterilization

    • Conducting EP 3.1.5 testing ensures compliance with these regulations and standards.

    International and National Standards that Apply to This Specific Laboratory Test

    The following international and national standards apply to the specific laboratory test:

  • ISO/TS 16949:2016: Quality management systems - Automotive specifications

  • EN ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for packaging systems

  • ASTM F2025-19: Standard Test Methods for Testing Plastic Pouches Used in Sterilization and Aseptic Processing

    • These standards ensure the quality and reliability of polyethylene containers used in pharmaceutical applications.

    Standard Development Organizations and Their Role

    The development and maintenance of these standards are carried out by various standard development organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • Deutsches Institut für Normung (DIN)

    • These organizations work together to ensure the quality and reliability of polyethylene containers used in pharmaceutical applications.

    Evolution of Standards and Updates

    Standards evolve and get updated periodically to reflect new developments, technologies, and requirements. The following updates are notable:

  • ISO 11607-1:2016: Updates the requirements for packaging systems

  • ISO 11607-2:2019: Updates the validation requirements for forming, sealing and testing of barriers used in sterile packaging of medical devices

    • Regularly reviewing and updating standards ensures compliance with evolving regulations and technologies.

    Specific Standard Numbers and Their Scope

    The following standard numbers are relevant to EP 3.1.5 Polyethylene Used in Pharmaceutical Containers testing:

  • ISO/TS 16949:2016: Quality management systems - Automotive specifications

  • EN ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for packaging systems

  • ASTM F2025-19: Standard Test Methods for Testing Plastic Pouches Used in Sterilization and Aseptic Processing

    • Each standard outlines specific requirements and testing procedures.

    Compliance Requirements for Different Industries

    Compliance with these standards is required by various industries, including:

  • Pharmaceutical industry

  • Medical device industry

  • Food packaging industry

    • These industries require compliance with relevant standards to ensure the quality and safety of their products.

    The testing service for EP 3.1.5 Polyethylene Used in Pharmaceutical Containers is necessary due to the critical role that polyethylene containers play in pharmaceutical applications.

    Business and Technical Reasons for Conducting Testing

    Polyethylene containers are used extensively in the pharmaceutical industry, and their quality and safety have a direct impact on patient health and safety. Conducting testing ensures compliance with regulations and standards.

    Consequences of Not Performing This Test

    Failure to conduct EP 3.1.5 testing can result in non-compliance with regulations, compromised product safety, and damaged brand reputation.

    Industries and Sectors that Require This Testing

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

  • Pharmaceutical industry

  • Medical device industry

  • Food packaging industry

    • These industries require compliance with relevant standards to ensure the quality and safety of their products.

    Quality Requirements for Polyethylene Containers

    Polyethylene containers must meet specific quality requirements, including:

  • Material characterization

  • Physical properties (e.g., tensile strength)

  • Chemical resistance

    • Conducting testing ensures compliance with these quality requirements.

    Laboratory Test Methodologies and Equipment

    The following laboratory test methodologies and equipment are used for EP 3.1.5 Polyethylene Used in Pharmaceutical Containers testing:

  • Material characterization (e.g., FTIR, GC-MS)

  • Physical properties testing (e.g., tensile strength, impact resistance)

  • Chemical resistance testing

    • These test methodologies and equipment ensure accurate and reliable results.

    Laboratory Accreditation and Certification

    The laboratory conducting EP 3.1.5 Polyethylene Used in Pharmaceutical Containers testing must be accredited and certified by recognized accrediting bodies, including:

  • ISO/IEC 17025

  • ISO 15189

    • Accreditation and certification ensure the quality and reliability of the test results.

    Conclusion

    The testing service for EP 3.1.5 Polyethylene Used in Pharmaceutical Containers is critical for ensuring compliance with regulations and standards, product safety, and brand reputation.

    By following this comprehensive guide, you can ensure that your polyethylene containers meet the required quality and safety standards.

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