EUROLAB
usp-6611-physicochemical-testing-of-plastic-packaging-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 <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <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 <661.1> Physicochemical Testing of Plastic Packaging Systems: A Comprehensive Guide to Eurolabs Laboratory Testing Service

The United States Pharmacopeia (USP) <661.1> standard outlines the requirements for physicochemical testing of plastic packaging systems. This standard is crucial in ensuring the safety and efficacy of pharmaceutical products by evaluating the chemical properties of plastic materials used in packaging.

Relevant Standards

  • ISO 11607-1:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems

  • ASTM F88/F88M-19 Standard Practice for Design of Laboratory Tests to Assess the Resistance of Medical Devices to Steaming Using an Autoclave Sterilizer

  • EN 868-4:2014 Plastics materials and articles - Thermoplastic components for medical devices - Part 4: Materials requirements for non-sterile thermoplastics

  • TSE (Turkish Standards Institution) ISO/TS 16679:2013 Medical equipment -- Packaging systems for single-use medical instruments

    • Legal and Regulatory Framework

    The USP <661.1> standard is enforced by regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada. Compliance with this standard ensures that pharmaceutical products meet international safety and efficacy standards.

    International and National Standards

  • ISO 11607-1:2016 is an international standard applicable to medical devices

  • EN 868-4:2014 is a European standard for thermoplastic components in medical devices

  • TSE (Turkish Standards Institution) ISO/TS 16679:2013 is a Turkish standard for packaging systems of single-use medical instruments

    • Standard Development Organizations

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution and Updates

    Standards evolve through continuous review, revision, and update by standard development organizations. The USP <661.1> standard has undergone several revisions since its initial publication in 2012.

    Standard Numbers and Scope

  • USP <661.1>

    • Scope: Physicochemical testing of plastic packaging systems

    Requirements: Chemical resistance, extractable substances, migration, and permeability

    Industry-Specific Compliance Requirements

    Pharmaceutical manufacturers must comply with the USP <661.1> standard to ensure their products meet international safety and efficacy standards.

    The USP <661.1> standard is essential for ensuring the safety and efficacy of pharmaceutical products by evaluating the chemical properties of plastic materials used in packaging.

    Business and Technical Reasons

    Pharmaceutical manufacturers require this testing to:

  • Ensure compliance with international standards

  • Protect consumer safety and health

  • Maintain product quality and reliability

  • Enhance brand reputation and market positioning

    • Consequences of Not Performing This Test

    Failure to comply with the USP <661.1> standard can result in:

  • Product recalls and withdrawals

  • Loss of business and revenue

  • Damage to reputation and credibility

  • Non-compliance with regulatory requirements

    • Industries and Sectors

    Pharmaceutical manufacturers, medical device manufacturers, and packaging suppliers are subject to this testing requirement.

    Risk Factors and Safety Implications

    The USP <661.1> standard addresses potential risks associated with plastic packaging materials, including:

  • Chemical migration and leaching

  • Extractable substances and contaminants

  • Permeability and gas transmission

    • Quality Assurance and Quality Control Aspects

    Compliance with the USP <661.1> standard requires:

  • Regular testing and evaluation of plastic packaging materials

  • Implementation of quality management systems (QMS)

  • Compliance with regulatory requirements and industry standards

    • Contributions to Product Safety and Reliability

    The USP <661.1> standard contributes to product safety and reliability by:

  • Evaluating the chemical properties of plastic materials

  • Ensuring compliance with international standards

  • Protecting consumer health and safety

    • Competitive Advantages and Cost-Benefit Analysis

    Performing this testing can provide competitive advantages, including:

  • Enhanced brand reputation and market positioning

  • Compliance with regulatory requirements and industry standards

  • Improved product quality and reliability

  • Cost savings through reduced product recalls and withdrawals

    • The USP <661.1> standard outlines the testing conditions and methodology for evaluating the chemical properties of plastic materials used in packaging.

    Step-by-Step Explanation

    1. Sample preparation: Collecting, preparing, and storing the test samples

    2. Testing equipment: Using instruments such as high-performance liquid chromatography (HPLC) and gas chromatography-mass spectrometry (GC-MS)

    3. Testing conditions: Evaluating chemical resistance, extractable substances, migration, and permeability under various conditions

    Instrumentation and Equipment

  • HPLC for evaluating extractable substances

  • GC-MS for evaluating migratable substances

  • Permeation cells for evaluating gas transmission

    • Testing Conditions

  • Chemical resistance testing: Evaluating the materials ability to withstand exposure to chemicals

  • Extractable substances testing: Evaluating the presence of contaminants in the packaging material

  • Migration testing: Evaluating the transfer of substances from the packaging material to the product

  • Permeability testing: Evaluating gas transmission through the packaging material

    • Data Interpretation and Reporting

    Results are interpreted according to the USP <661.1> standard, and reports must include detailed information on test conditions, equipment used, and results.

    Conclusion

    The USP <661.1> standard is a crucial requirement for ensuring the safety and efficacy of pharmaceutical products by evaluating the chemical properties of plastic materials used in packaging. Compliance with this standard is essential for maintaining product quality and reliability, protecting consumer health and safety, and enhancing brand reputation and market positioning.

    Recommendations

    Pharmaceutical manufacturers should:

  • Familiarize themselves with the USP <661.1> standard

  • Implement regular testing and evaluation of plastic packaging materials

  • Develop a QMS to ensure compliance with regulatory requirements and industry standards

    • By following these recommendations, pharmaceutical manufacturers can ensure their products meet international safety and efficacy standards, protecting consumer health and safety while maintaining product quality and reliability.

    Additional Resources

    For more information on the USP <661.1> standard, please refer to the United States Pharmacopeia website or consult with a qualified testing laboratory.

    ---

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers