EUROLAB
health-canada-gui-0069-plastic-components-in-contact-with-drug-products
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 ReviewICH 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

Health Canada GUI-0069 Plastic Components in Contact with Drug Products Laboratory Testing Service: A Comprehensive Guide

The Health Canada GUI-0069 Plastic Components in Contact with Drug Products testing service is governed by a set of international and national standards that ensure the safety and efficacy of plastic components used in contact with drug products. The following standards are relevant to this testing service:

  • ISO 10993: Biological Evaluation of Medical Devices

  • ASTM F739: Standard Test Method for Permeation of Liquids Through Polymers (Plastic Films)

  • EN ISO 11607-1: Packaging for Terminally Sterilized Single-Use Medical Devices Part 1: Requirements for Materials, Sterilization and Validation

  • TSE L16: Packaging and Packing Materials Specifications for Plastic Components Used in Contact with Drug Products

    • These standards are developed by standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), and Turkish Standards Institution (TS).

    Standard Development Organizations

    Standard development organizations play a crucial role in developing and updating standards. These organizations work closely with industry stakeholders, regulatory bodies, and other experts to ensure that standards are relevant, effective, and up-to-date.

  • ISO: The ISO is an independent, non-governmental organization that develops voluntary international standards for various industries.

  • ASTM: The ASTM is a non-profit organization that develops consensus-based standards for materials, products, and services.

  • CEN: The CEN is the European Committee for Standardization, which develops voluntary standards for various industries.

  • TS: The TS is the Turkish Standards Institution, which develops national standards for various industries.

    • Standard Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. Standard development organizations continuously review and update standards to ensure they remain relevant and effective.

  • Revision cycles: Standards typically undergo revision cycles every 5-10 years.

  • New standard developments: New standards are developed to address emerging issues or technologies.

  • Interpretations and clarifications: Standards may be clarified or interpreted to provide additional guidance on their application.

    • Standard Numbers and Scope

    The following standard numbers and scope are relevant to the Health Canada GUI-0069 Plastic Components in Contact with Drug Products testing service:

  • ISO 10993-1:2018: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • Scope: Specifies general principles for the biological safety assessment of medical devices.

  • ASTM F739-19: Standard Test Method for Permeation of Liquids Through Polymers (Plastic Films)

    • Scope: Describes a test method for determining the permeability of plastic films to liquids.

  • EN ISO 11607-1:2019: Packaging for terminally sterilized single-use medical devices Part 1: Requirements for materials, sterilization and validation

    • Scope: Specifies requirements for packaging materials used in contact with drug products.

    Standard Compliance Requirements

    Compliance with relevant standards is essential to ensure the safety and efficacy of plastic components used in contact with drug products. Industry stakeholders must comply with standard requirements to ensure product safety and regulatory compliance.

  • Material selection: Plastic components must be made from materials that meet standard requirements.

  • Manufacturing processes: Manufacturing processes must be validated to ensure consistency and quality.

  • Testing and evaluation: Products must undergo testing and evaluation to ensure compliance with standard requirements.

    • The Health Canada GUI-0069 Plastic Components in Contact with Drug Products testing service is governed by a set of international and national standards that ensure the safety and efficacy of plastic components used in contact with drug products. The following standards are relevant to this testing service:

  • ISO 10993: Biological Evaluation of Medical Devices

  • ASTM F739: Standard Test Method for Permeation of Liquids Through Polymers (Plastic Films)

  • EN ISO 11607-1: Packaging for Terminally Sterilized Single-Use Medical Devices Part 1: Requirements for Materials, Sterilization and Validation

  • TSE L16: Packaging and Packing Materials Specifications for Plastic Components Used in Contact with Drug Products

    • These standards are developed by standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), and Turkish Standards Institution (TS).

    Standard Development Organizations

    Standard development organizations play a crucial role in developing and updating standards. These organizations work closely with industry stakeholders, regulatory bodies, and other experts to ensure that standards are relevant, effective, and up-to-date.

  • ISO: The ISO is an independent, non-governmental organization that develops voluntary international standards for various industries.

  • ASTM: The ASTM is a non-profit organization that develops consensus-based standards for materials, products, and services.

  • CEN: The CEN is the European Committee for Standardization, which develops voluntary standards for various industries.

  • TS: The TS is the Turkish Standards Institution, which develops national standards for various industries.

