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fda-guidance-container-closure-systems-for-drug-products-el-focus
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: 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

Comprehensive Guide to FDA Guidance: Container Closure Systems for Drug Products EL Focus Laboratory Testing Services

Standard-Related Information

The FDA Guidance on Container Closure Systems for Drug Products - EL Focus laboratory testing is governed by a set of international and national standards that ensure the safety and quality of drug products. These standards are developed and maintained by standard development organizations (SDOs) such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), Turkish Standards Institution (TSE), and others.

International Standards

  • ISO 9001:2015 - Quality Management Systems

  • ISO 13485:2016 - Medical Devices - Quality Management Systems

  • ASTM E1300-17 - Standard Practice for Risk-Based Sampling for Elements in Materials by Energy-Dispersive X-ray Fluorescence Spectroscopy

  • EN 12095:2003A1:2009 - Surgical suture materials and suture needles - Particular requirements

    • National Standards

  • USP <661> - Container Closure Systems for Packaging of Inhalation Aerosol Products

  • FDA Guidance on Container Closure Systems for Drug Products - EL Focus laboratory testing (21 CFR 211.110)

    • Standard Development Organizations

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulatory requirements, and industry best practices. SDOs continuously update standards through a rigorous process that involves stakeholder engagement, expert review, and public comment.

    Standard Numbers and Scope

  • ISO 9001:2015 - Quality Management Systems (general standard)

  • ISO 13485:2016 - Medical Devices - Quality Management Systems (specific to medical devices)

  • ASTM E1300-17 - Standard Practice for Risk-Based Sampling for Elements in Materials by Energy-Dispersive X-ray Fluorescence Spectroscopy (specific to materials testing)

  • EN 12095:2003A1:2009 - Surgical suture materials and suture needles - Particular requirements (specific to surgical suture materials)

    • Standard Compliance Requirements

    Compliance with standards is a critical aspect of ensuring product safety and quality. Companies must ensure that their products, processes, and systems meet the requirements specified in relevant standards.

    Standard-Related Information Conclusion

    Understanding the relevant standards, standard development organizations, and the evolution of standards is essential for companies to ensure compliance and maintain product safety and quality.

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    Standard Requirements and Needs

    The FDA Guidance on Container Closure Systems for Drug Products - EL Focus laboratory testing is a critical aspect of ensuring the safety and quality of drug products. This test is required by regulatory authorities, such as the US FDA, to ensure that container closure systems meet specific requirements.

    Why this Specific Test is Needed and Required

    The EL Focus test is needed and required due to several reasons:

  • Ensures the safety and quality of drug products

  • Meets regulatory requirements

  • Reduces product recalls and liability risks

  • Enhances customer confidence and trust

  • Improves competitiveness and market positioning

    • Business and Technical Reasons for Conducting this Test

    Conducting the EL Focus test provides several business and technical benefits:

  • Ensures compliance with regulatory requirements

  • Reduces product recalls and liability risks

  • Enhances customer confidence and trust

  • Improves competitiveness and market positioning

  • Supports innovation and research development

    • Consequences of Not Performing this Test

    Failure to perform the EL Focus test can lead to several consequences, including:

  • Non-compliance with regulatory requirements

  • Increased product recalls and liability risks

  • Reduced customer confidence and trust

  • Decreased competitiveness and market positioning

  • Regulatory fines and penalties

    • ---

    Test Conditions and Methodology

    The EL Focus test is conducted using a specific set of testing conditions and methodology.

    Step-by-Step Explanation of the Test

    1. Sample preparation: Samples are prepared according to standard procedures.

    2. Testing equipment and instruments: The test is performed using specialized testing equipment and instruments, such as X-ray fluorescence (XRF) spectrometers.

    3. Testing environment requirements: The test is conducted in a controlled environment with specific temperature, humidity, and pressure conditions.

    4. Sample preparation procedures: Samples are prepared according to standard procedures.

    5. Testing parameters and conditions: The test is performed under specific testing parameters and conditions.

    6. Measurement and analysis methods: Test results are measured and analyzed using specialized software and equipment.

    Testing Equipment and Instruments

    The EL Focus test is conducted using the following testing equipment and instruments:

  • X-ray fluorescence (XRF) spectrometers

  • Inductively coupled plasma mass spectrometry (ICP-MS)

  • Atomic absorption spectroscopy (AAS)

    • Testing Environment Requirements

    The EL Focus test is conducted in a controlled environment with specific temperature, humidity, and pressure conditions.

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    Test Conditions and Methodology Conclusion

    Understanding the testing conditions and methodology of the EL Focus test is essential for companies to ensure compliance and maintain product safety and quality.

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    Conclusion

    In conclusion, the FDA Guidance on Container Closure Systems for Drug Products - EL Focus laboratory testing is a critical aspect of ensuring the safety and quality of drug products. Companies must understand the relevant standards, standard development organizations, and the evolution of standards to ensure compliance and maintain product safety and quality.

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