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usp-1661-evaluation-of-plastic-packaging-systems-for-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 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 <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 USP <1661> Evaluation of Plastic Packaging Systems for Drug Products Laboratory Testing Service

Standard-Related Information

The United States Pharmacopeia (USP) <1661> Evaluation of Plastic Packaging Systems for Drug Products is a comprehensive standard that outlines the requirements and testing procedures for evaluating the suitability of plastic packaging systems for drug products. This standard is designed to ensure the safety, efficacy, and quality of pharmaceuticals by ensuring that their packaging meets specific standards.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing is governed by various international and national standards, including:

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

  • ASTM F2393-08 Standard Practice for Testing the Compatibility of Materials with Blood

  • EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

  • TSE L (Turkish Standards Institution) No. 1661: Evaluation of plastic packaging systems for drug products

    • International and National Standards

    The following international and national standards apply to USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing:

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

  • ASTM F2393-08 Standard Practice for Testing the Compatibility of Materials with Blood

  • EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

  • TSE L (Turkish Standards Institution) No. 1661: Evaluation of plastic packaging systems for drug products

    • Standard Development Organizations

    Standard development organizations play a crucial role in developing and maintaining standards for USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing. These organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution and Updates

    Standards evolve and get updated to reflect new technologies, scientific discoveries, and regulatory requirements. The standard development process involves:

  • Identifying the need for a new or revised standard

  • Conducting research and gathering data

  • Developing a draft standard

  • Reviewing and revising the draft standard

  • Finalizing the standard

    • Standard Numbers and Scope

    The following standard numbers and their scope apply to USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing:

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

    • Scope: This part of ISO 10993 provides a framework for evaluating the biological safety of medical devices.

  • ASTM F2393-08 Standard Practice for Testing the Compatibility of Materials with Blood

    • Scope: This standard provides a practice for testing the compatibility of materials with blood and other bodily fluids.

  • EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

    • Scope: This part of EN ISO 10993 provides tests for in vitro cytotoxicity.

    Standard Compliance Requirements

    Standard compliance requirements vary depending on the industry and sector. For USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing, compliance is required for:

  • Pharmaceuticals

  • Medical devices

  • Food packaging

    • Standard-Related Costs

    The costs associated with standard compliance can be significant, but they are necessary to ensure product safety and regulatory compliance.

    Standard-Related Benefits

    The benefits of standard compliance include:

  • Improved product safety

  • Enhanced regulatory compliance

  • Increased customer confidence

  • Competitive advantage in the market

    • ---

    Standard Requirements and Needs

    USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing is necessary to ensure that plastic packaging systems meet specific standards. The business and technical reasons for conducting this test include:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Maintaining customer confidence and trust

  • Competing in the market

    • Consequences of Not Performing the Test

    The consequences of not performing USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing can be severe, including:

  • Product recalls

  • Regulatory penalties

  • Loss of customer trust

  • Damage to reputation and brand image

    • Industries and Sectors Requiring Testing

    USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing is required for various industries and sectors, including:

  • Pharmaceuticals

  • Medical devices

  • Food packaging

    • Risk Factors and Safety Implications

    The risk factors and safety implications associated with USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing include:

  • Toxicity to humans and animals

  • Environmental impact

  • Inadequate packaging performance

    • ---

    Standard-Related Procedures

    USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing involves the following procedures:

  • Sample preparation

  • Testing for physical properties (e.g., tensile strength, flexibility)

  • Testing for chemical properties (e.g., pH, extractables)

  • Testing for biological properties (e.g., cytotoxicity, irritation)

    • Standard-Related Equipment and Materials

    The equipment and materials required for USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing include:

  • Material testing machines

  • Analytical instruments (e.g., GC, HPLC)

  • Biological testing systems

    • ---

    Conclusion

    USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing is a critical standard that ensures the safety and efficacy of plastic packaging systems. Compliance with this standard requires a thorough understanding of the standard requirements, procedures, and equipment.

    Recommendations

    To ensure compliance with USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing, we recommend:

  • Reviewing and implementing relevant standards

  • Developing and maintaining quality management systems

  • Providing ongoing training to personnel involved in testing

  • Maintaining accurate records of testing results and certifications

    • ---

    Standard-Related Resources

    For further information on USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing, please refer to the following resources:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • ---

    Appendix

    The following appendix provides additional resources and references related to USP <1661> Evaluation of Plastic Packaging Systems for Drug Products testing:

  • List of standard numbers and their scope

  • Standard development organizations

  • Standard evolution and updates

  • Standard-related costs and benefits

    • Please refer to the appendix for more information.

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