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usp-1663-extractables-testing-for-plastic-components-in-drug-packaging
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 <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

USP <1663> Extractables Testing for Plastic Components in Drug Packaging: A Comprehensive Guide

Standard-Related Information

USP <1663> Extractables Testing for Plastic Components in Drug Packaging is a critical laboratory testing service that ensures the safety and quality of pharmaceutical products packaged in plastic components. This article provides a comprehensive overview of the relevant standards, regulatory framework, and industry requirements governing this testing service.

The US Pharmacopeia (USP) is a non-profit organization responsible for establishing standards for the pharmaceutical industry. USP <1663> Extractables Testing for Plastic Components in Drug Packaging is a mandatory requirement for all plastic components used in packaging of pharmaceutical products. The standard outlines the procedures and methods for evaluating extractables from plastic components, ensuring that they do not leach into the product.

Regulatory Framework

The regulatory framework surrounding USP <1663> Extractables Testing for Plastic Components in Drug Packaging is governed by international and national standards. Some of the key standards include:

  • ISO 10993-1:2009 - Biological evaluation of medical devices

  • ASTM F739-12 - Standard test method for permeation resistance of protective materials used for chemical cartridge respirators

  • EN 71:2011 - Safety of toys

  • TSE (Turkish Standards Institution) 13424:2020 - Packaging requirements

    • International and National Standards

    The international standards governing USP <1663> Extractables Testing for Plastic Components in Drug Packaging are:

  • ISO 10993-1:2009 - Biological evaluation of medical devices

  • ASTM F739-12 - Standard test method for permeation resistance of protective materials used for chemical cartridge respirators

    • National standards include:

  • EN 71:2011 - Safety of toys (EU)

  • TSE (Turkish Standards Institution) 13424:2020 - Packaging requirements (Turkey)

    • Standard Development Organizations

    The standard development organizations responsible for USP <1663> Extractables Testing for Plastic Components in Drug Packaging are:

  • US Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulations, or industry practices. Updates to standards ensure that the testing service remains relevant and effective.

    Specific Standard Numbers and Scope

    Some specific standard numbers and their scope include:

  • USP <1663> Extractables Testing for Plastic Components in Drug Packaging: Evaluates extractables from plastic components

  • ISO 10993-1:2009 - Biological evaluation of medical devices: Provides general requirements for biological evaluations

  • ASTM F739-12 - Standard test method for permeation resistance of protective materials used for chemical cartridge respirators: Evaluates permeation resistance of protective materials

    • Standard Compliance Requirements

    Compliance with standards is mandatory for industries that require USP <1663> Extractables Testing for Plastic Components in Drug Packaging. Failure to comply may result in product recalls, fines, or even litigation.

    Standard-Related Information Conclusion

    USP <1663> Extractables Testing for Plastic Components in Drug Packaging is a critical laboratory testing service governed by international and national standards. Compliance with these standards ensures the safety and quality of pharmaceutical products packaged in plastic components.

    Standard Requirements and Needs

    The specific test requirements for USP <1663> Extractables Testing for Plastic Components in Drug Packaging include:

  • Evaluating extractables from plastic components

  • Ensuring that extractables do not leach into the product

  • Complying with international and national standards

    • Business and Technical Reasons for Conducting USP <1663>

    Conducting USP <1663> Extractables Testing for Plastic Components in Drug Packaging is essential for several reasons:

    1. Ensuring Product Safety: Extractables from plastic components can leach into pharmaceutical products, posing risks to human health.

    2. Compliance with Regulations: Failing to comply with standards may result in product recalls, fines, or even litigation.

    3. Quality Assurance and Quality Control: Conducting USP <1663> Extractables Testing for Plastic Components in Drug Packaging ensures that products meet regulatory requirements.

    Consequences of Not Performing This Test

    Failure to perform USP <1663> Extractables Testing for Plastic Components in Drug Packaging may result in:

  • Product recalls

  • Fines or penalties

  • Litigation and potential financial losses

    • Industries and Sectors Requiring This Testing

    USP <1663> Extractables Testing for Plastic Components in Drug Packaging is required for industries that use plastic components in packaging of pharmaceutical products, including:

  • Pharmaceutical companies

  • Medical device manufacturers

  • Cosmetic companies

  • Food industry suppliers

    • Risk Factors and Safety Implications

    The risk factors associated with extractables from plastic components include:

  • Health risks to humans due to leaching into pharmaceutical products

  • Damage to reputation and brand image

  • Financial losses due to product recalls, fines, or litigation

    • Standard Requirements and Needs Conclusion

    Conducting USP <1663> Extractables Testing for Plastic Components in Drug Packaging is essential for ensuring product safety, compliance with regulations, quality assurance, and quality control.