    • Standard Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. Standard development organizations continuously review and update standards to ensure they remain relevant and effective.

  • Revision cycles: Standards typically undergo revision cycles every 5-10 years.

  • New standard developments: New standards are developed to address emerging issues or technologies.

  • Interpretations and clarifications: Standards may be clarified or interpreted to provide additional guidance on their application.

    • Standard Numbers and Scope

    The following standard numbers and scope are relevant to the Health Canada GUI-0069 Plastic Components in Contact with Drug Products testing service:

  • ISO 10993-1:2018: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • Scope: Specifies general principles for the biological safety assessment of medical devices.

  • ASTM F739-19: Standard Test Method for Permeation of Liquids Through Polymers (Plastic Films)

    • Scope: Describes a test method for determining the permeability of plastic films to liquids.

  • EN ISO 11607-1:2019: Packaging for terminally sterilized single-use medical devices Part 1: Requirements for materials, sterilization and validation

    • Scope: Specifies requirements for packaging materials used in contact with drug products.

    Standard Compliance Requirements

    Compliance with relevant standards is essential to ensure the safety and efficacy of plastic components used in contact with drug products. Industry stakeholders must comply with standard requirements to ensure product safety and regulatory compliance.

  • Material selection: Plastic components must be made from materials that meet standard requirements.

  • Manufacturing processes: Manufacturing processes must be validated to ensure consistency and quality.

  • Testing and evaluation: Products must undergo testing and evaluation to ensure compliance with standard requirements.

    • The Health Canada GUI-0069 Plastic Components in Contact with Drug Products testing service is governed by a set of international and national standards that ensure the safety and efficacy of plastic components used in contact with drug products. The following standards are relevant to this testing service:

  • ISO 10993: Biological Evaluation of Medical Devices

  • ASTM F739: Standard Test Method for Permeation of Liquids Through Polymers (Plastic Films)

  • EN ISO 11607-1: Packaging for Terminally Sterilized Single-Use Medical Devices Part 1: Requirements for Materials, Sterilization and Validation

  • TSE L16: Packaging and Packing Materials Specifications for Plastic Components Used in Contact with Drug Products

    • These standards are developed by standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), and Turkish Standards Institution (TS).

    Standard Development Organizations

    Standard development organizations play a crucial role in developing and updating standards. These organizations work closely with industry stakeholders, regulatory bodies, and other experts to ensure that standards are relevant, effective, and up-to-date.

  • ISO: The ISO is an independent, non-governmental organization that develops voluntary international standards for various industries.

  • ASTM: The ASTM is a non-profit organization that develops consensus-based standards for materials, products, and services.

  • CEN: The CEN is the European Committee for Standardization, which develops voluntary standards for various industries.

  • TS: The TS is the Turkish Standards Institution, which develops national standards for various industries.

    • Standard Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. Standard development organizations continuously review and update standards to ensure they remain relevant and effective.

  • Revision cycles: Standards typically undergo revision cycles every 5-10 years.

  • New standard developments: New standards are developed to address emerging issues or technologies.

  • Interpretations and clarifications: Standards may be clarified or interpreted to provide additional guidance on their application.

    • Standard Numbers and Scope

    The following standard numbers and scope are relevant to the Health Canada GUI-0069 Plastic Components in Contact with Drug Products testing service:

  • ISO 10993-1:2018: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

    • Scope: Specifies general principles for the biological safety assessment of medical devices.

  • ASTM F739-19: Standard Test Method for Permeation of Liquids Through Polymers (Plastic Films)

    • Scope: Describes a test method for determining the permeability of plastic films to liquids.

  • EN ISO 11607-1:2019: Packaging for terminally sterilized single-use medical devices Part 1: Requirements for materials, sterilization and validation

    • Scope: Specifies requirements for packaging materials used in contact with drug products.

    Standard Compliance Requirements

    Compliance with relevant standards is essential to ensure the safety and efficacy of plastic components used in contact with drug products. Industry stakeholders must comply with standard requirements to ensure product safety and regulatory compliance.

  • Material selection: Plastic components must be made from materials that meet standard requirements.

  • Manufacturing processes: Manufacturing processes must be validated to ensure consistency and quality.

  • Testing and evaluation: Products must undergo testing and evaluation to ensure compliance with standard requirements.

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