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ep-2947-container-closure-system-integrity-testing-for-extractables
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 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 <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

EP 2.9.47 Container Closure System Integrity Testing for Extractables: A Comprehensive Guide to Laboratory Testing Services by Eurolab

Container Closure System Integrity Testing for Extractables, as defined in the EP 2.9.47 standard, is a critical laboratory testing service that ensures the quality and safety of pharmaceutical products. This article will provide an in-depth overview of the relevant standards governing this testing service, including ISO, ASTM, EN, TSE, and other international and national standards.

International Standards

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

  • ISO 11607-2:2019(E) - Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing, and testing sterile barrier systems in packaging systems

    • National Standards

  • ASTM F1980-12(2017) - Standard Practice for Extractable Testing of Medical Device Materials

  • EN 868-5:2013A1:2018 - Sterilization indicators -- Part 5: Biological evaluation

    • Standard Development Organizations (SDOs)

    The SDOs responsible for developing and maintaining the standards governing Container Closure System Integrity Testing for Extractables include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standard Evolution and Updates

    Standards are regularly reviewed and updated to reflect the latest scientific research, technological advancements, and regulatory requirements. This ensures that laboratory testing services like EP 2.9.47 remain relevant and effective.

    Specific Standard Numbers and Scope

    The following standard numbers and scopes apply to Container Closure System Integrity Testing for Extractables:

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

  • ASTM F1980-12(2017) - Standard Practice for Extractable Testing of Medical Device Materials

    • Standard Compliance Requirements

    Compliance with these standards is mandatory for pharmaceutical companies, medical device manufacturers, and contract testing laboratories. Failure to comply can result in product recalls, regulatory fines, or even business closure.

    Container Closure System Integrity Testing for Extractables is a critical laboratory test that ensures the quality and safety of pharmaceutical products. This section will explain why this specific test is needed and required, including the business and technical reasons for conducting EP 2.9.47 testing.

    Business and Technical Reasons

    The primary reason for conducting Container Closure System Integrity Testing for Extractables is to ensure the safety and efficacy of pharmaceutical products. Leaks or defects in container closure systems can compromise product sterility, purity, and potency, leading to patient harm or even death. Compliance with regulatory requirements and industry standards is essential to avoid recalls, fines, and damage to reputation.

    Consequences of Not Performing This Test

    Failure to conduct Container Closure System Integrity Testing for Extractables can result in:

  • Product contamination and recalls

  • Regulatory fines and penalties

  • Damage to company reputation and brand image

  • Patient harm or even death

    • Industries and Sectors Requiring This Testing

    Pharmaceutical companies, medical device manufacturers, and contract testing laboratories are among the industries that require Container Closure System Integrity Testing for Extractables.

    Risk Factors and Safety Implications

    The risk factors associated with container closure system defects include:

  • Product contamination

  • Sterility breaches

  • Purity compromises

  • Potency degradation

    • Quality Assurance and Quality Control Aspects

    Container Closure System Integrity Testing for Extractables is an essential component of quality assurance and quality control (QA/QC) programs. This test ensures that products meet regulatory requirements, industry standards, and customer expectations.

    This section will provide a detailed explanation of the testing conditions, methodology, and equipment used for Container Closure System Integrity Testing for Extractables.

    Testing Equipment and Instruments

    The following equipment and instruments are used for this test:

  • Sterile barrier system (SBS) tester

  • Package integrity tester

  • Microbiological analyzer

    • Testing Environment Requirements

    The testing environment requires a controlled atmosphere, including temperature, humidity, and pressure. The specific requirements for these parameters will be explained in detail.

    Sample Preparation Procedures

    Samples are prepared according to the specific standard or regulatory requirement, which may include sterilization, packaging, or other procedures.

    Testing Parameters and Conditions

    The testing parameters and conditions for Container Closure System Integrity Testing for Extractables include:

  • Temperature

  • Humidity

  • Pressure

  • Package integrity

    • Measurement and Analysis Methods

    The measurement and analysis methods used for this test include:

  • Visual inspection

  • Physical testing (e.g., burst testing)

  • Microbiological testing

    • Test Conditions and Methodology

    The specific test conditions and methodology will be explained in detail, including the equipment, materials, and procedures used.

    Standard Compliance Requirements

    Compliance with regulatory requirements and industry standards is essential for Container Closure System Integrity Testing for Extractables. Failure to comply can result in product recalls, fines, or even business closure.

    Persuasive Writing (insert persuasive writing here)

    In conclusion, Container Closure System Integrity Testing for Extractables is a critical laboratory test that ensures the quality and safety of pharmaceutical products. Compliance with regulatory requirements and industry standards is essential to avoid recalls, fines, and damage to reputation. Eurolabs expert team provides comprehensive testing services for Container Closure System Integrity Testing for Extractables, ensuring your company meets regulatory requirements and maintains a strong reputation.

    Professional Tone

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    Commercial Appeal

    The text should appeal to the readers commercial interests, highlighting the benefits of compliance with regulatory requirements and industry standards. Emphasize the importance of Container Closure System Integrity Testing for Extractables in maintaining a strong reputation and avoiding costly recalls and fines.

    Highly Informative

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    Accurate Technical Information

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