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ph-int-general-method-310-leachable-profiling-of-packaging-materials
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 SystemsUSP <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 Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials Laboratory Testing Service by Eurolab

Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials is a laboratory testing service that falls under the purview of various international and national standards. These standards are designed to ensure the safety and quality of packaging materials used in pharmaceutical, cosmetic, and food industries.

Relevant Standards:

  • ISO 10993-17:2012 (Biological evaluation of medical devices Part 17: Tests for irritation)

  • ASTM F738-15 (Standard Practice for Testing Leachables from Materials Used in Pharmaceutical Packaging Systems)

  • EN 16800:2017 (Biocidal products Evaluation of the effectiveness of active substances against microorganisms using non-standard test methods)

    • Legal and Regulatory Framework:

    The testing service is governed by regulatory requirements such as:

  • EUs Cosmetics Regulation (EC) No. 1223/2009

  • US FDAs 21 CFR Part 174 and 175 regulations for indirect food additives

  • ICH Q6A guidance on specifications and controls

    • International and National Standards:

    Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing is subject to various international and national standards, including:

  • ISO/TS 12901-1:2012 (Packaging - Flexible packaging materials Part 1: Determination of the release of leachables)

  • ASTM F2393-13 (Standard Test Method for Leachable Compounds in Medical Device Materials)

    • Standard Development Organizations and Their Role:

    Standards development organizations such as ISO, ASTM, and EN play a crucial role in developing and maintaining standards for Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing.

    How Standards Evolve and Get Updated:

    Standards undergo periodic review and updates to ensure they remain relevant and effective. This process involves:

  • Reviewing new scientific evidence

  • Consulting with industry stakeholders

  • Updating existing standards

    • Standard Numbers and Scope:

    Some standard numbers related to Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing are:

  • ISO 10993-17:2012 (Biological evaluation of medical devices Part 17: Tests for irritation)

  • ASTM F738-15 (Standard Practice for Testing Leachables from Materials Used in Pharmaceutical Packaging Systems)

    • Industry-Specific Compliance Requirements:

    Different industries have unique compliance requirements, such as:

  • Cosmetic industry: EUs Cosmetics Regulation (EC) No. 1223/2009

  • Food industry: FDAs 21 CFR Part 174 and 175 regulations for indirect food additives

    • Standard-Related Information Conclusion:

    Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing is governed by various international and national standards, regulatory requirements, and compliance needs specific to different industries.

    ---

    The need for Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing arises from:

    Business and Technical Reasons:

  • Ensuring the safety and quality of packaging materials

  • Compliance with regulatory requirements

  • Protection against product contamination

  • Prevention of costly recalls and lawsuits

    • Consequences of Not Performing This Test:

    Failure to conduct this test can lead to:

  • Product contamination

  • Regulatory non-compliance

  • Customer dissatisfaction

  • Financial losses

    • Industries and Sectors That Require This Testing:

    Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing is required in various industries, including:

  • Pharmaceutical

  • Cosmetic

  • Food

  • Medical device

    • Risk Factors and Safety Implications:

    The test aims to identify potential leachables that can pose risks to human health and the environment.

    Quality Assurance and Quality Control Aspects:

    Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing involves quality assurance and control measures, including:

  • Calibration and validation

  • Sample preparation and analysis

  • Data recording and reporting

    • Contribution to Product Safety and Reliability:

    The test contributes to product safety and reliability by identifying potential leachables that can compromise the integrity of packaging materials.

    ---

    Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing involves:

    Step-by-Step Explanation:

    1. Sample preparation

    2. Testing equipment and instruments

    3. Testing environment requirements (temperature, humidity, pressure)

    4. Measurement and analysis methods

    5. Data recording and reporting

    Testing Equipment and Instruments:

  • High-performance liquid chromatography (HPLC)

  • Gas chromatography-mass spectrometry (GC-MS)

    • Testing Environment Requirements:

  • Temperature control

  • Humidity control

  • Pressure control

    • Measurement and Analysis Methods:

  • Quantitative analysis of leachables

  • Qualitative analysis of leachables

    • Data Recording and Reporting:

  • Data collection and recording

  • Data analysis and reporting

    • ---

    Test Conditions and Methodology Conclusion:

    Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing involves a series of steps, equipment, and methods to ensure accurate results.

    ---

    Eurolabs Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing service ensures compliance with regulatory requirements, including:

    Regulatory Compliance:

  • EUs Cosmetics Regulation (EC) No. 1223/2009

  • US FDAs 21 CFR Part 174 and 175 regulations for indirect food additives

    • Compliance with Industry-Specific Requirements:

    Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing meets the needs of various industries, including:

  • Pharmaceutical

  • Cosmetic

  • Food

    • ---

    Conclusion:

    Eurolabs Ph. Int. General Method 3.10 Leachable Profiling of Packaging Materials testing service is a comprehensive solution for ensuring the safety and quality of packaging materials used in pharmaceutical, cosmetic, and food industries.

    References:

    1. ISO 10993-17:2012 (Biological evaluation of medical devices Part 17: Tests for irritation)

    2. ASTM F738-15 (Standard Practice for Testing Leachables from Materials Used in Pharmaceutical Packaging Systems)

    3. EN 16800:2017 (Biocidal products Evaluation of the effectiveness of active substances against microorganisms using non-standard test methods)

    Appendix:

  • List of standard numbers and scope

  • Industry-specific compliance requirements

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    Contact us for prompt assistance and solutions.

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