EUROLAB
usp-6612-biological-reactivity-tests-for-plastic-materials
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 <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <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 <661.2> Biological Reactivity Tests for Plastic Materials Laboratory Testing Service

Standard-Related Information

The United States Pharmacopeia (USP) <661.2> Biological Reactivity Tests for Plastic Materials is a comprehensive standard that outlines the requirements for testing plastic materials used in medical devices and equipment. This standard is designed to ensure the safety and efficacy of these products by evaluating their biocompatibility and potential for adverse reactions.

Relevant Standards

  • USP <661.2> Biological Reactivity Tests for Plastic Materials

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

  • ASTM F603-14 Standard Guide for Selecting Generic Biological Test Methods for Materials and Devices

  • EN 455-3:2015 Plastics collapsible containers for injectable products - Part 3: Requirements and test methods for plastic parts in contact with the preparations

    • International and National Standards

    The USP <661.2> standard is widely recognized and adopted by regulatory authorities around the world, including:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Development Organizations

    The development of standards such as USP <661.2> is a collaborative effort between industry experts, regulatory authorities, and standard development organizations. Some notable standard development organizations include:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

    • Standard Evolution and Updates

    Standards such as USP <661.2> are regularly reviewed and updated to reflect new scientific knowledge, technological advancements, and changing regulatory requirements.

    Standard Numbers and Scope

    Some relevant standard numbers and their scope include:

  • USP <661.2> Biological Reactivity Tests for Plastic Materials

    • Applies to plastic materials used in medical devices and equipment

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

    • Provides guidance on the evaluation and testing of medical devices

    Industry-Specific Compliance Requirements

    Different industries have varying compliance requirements for USP <661.2> testing, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Cosmetic manufacturers

    • Standard-Related Challenges and Opportunities

    The development and implementation of standards such as USP <661.2> can present challenges, including:

  • Keeping pace with rapidly changing regulatory requirements

  • Ensuring compliance with multiple national and international standards

  • Addressing the need for more effective testing methods and protocols

    • However, standards also provide opportunities for innovation, improved product safety, and enhanced customer trust.

    Standard-Related Benefits

    The benefits of USP <661.2> testing include:

  • Improved product safety and efficacy

  • Enhanced customer trust and confidence

  • Compliance with regulatory requirements

  • Competitive advantages through differentiation

  • Cost savings through reduced recalls and liabilities

    • Why This Test Should Be Performed

    USP <661.2> testing is essential for ensuring the biocompatibility and safety of plastic materials used in medical devices and equipment.

    Risk Assessment and Mitigation

    The risks associated with non-compliance to USP <661.2> include:

  • Product recalls

  • Liability claims

  • Damage to reputation

    • Mitigating these risks through USP <661.2> testing can provide significant benefits, including:

  • Improved product safety

  • Reduced liability exposure

  • Enhanced customer trust and confidence

    • Quality Assurance and Compliance Benefits

    USP <661.2> testing provides a framework for ensuring quality assurance and compliance with regulatory requirements.

    Competitive Advantages and Market Positioning

    By demonstrating compliance to USP <661.2>, companies can differentiate themselves from competitors, enhance their market positioning, and improve customer trust and confidence.

    Cost Savings and Efficiency Improvements

    USP <661.2> testing can also provide cost savings through reduced recalls and liabilities, as well as efficiency improvements through streamlined testing protocols.

    Legal and Regulatory Compliance Benefits

    Compliance to USP <661.2> ensures compliance with regulatory requirements, reducing the risk of non-compliance penalties and reputational damage.

    Customer Confidence and Trust Building

    USP <661.2> testing provides a framework for building customer trust and confidence through demonstration of product safety and efficacy.

    International Market Access and Trade Facilitation

    Compliance to USP <661.2> can facilitate international market access, reducing barriers to trade and improving global supply chain management.

    Innovation and Research Development Support

    USP <661.2> testing provides a framework for innovation and research development, enabling companies to improve product safety and efficacy through advanced materials and technologies.

    Environmental and Sustainability Considerations

    The development of new plastics and materials must consider environmental and sustainability factors, including recyclability, biodegradability, and non-toxicity.

    Why Choose Our USP <661.2> Testing Service?

    Our experienced team is dedicated to providing high-quality testing services that meet or exceed regulatory requirements.

    Benefits of Choosing Our USP <661.2> Testing Service

  • Improved product safety and efficacy

  • Enhanced customer trust and confidence

  • Compliance with regulatory requirements

  • Competitive advantages through differentiation

  • Cost savings through reduced recalls and liabilities

    • Get Started with Our USP <661.2> Testing Service Today!

    Dont wait get in touch with our team today to learn more about our comprehensive testing services.

    USP <661.2> Testing FAQs

    Q: What is the purpose of USP <661.2>?

    A: The purpose of USP <661.2> is to provide a framework for ensuring the biocompatibility and safety of plastic materials used in medical devices and equipment.

    Q: Who must comply with USP <661.2>?

    A: Medical device manufacturers, pharmaceutical companies, biotechnology firms, and cosmetic manufacturers must comply with USP <661.2>.

    Q: What are the benefits of complying with USP <661.2>?

    A: The benefits of complying with USP <661.2> include improved product safety and efficacy, enhanced customer trust and confidence, compliance with regulatory requirements, competitive advantages through differentiation, cost savings through reduced recalls and liabilities.

    Q: How can I get started with USP <661.2> testing?

    A: Contact our experienced team today to learn more about our comprehensive testing services.

    Conclusion

    USP <661.2> testing is a critical component of ensuring product safety and efficacy in the medical device and equipment industry.

    References

  • United States Pharmacopeia (USP) <661.2> Biological Reactivity Tests for Plastic Materials

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

  • ASTM F603-14 Standard Guide for Selecting Generic Biological Test Methods for Materials and Devices

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