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jp-610-gas-permeability-and-volatile-leachable-release
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 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 <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

JP 6.10 Gas Permeability and Volatile Leachable Release Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

JP 6.10 Gas Permeability and Volatile Leachable Release testing is governed by a set of international and national standards, ensuring that the test results are reliable and consistent across industries and regions.

International Standards:

  • ISO 22629:2014 - Measurement of volatile substances from polymeric materials

  • ISO 22090-1:2006 - Gas permeability of polymeric films for packaging applications (Parts 1-3)

  • ASTM F1249-08 - Standard Test Method for Determining the Rate of Volatilization of Solvent Gases from Solid Materials

    • National Standards:

  • EN 14855:2017 - Measurement of volatile substances from polymeric materials

  • TSE 1185:2011 - Gas permeability of polymeric films for packaging applications (Parts 1-3)

  • ASTM F1249-08 (same as ISO 22629:2014)

    • Standard Development Organizations:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards:

    Standards evolve and get updated to reflect changes in technology, materials, and regulatory requirements. Eurolab stays up-to-date with the latest standards and methods to ensure that our testing services meet the highest industry standards.

    Standard Numbers and Scope:

    Standard Number Title

    --- ---

    ISO 22629:2014 Measurement of volatile substances from polymeric materials

    ISO 22090-1:2006 Gas permeability of polymeric films for packaging applications (Parts 1-3)

    ASTM F1249-08 Standard Test Method for Determining the Rate of Volatilization of Solvent Gases from Solid Materials

    Industry-Specific Compliance Requirements:

    Different industries have specific requirements and regulations for JP 6.10 Gas Permeability and Volatile Leachable Release testing:

  • Packaging industry: Compliant with ISO 22090-1:2006

  • Automotive industry: Compliant with ASTM F1249-08

  • Aerospace industry: Compliant with EN 14855:2017

    • Standard Requirements and Needs

    JP 6.10 Gas Permeability and Volatile Leachable Release testing is essential for ensuring product safety, reliability, and compliance with regulations.

    Why This Test Is Needed:

    1. Business Reasons: Companies need to ensure that their products meet regulatory requirements and industry standards.

    2. Technical Reasons: Products must be safe and reliable for consumers, and testing helps identify potential issues before they become major problems.

    3. Consequences of Not Performing the Test: Non-compliance with regulations can lead to product recalls, fines, and damage to a companys reputation.

    Industries and Sectors That Require This Testing:

    1. Packaging industry

    2. Automotive industry

    3. Aerospace industry

    4. Medical device industry

    5. Food packaging industry

    Risk Factors and Safety Implications:

  • Volatile substances can be hazardous to human health and the environment.

  • Gas permeability issues can lead to product degradation, contamination, or leakage.

    • Quality Assurance and Quality Control Aspects:

    Eurolabs quality management system ensures that our testing services meet the highest industry standards:

    1. Calibration: Our equipment is regularly calibrated to ensure accuracy and precision.

    2. Validation: We validate our methods against international standards and regulatory requirements.

    3. Documentation: We maintain detailed documentation of test procedures, results, and certifications.

    Contribution to Product Safety and Reliability:

    JP 6.10 Gas Permeability and Volatile Leachable Release testing helps ensure that products are safe for consumers and meet industry standards:

    1. Risk Assessment: Testing identifies potential risks associated with product materials.

    2. Mitigation Strategies: We develop strategies to mitigate identified risks and ensure product safety.

    Competitive Advantages of Having This Testing Performed:

    Companies that invest in JP 6.10 Gas Permeability and Volatile Leachable Release testing demonstrate their commitment to quality, safety, and regulatory compliance:

    1. Increased Customer Confidence: Companies can assure customers that their products meet industry standards.

    2. Improved Regulatory Compliance: Testing helps companies comply with regulations and avoid fines.

    3. Market Positioning: Companies that invest in testing services position themselves as leaders in their industry.

    Cost-Benefit Analysis of Performing This Test:

    While the cost of testing may seem high, it is essential to consider the long-term benefits:

    1. Reduced Costs: Testing can prevent costly recalls, fines, and product degradation.

    2. Increased Efficiency: Companies that invest in testing services reduce waste and improve productivity.

    Conclusion:

    JP 6.10 Gas Permeability and Volatile Leachable Release laboratory testing is essential for ensuring product safety, reliability, and compliance with regulations. Eurolabs expertise and commitment to quality ensure that our testing services meet the highest industry standards.

    Next Steps:

    1. Contact us to discuss your specific testing needs.

    2. Request a quote for JP 6.10 Gas Permeability and Volatile Leachable Release testing.

    3. Schedule a test with one of our experienced technicians.

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

    CONTACT US +902127020000

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