EUROLAB
jp-704-containerclosure-leachable-migration-evaluation
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 IdentificationPDA 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 7.04 Container/Closure Leachable Migration Evaluation Laboratory Testing Service

A Comprehensive Guide to Eurolabs Expertise in Ensuring Product Safety and Reliability

The JP 7.04 Container/Closure Leachable Migration Evaluation testing service provided by Eurolab is governed by a range of international and national standards. The primary standard that governs this testing is the ISO 11607-1:2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems. This standard outlines the requirements for packaging systems used in the sterilization of medical devices.

In addition to the ISO 11607-1:2019 standard, Eurolab also adheres to the ISO 10993-18:2020, Biological evaluation of medical devices - Part 18: Chemical characterization of materials. This standard provides guidelines for the chemical characterization of materials used in medical devices.

Other relevant standards that govern this testing service include:

  • ASTM F1929-19: Standard Test Method for Leachable Extractables from Medical Devices (2019)

  • EN ISO 11607-1:2018, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

  • TSE 1170:2013, Package of the Sterilization System to be Used in Medicine and Medical Equipment

    • Eurolab is committed to complying with these standards and ensuring that its testing services meet the highest level of quality and accuracy.

    Standard Development Organizations and their Role

    The development of international standards for JP 7.04 Container/Closure Leachable Migration Evaluation testing is overseen by a range of standard development organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations work together to develop and maintain standards that ensure consistency and quality in the testing and evaluation of medical devices.

    Evolution of Standards

    Standards for JP 7.04 Container/Closure Leachable Migration Evaluation testing are regularly reviewed and updated to reflect advances in technology and changes in regulatory requirements. Eurolab stays up-to-date with the latest standards and guidelines, ensuring that its testing services remain current and compliant.

    Standard Numbers and Scope

    The following standard numbers and their scope apply to JP 7.04 Container/Closure Leachable Migration Evaluation testing:

  • ISO 11607-1:2019 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems

  • ISO 10993-18:2020 - Biological evaluation of medical devices - Part 18: Chemical characterization of materials

    • Industry-Specific Examples and Case Studies

    Eurolab has extensive experience in providing JP 7.04 Container/Closure Leachable Migration Evaluation testing services to a range of industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Food packaging producers

    • Case studies are available upon request, demonstrating Eurolabs expertise and commitment to delivering high-quality testing services.

    Standard Compliance Requirements for Different Industries

    Different industries have varying standard compliance requirements. For example:

  • Medical device manufacturers must comply with ISO 11607-1:2019 and ISO 10993-18:2020

  • Pharmaceutical companies must comply with USP <87> and <88>

    • Eurolab is familiar with these requirements and ensures that its testing services meet the specific needs of each industry.

    The JP 7.04 Container/Closure Leachable Migration Evaluation testing service provided by Eurolab is essential for ensuring product safety and reliability in a range of industries.

    Why This Test Is Needed

    This test is necessary to evaluate the potential risks associated with leachable migration from container/closure systems. Failure to conduct this testing can result in:

  • Product recalls

  • Customer complaints

  • Loss of business reputation

    • Business and Technical Reasons for Conducting JP 7.04 Container/Closure Leachable Migration Evaluation Testing

    The primary reasons for conducting this test are:

  • To ensure compliance with regulatory requirements (e.g., ISO 11607-1:2019, ISO 10993-18:2020)

  • To minimize the risk of product recalls and customer complaints

  • To protect business reputation and maintain market share

    • Consequences of Not Performing This Test

    Failure to conduct this test can result in:

  • Product contamination

  • Adverse health effects

  • Financial losses due to product recall or litigation

    • Industries and Sectors That Require This Testing

    The following industries and sectors require JP 7.04 Container/Closure Leachable Migration Evaluation testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Food packaging producers

  • Cosmetics and personal care products manufacturers

    • Risk Factors and Safety Implications

    Leachable migration from container/closure systems can pose significant risks to human health, including:

  • Chemical contamination of medical devices or pharmaceuticals

  • Adverse reactions or allergic responses in patients

  • Product recalls and financial losses

    • Eurolab is committed to helping clients mitigate these risks through its JP 7.04 Container/Closure Leachable Migration Evaluation testing services.

    Testing Requirements and Procedures

    The testing requirements for JP 7.04 Container/Closure Leachable Migration Evaluation involve:

    1. Sample preparation

    2. Extraction of leachables from container/closure systems

    3. Analytical techniques (e.g., HPLC, GC-MS) to detect and quantify leachables

    Eurolabs experienced team ensures that all testing is conducted according to established protocols and standards.

    Indicators for Leachable Migration

    Leachable migration can be indicated by:

  • Chemical contaminants in packaging materials

  • Adverse health effects or complaints from users

  • Non-compliance with regulatory requirements (e.g., ISO 11607-1:2019, ISO 10993-18:2020)

    • Eurolabs testing services help identify potential leachable migration and mitigate risks associated with product contamination.

    Standard Requirements for Packaging Systems

    Packaging systems used in medical devices or pharmaceuticals must meet the following standard requirements:

  • Compliance with regulatory requirements (e.g., ISO 11607-1:2019, ISO 10993-18:2020)

  • Material selection to minimize leachable migration

  • Design and testing of packaging systems to ensure safe and efficient sterilization

    • Eurolab ensures that all testing services meet these standard requirements.

    Conclusion

    JP 7.04 Container/Closure Leachable Migration Evaluation testing is essential for ensuring product safety and reliability in a range of industries. Eurolabs expertise and commitment to delivering high-quality testing services make it the ideal partner for clients seeking to minimize risks associated with leachable migration from container/closure systems.

    Testing Services

    Eurolab provides comprehensive JP 7.04 Container/Closure Leachable Migration Evaluation testing services, including:

  • Sample preparation

  • Extraction of leachables from container/closure systems

  • Analytical techniques (e.g., HPLC, GC-MS) to detect and quantify leachables

    • Our experienced team ensures that all testing is conducted according to established protocols and standards.

    Certification and Compliance

    Eurolabs JP 7.04 Container/Closure Leachable Migration Evaluation testing services are certified to the following standards:

  • ISO/IEC 17025:2017

  • ISO 13485:2016

    • We guarantee compliance with regulatory requirements (e.g., ISO 11607-1:2019, ISO 10993-18:2020) and industry-specific standards.

    Consultation and Expertise

    Eurolabs team of experts provides consultation services to help clients understand the requirements for JP 7.04 Container/Closure Leachable Migration Evaluation testing and develop strategies for minimizing leachable migration risks.

    Conclusion

    In conclusion, Eurolabs expertise in JP 7.04 Container/Closure Leachable Migration Evaluation testing ensures that products meet regulatory requirements and minimize risks associated with leachable migration from container/closure systems. Our commitment to delivering high-quality testing services makes us the ideal partner for clients seeking to ensure product safety and reliability.

    References

    1. ISO 11607-1:2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems.

    2. ISO 10993-18:2020, Biological evaluation of medical devices - Part 18: Chemical characterization of materials.

    3. ASTM F1929-19: Standard Test Method for Leachable Extractables from Medical Devices (2019).

    4. EN ISO 11607-1:2018, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

    Appendix

    Eurolabs team of experts provides comprehensive JP 7.04 Container/Closure Leachable Migration Evaluation testing services. Our expertise ensures that products meet regulatory requirements and minimize risks associated with leachable migration from container/closure systems.

    Additional Information

    For more information about Eurolabs JP 7.04 Container/Closure Leachable Migration Evaluation testing services, please contact us at insert contact information.

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