EUROLAB
usp-1207-container-closure-integrity-and-leachable-entry
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 <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

USP <1207> Container Closure Integrity and Leachable Entry Laboratory Testing Service: A Comprehensive Guide

As the pharmaceutical industry continues to evolve, ensuring the safety and efficacy of products is of utmost importance. One critical aspect of product development is testing for container closure integrity (CCI) and leachable entry. In this article, we will delve into the world of USP <1207> Container Closure Integrity and Leachable Entry laboratory testing services provided by Eurolab.

Standard-Related Information

The United States Pharmacopeia (USP) publishes standards for pharmaceutical products, including guidelines for container closure integrity and leachable entry. USP <1207> is a specific standard that outlines the requirements for CCI and leachable entry testing.

International and National Standards

Several international and national standards govern USP <1207> Container Closure Integrity and Leachable Entry testing:

  • ISO 11607-1:2019 (Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for materials, sterile barrier systems, and packaging systems)

  • ASTM F2090-13 (Standard Test Method for Testing the Performance of a Closure System for Pharmaceutical Applications)

  • EN 1661:2006 (Thermoplastic films for pharmaceutical applications)

  • TSE (Turkish Standards Institution) 16542:2014 (Pharmaceutical packaging materials)

  • USP <1207> Container Closure Integrity and Leachable Entry

    • Standard Development Organizations

    Standard development organizations, such as the International Organization for Standardization (ISO), ASTM, and the European Committee for Standardization (CEN), play a crucial role in creating and updating standards.

    Evolution of Standards

    Standards are constantly evolving to reflect changes in technology, regulations, and industry practices. Eurolab stays up-to-date with the latest developments to ensure that our testing services meet the most stringent requirements.

    Standard Numbers and Scope

    Some relevant standard numbers and their scope include:

  • ISO 11607-1:2019 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for materials, sterile barrier systems, and packaging systems

  • ASTM F2090-13 Standard Test Method for Testing the Performance of a Closure System for Pharmaceutical Applications

    • Standard Compliance Requirements

    Compliance with these standards is mandatory in various industries:

  • Pharmaceutical companies must adhere to USP <1207> Container Closure Integrity and Leachable Entry testing requirements.

  • Medical device manufacturers must comply with ISO 11607-1:2019.

  • Food packaging companies may need to follow ASTM F2090-13.

    • Standard Requirements and Needs

    The CCI and leachable entry tests are essential for ensuring product safety, efficacy, and regulatory compliance. These tests help:

    1. Ensure Product Safety: By testing the integrity of containers and leachables, manufacturers can prevent contamination and ensure that products meet quality standards.

    2. Meet Regulatory Requirements: Compliance with USP <1207> Container Closure Integrity and Leachable Entry requirements is necessary for regulatory approval in various industries.

    3. Prevent Liability: Failure to conduct these tests can result in costly recalls, product damage, or even lawsuits.

    Risk Factors and Safety Implications

    CCI and leachable entry testing helps mitigate risks associated with:

    1. Contamination: Leachables from packaging materials can contaminate products, compromising their quality and safety.

    2. Product Damage: CCI failures can lead to product damage, affecting shelf life and performance.

    Quality Assurance and Quality Control

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

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

    2. Sample Preparation Procedures: We follow strict sample preparation procedures to minimize errors and contamination risks.

    Test Conditions and Methodology

    The CCI and leachable entry tests involve several steps:

    1. Equipment and Instruments: Specialized testing equipment, such as helium leak detectors and GC/MS instruments, are used for these tests.

    2. Testing Environment Requirements: Temperature, humidity, pressure, and other environmental factors are carefully controlled during testing.

    3. Sample Preparation Procedures: Samples are prepared according to established procedures to ensure accuracy.

    Test Reporting and Documentation

    Results are thoroughly documented and reported:

    1. Report Format and Structure: Reports follow a standardized format, including test results, conclusions, and recommendations.

    2. Certification and Accreditation: Eurolabs certifications and accreditations are included in reports to demonstrate compliance with industry standards.

    Why This Test Should Be Performed

    Performing the CCI and leachable entry tests offers numerous benefits:

    1. Risk Assessment and Mitigation: These tests help identify potential risks and prevent contamination, product damage, or regulatory issues.

    2. Quality Assurance and Compliance: Regular testing ensures compliance with industry standards and regulations, reducing the risk of costly recalls or product damage.

    Conclusion

    USP <1207> Container Closure Integrity and Leachable Entry laboratory testing services provided by Eurolab ensure that products meet the highest quality and safety standards. By staying up-to-date with the latest developments in standardization, we provide accurate and reliable results to help manufacturers comply with industry regulations and mitigate risks associated with CCI and leachable entry.

    About Eurolab

    Eurolab is a leading provider of laboratory testing services for pharmaceuticals, medical devices, and food packaging. Our team of experts ensures that our testing services meet the most stringent requirements, providing accurate and reliable results to help manufacturers comply with industry regulations and mitigate risks associated with CCI and leachable entry.

    Contact Us

    For more information about Eurolabs USP <1207> Container Closure Integrity and Leachable Entry laboratory testing services or to schedule a consultation, please visit our website at www.eurolab.com(http://www.eurolab.com) or contact us directly at 1 (800) 123-4567.

    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