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usp-671-stability-and-buffering-capacity-in-plastic-containers
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 <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <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 <671> Stability and Buffering Capacity in Plastic Containers Laboratory Testing Service: A Comprehensive Guide

As a leading laboratory testing service provider, Eurolab offers a range of testing services to ensure the quality and safety of plastic containers used for pharmaceutical products. In this article, we will provide a comprehensive guide to USP <671> Stability and Buffering Capacity in Plastic Containers laboratory testing service, including standard-related information, standard requirements and needs, test conditions and methodology, test reporting and documentation, benefits of performing this test, and why Eurolab should be your partner for this service.

The United States Pharmacopeia (USP) <671> Stability and Buffering Capacity in Plastic Containers is a standard that provides guidelines for testing the stability and buffering capacity of plastic containers used for pharmaceutical products. This standard is based on international standards such as ISO, ASTM, EN, and TSE, which provide guidelines for testing the physical, chemical, and biological properties of materials.

International and National Standards

The following are some of the key international and national standards that apply to USP <671> Stability and Buffering Capacity in Plastic Containers testing:

  • ISO 11607: Packaging for Terminally Sterilized Medical Devices

  • ASTM F838-05: Standard Guide for Testing the Compatibility of Materials with Blood

  • EN 1603: Plastics - Determination of the effect of gamma radiation on some properties of plastics

  • TSE L6: Plastic Containers for Pharmaceutical Products

    • Standard Development Organizations

    The following are some of the key standard development organizations that contribute to the development and maintenance of standards related to USP <671> Stability and Buffering Capacity in Plastic Containers testing:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution and Update

    Standards evolve over time as new technologies, materials, and techniques are developed. The standard development organizations work together to update and revise standards to reflect the latest research and findings.

    Specific Standard Numbers and Their Scope

    The following are some of the specific standard numbers and their scope:

  • ISO 11607: Packaging for Terminally Sterilized Medical Devices

    • Scope: This standard provides guidelines for testing the packaging materials used for terminally sterilized medical devices.

  • ASTM F838-05: Standard Guide for Testing the Compatibility of Materials with Blood

    • Scope: This standard provides guidelines for testing the compatibility of materials with blood.

    Standard Compliance Requirements

    The following are some of the key industries and sectors that require compliance with USP <671> Stability and Buffering Capacity in Plastic Containers testing:

  • Pharmaceutical industry

  • Medical device industry

  • Food and beverage industry

    • Consequences of Non-Compliance

    Failure to comply with USP <671> Stability and Buffering Capacity in Plastic Containers testing can result in product recalls, fines, and damage to reputation.

    The following are some of the key reasons why USP <671> Stability and Buffering Capacity in Plastic Containers testing is required:

  • Product Safety: This test ensures that plastic containers used for pharmaceutical products do not leach chemicals or other substances into the product, which can harm patients.

  • Regulatory Compliance: This test ensures compliance with international and national standards such as ISO 11607, ASTM F838-05, EN 1603, and TSE L6.

  • Quality Assurance: This test ensures that plastic containers used for pharmaceutical products meet the required quality standards.

    • Business and Technical Reasons

    The following are some of the key business and technical reasons why USP <671> Stability and Buffering Capacity in Plastic Containers testing is conducted:

  • Product Liability: Manufacturers can be held liable if their products cause harm to patients.

  • Quality Control: This test ensures that plastic containers used for pharmaceutical products meet the required quality standards.

  • Cost Savings: Conducting this test early on can save costs associated with product recalls and fines.

    • Consequences of Not Performing This Test

    Failure to perform USP <671> Stability and Buffering Capacity in Plastic Containers testing can result in product recalls, fines, and damage to reputation.

    Industries and Sectors That Require This Testing

    The following are some of the key industries and sectors that require this testing:

  • Pharmaceutical industry

  • Medical device industry

  • Food and beverage industry

    • Risk Factors and Safety Implications

    The following are some of the key risk factors and safety implications associated with USP <671> Stability and Buffering Capacity in Plastic Containers testing:

  • Product Contamination: Plastic containers can leach chemicals or other substances into the product, which can harm patients.

  • Regulatory Non-Compliance: Failure to comply with international and national standards such as ISO 11607, ASTM F838-05, EN 1603, and TSE L6.

    • The following are some of the key test conditions and methodology associated with USP <671> Stability and Buffering Capacity in Plastic Containers testing:

  • Sample Preparation: Samples of plastic containers are prepared for testing.

  • Testing Methods: The testing methods used include chemical, physical, and biological tests to determine the stability and buffering capacity of plastic containers.

    • The following are some of the key test reporting and documentation requirements associated with USP <671> Stability and Buffering Capacity in Plastic Containers testing:

  • Test Reports: Test reports must be provided to customers, detailing the results of the testing.

  • Documentation: Documentation must be maintained, including records of sample preparation, testing methods, and results.

    • Benefits of Performing This Test

    The following are some of the key benefits associated with performing USP <671> Stability and Buffering Capacity in Plastic Containers testing:

  • Product Safety: This test ensures that plastic containers used for pharmaceutical products do not leach chemicals or other substances into the product.

  • Regulatory Compliance: This test ensures compliance with international and national standards such as ISO 11607, ASTM F838-05, EN 1603, and TSE L6.

  • Quality Assurance: This test ensures that plastic containers used for pharmaceutical products meet the required quality standards.

    • Why Choose Eurolab

    The following are some of the key reasons why you should choose Eurolab for USP <671> Stability and Buffering Capacity in Plastic Containers testing:

  • Expertise: Our team has extensive experience in testing plastic containers used for pharmaceutical products.

  • Equipment: We have state-of-the-art equipment to ensure accurate and reliable results.

  • Quality Assurance: We maintain strict quality control measures to ensure compliance with international and national standards.

    • In conclusion, USP <671> Stability and Buffering Capacity in Plastic Containers laboratory testing service is an essential requirement for ensuring the safety and efficacy of pharmaceutical products. By choosing Eurolab, you can be confident that your plastic containers meet the required quality standards, ensuring product safety and regulatory compliance.

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