EUROLAB
jp-602-aluminum-cap-material-leachables-testing
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 6.07 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 <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 6.02 Aluminum Cap Material Leachables Testing: A Comprehensive Guide to Eurolabs Laboratory Testing Services

Standard-Related Information

The JP 6.02 Aluminum Cap Material Leachables Testing is a laboratory testing service that evaluates the leachability of chemicals from aluminum caps used in pharmaceutical packaging. This testing is governed by various international and national standards, including:

  • ISO 10993-18:2017

  • ASTM F2313-17

  • EN 12216:2008

  • TSE 1151/2:2020

    • These standards specify the requirements for testing the leachability of chemicals from packaging materials, including aluminum caps. The EUROLAB laboratory testing service is designed to meet these standards and ensure that products are safe for use.

    Legal and Regulatory Framework

    The JP 6.02 Aluminum Cap Material Leachables Testing is regulated by various laws and regulations, including:

  • European Union (EU) Directive 2011/62/EU

  • EU Regulation (EC) No 1907/2006 (REACH)

  • FDA Guidance for Industry: Container Closure Systems for Packaging of Pharmaceutical Ingredients

    • These regulations require manufacturers to ensure that their products are safe for use and comply with specific standards. The JP 6.02 Aluminum Cap Material Leachables Testing service is designed to help manufacturers meet these regulatory requirements.

    Standard Development Organizations

    The development and maintenance of standards related to the JP 6.02 Aluminum Cap Material Leachables Testing service are overseen by 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 the safety and quality of products.

    Standard Evolution and Updates

    Standards related to the JP 6.02 Aluminum Cap Material Leachables Testing service are regularly updated to reflect new scientific research, technological advancements, and regulatory changes. Manufacturers must stay informed about updates to these standards to ensure compliance.

    Specific Standard Numbers and Their Scope

    The following standard numbers and their scope are relevant to the JP 6.02 Aluminum Cap Material Leachables Testing service:

  • ISO 10993-18:2017 - Biological evaluation of medical devices - Part 18: Chemical characterization of materials

  • ASTM F2313-17 - Standard Test Method for Determining the Release of Chemicals from Packaging Materials in Contact with Food and Beverages

  • EN 12216:2008 - Plastics packaging - Determination of the release of plasticizers from films

    • Standard Compliance Requirements

    Manufacturers must comply with specific standard requirements, including:

  • Testing of leachables from aluminum caps

  • Evaluation of chemical characterization of materials

  • Determination of the release of chemicals from packaging materials in contact with food and beverages

    • Failure to comply with these standards can result in regulatory fines, product recalls, and damage to a companys reputation.

    Standard Requirements and Needs

    The JP 6.02 Aluminum Cap Material Leachables Testing service is required for several reasons:

  • Business Reasons: Manufacturers must ensure that their products are safe for use and compliant with regulations.

  • Technical Reasons: The testing helps to evaluate the leachability of chemicals from aluminum caps, ensuring product safety.

    • Consequences of Not Performing This Test

    Failure to perform the JP 6.02 Aluminum Cap Material Leachables Testing service can result in:

  • Regulatory fines

  • Product recalls

  • Damage to a companys reputation

  • Loss of customer trust and confidence

    • Industries and Sectors that Require This Testing

    The following industries and sectors require the JP 6.02 Aluminum Cap Material Leachables Testing service:

  • Pharmaceuticals

  • Food and beverage packaging

  • Cosmetics and personal care products

  • Medical devices

    • Risk Factors and Safety Implications

    The JP 6.02 Aluminum Cap Material Leachables Testing service helps to mitigate risks associated with chemical leachability, including:

  • Toxicity of chemicals

  • Environmental impact

  • Product recalls and regulatory fines

    • Quality Assurance and Quality Control Aspects

    Eurolabs laboratory testing services adhere to strict quality assurance and control measures, including:

  • Calibration and validation procedures

  • Sampling and sample preparation procedures

  • Measurement and analysis methods

  • Data collection and recording procedures

    • Why This Test Should Be Performed

    The JP 6.02 Aluminum Cap Material Leachables Testing service provides several benefits, including:

  • Quality Assurance: Ensures product safety and compliance with regulations.

  • Risk Assessment: Helps to mitigate risks associated with chemical leachability.

  • Compliance Benefits: Ensures regulatory compliance and reduces the risk of fines and recalls.

    • Why Eurolab Should Provide This Service

    Eurolab is a leading laboratory testing service provider that offers expert analysis, state-of-the-art equipment, and certified personnel. Our team provides high-quality testing services, including:

  • Expert Analysis: Our experts have extensive knowledge in the field of chemical leachability.

  • State-of-the-Art Equipment: We use advanced analytical instruments to provide accurate results.

  • Certified Personnel: Our team members are certified to perform the JP 6.02 Aluminum Cap Material Leachables Testing service.

    • Conclusion

    The JP 6.02 Aluminum Cap Material Leachables Testing service is an essential tool for manufacturers to ensure product safety and compliance with regulations. Eurolabs laboratory testing services provide expert analysis, state-of-the-art equipment, and certified personnel to help manufacturers meet these regulatory requirements.

    By choosing Eurolab as your trusted laboratory testing partner, you can be confident that your products are safe for use and compliant with regulations. Contact us today to learn more about our JP 6.02 Aluminum Cap Material Leachables Testing service.

    Appendix

    Additional information on the JP 6.02 Aluminum Cap Material Leachables Testing service is available upon request. Please contact us at insert email address or insert phone number.

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers