EUROLAB
jp-702-residual-solvent-and-leachable-identification
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 7.04 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 7.02 Residual Solvent and Leachable Identification Laboratory Testing Service: A Comprehensive Guide

The JP 7.02 Residual Solvent and Leachable Identification testing service provided by Eurolab is governed by various international and national standards. These standards ensure that the test results are accurate, reliable, and compliant with regulatory requirements.

International Standards

  • ISO 11662-1:2015 - Plastic packaging materials for measurement of gases exchanged through the walls of containers

  • ISO 10993-18:2018 - Biological evaluation of medical devices Part 18: Chemical characterization of biological systems in contact with a medical device

  • ASTM F2003-08(2020) - Standard Test Method for Determination of Leachable Components from Plastics Used in Medical Devices

    • National Standards

  • EN 1662:2016 - Plastic materials and articles Methods for determining the content of volatile organic compounds

  • TSE 1151:2018 - Plastic packaging materials for measurement of gases exchanged through the walls of containers

  • ASTM F1930-16(2020) - Standard Test Method for Determination of Leachable Components from Plastics Used in Medical Devices

    • Standard Development Organizations

    Eurolab adheres to the standards developed by various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations play a crucial role in developing, maintaining, and revising standards to ensure that they remain relevant and effective.

    Standard Evolution and Update

    Standards evolve as new technologies and research emerge. Eurolab stays up-to-date with the latest developments and updates its testing procedures accordingly. This ensures that customers receive accurate and reliable test results.

    Standard Numbers and Scope

    The following table provides an overview of the standards mentioned above:

    Standard Number Title Scope

    --- --- ---

    ISO 11662-1:2015 Plastic packaging materials for measurement of gases exchanged through the walls of containers Defines methods for determining volatile organic compounds (VOCs) in plastic packaging materials.

    ISO 10993-18:2018 Biological evaluation of medical devices Part 18: Chemical characterization of biological systems in contact with a medical device Provides guidelines for assessing the chemical properties of medical devices.

    ASTM F2003-08(2020) Standard Test Method for Determination of Leachable Components from Plastics Used in Medical Devices Describes methods for determining leachable components from plastics used in medical devices.

    Industry-Specific Compliance Requirements

    Different industries have varying compliance requirements for JP 7.02 Residual Solvent and Leachable Identification testing:

  • Medical device manufacturers must comply with ISO 10993-18:2018.

  • Pharmaceutical companies must adhere to ASTM F2003-08(2020).

  • Cosmetic manufacturers should follow the guidelines outlined in EN 1662:2016.

    • Why This Test is Needed and Required

    JP 7.02 Residual Solvent and Leachable Identification testing is essential for ensuring product safety, regulatory compliance, and customer satisfaction. The test helps identify potential hazards associated with residual solvents and leachables in products.

    Business and Technical Reasons for Conducting the Test

  • Regulatory compliance: Companies must comply with industry-specific regulations and standards.

  • Product safety: Testing ensures that products do not pose any health risks to consumers.

  • Quality assurance: Regular testing helps maintain product quality and consistency.

    • Consequences of Not Performing the Test

    Failure to conduct JP 7.02 Residual Solvent and Leachable Identification testing can result in:

  • Regulatory fines and penalties

  • Product recalls

  • Damage to brand reputation

  • Loss of customer trust

    • Industries and Sectors Requiring This Testing

    The following industries require JP 7.02 Residual Solvent and Leachable Identification testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Cosmetic manufacturers

  • Food packaging industry

    • Risk Factors and Safety Implications

    JP 7.02 Residual Solvent and Leachable Identification testing helps identify potential risks associated with residual solvents and leachables, such as:

  • Health hazards to consumers

  • Environmental impact

  • Product contamination

    • Quality Assurance and Control Aspects

    Eurolabs quality assurance and control procedures ensure that the testing service meets industry-specific standards and regulatory requirements.

    Step-by-Step Explanation of the Test

    JP 7.02 Residual Solvent and Leachable Identification testing involves the following steps:

    1. Sample preparation

    2. Instrument calibration

    3. Testing parameters setup

    4. Data collection and analysis

    5. Reporting and documentation

    Testing Equipment and Instruments

    Eurolab uses state-of-the-art equipment, including:

  • Gas chromatography-mass spectrometry (GC-MS)

  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    • Sample Preparation

    Samples are prepared according to industry-specific standards and regulations.

    Instrument Calibration

    Instruments are calibrated regularly to ensure accuracy and reliability of test results.

    Reporting and Documentation

    Test reports include detailed information on:

  • Test parameters

  • Results

  • Conclusion and recommendations

    • Reports are presented in a clear, concise manner, ensuring that customers understand the findings.

    Conclusion

    JP 7.02 Residual Solvent and Leachable Identification testing is essential for ensuring product safety, regulatory compliance, and customer satisfaction. Eurolabs expertise and state-of-the-art equipment ensure accurate and reliable test results.

    Please note that this guide provides a general overview of the JP 7.02 Residual Solvent and Leachable Identification testing service. For specific information and requirements, please consult with Eurolab representatives or relevant industry standards and regulations.

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