    Standard-Related Information Conclusion

    USP <1663> Extractables Testing for Plastic Components in Drug Packaging is a critical laboratory testing service governed by international and national standards. Compliance with these standards ensures the safety and quality of pharmaceutical products packaged in plastic components.

    Insert next section

    Standard Requirements and Needs

    The specific test requirements for USP <1663> Extractables Testing for Plastic Components in Drug Packaging include:

  • Evaluating extractables from plastic components

  • Ensuring that extractables do not leach into the product

  • Complying with international and national standards

    • Business and Technical Reasons for Conducting USP <1663>

    Conducting USP <1663> Extractables Testing for Plastic Components in Drug Packaging is essential for several reasons:

    1. Ensuring Product Safety: Extractables from plastic components can leach into pharmaceutical products, posing risks to human health.

    2. Compliance with Regulations: Failing to comply with standards may result in product recalls, fines, or even litigation.

    3. Quality Assurance and Quality Control: Conducting USP <1663> Extractables Testing for Plastic Components in Drug Packaging ensures that products meet regulatory requirements.

    Consequences of Not Performing This Test

    Failure to perform USP <1663> Extractables Testing for Plastic Components in Drug Packaging may result in:

  • Product recalls

  • Fines or penalties

  • Litigation and potential financial losses

    • Industries and Sectors Requiring This Testing

    USP <1663> Extractables Testing for Plastic Components in Drug Packaging is required for industries that use plastic components in packaging of pharmaceutical products, including:

  • Pharmaceutical companies

  • Medical device manufacturers

  • Cosmetic companies

  • Food industry suppliers

    • Risk Factors and Safety Implications

    The risk factors associated with extractables from plastic components include:

  • Health risks to humans due to leaching into pharmaceutical products

  • Damage to reputation and brand image

  • Financial losses due to product recalls, fines, or litigation

    • Standard Requirements and Needs Conclusion

    Conducting USP <1663> Extractables Testing for Plastic Components in Drug Packaging is essential for ensuring product safety, compliance with regulations, quality assurance, and quality control.

    Insert next section

    Testing Methods and Procedures

    The testing methods and procedures for USP <1663> Extractables Testing for Plastic Components in Drug Packaging include:

  • Evaluating extractables from plastic components using analytical techniques such as chromatography or spectroscopy

  • Ensuring that extractables do not leach into the product by evaluating permeation rates

    • Analytical Techniques

    Some common analytical techniques used in USP <1663> Extractables Testing for Plastic Components in Drug Packaging include:

  • High-Performance Liquid Chromatography (HPLC)

  • Gas Chromatography-Mass Spectrometry (GC-MS)

    • Testing Procedures and Protocols

    The testing procedures and protocols for USP <1663> Extractables Testing for Plastic Components in Drug Packaging include:

  • Evaluating extractables from plastic components using standardized methods

  • Ensuring that testing is performed by qualified personnel

    • Quality Control Measures

    Some quality control measures used in USP <1663> Extractables Testing for Plastic Components in Drug Packaging include:

  • Verifying the identity and purity of test samples

  • Ensuring that testing is performed using validated analytical techniques

    • Insert next section

    Testing Methods and Procedures Conclusion

    The testing methods and procedures for USP <1663> Extractables Testing for Plastic Components in Drug Packaging are essential for ensuring product safety, compliance with regulations, quality assurance, and quality control.

    Insert next section

    Industry Best Practices

    Some industry best practices for conducting USP <1663> Extractables Testing for Plastic Components in Drug Packaging include:

  • Implementing a comprehensive testing program that covers all plastic components

  • Ensuring that testing is performed by qualified personnel using validated analytical techniques

    • Regulatory Guidelines and Recommendations

    Regulatory guidelines and recommendations for USP <1663> Extractables Testing for Plastic Components in Drug Packaging include:

  • Ensuring compliance with international and national standards

    • Insert next section

    Industry Best Practices Conclusion

    Implementing industry best practices for conducting USP <1663> Extractables Testing for Plastic Components in Drug Packaging is essential for ensuring product safety, compliance with regulations, quality assurance, and quality control.

    Insert next section

    Conclusion

    USP <1663> Extractables Testing for Plastic Components in Drug Packaging is a critical laboratory testing service governed by international and national standards. Compliance with these standards ensures the safety and quality of pharmaceutical products packaged in plastic components.

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