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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 DevicesEP 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 <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 EMA Guideline on Plastic Immediate Packaging Materials - EL Laboratory Testing Service Provided by Eurolab

The European Medicines Agency (EMA) has established guidelines for the evaluation of immediate packaging materials used in pharmaceutical products. The EMA Guideline on Plastic Immediate Packaging Materials EL testing is a critical aspect of ensuring the safety and quality of these materials.

International and National Standards

Several international standards govern the testing of plastic immediate packaging materials, including:

  • ISO 10993-12:2012 (Biological evaluation of medical devices - Part 12: Sample preparation and reference materials)

  • ASTM F1980-11 (Standard Practice for Testing Plastic Immediate Packaging Materials for Pharmaceutical Applications)

  • EN 14638-1:2006 (Medical gloves for single use - Part 1: Requirements and testing)

    • National standards, such as TSE (Turkish Standards Institution) and CEN (European Committee for Standardization), also play a crucial role in ensuring compliance with regulatory requirements.

    Standard Development Organizations

    The International Organization for Standardization (ISO) is the primary standard development organization responsible for creating and maintaining international standards. Other organizations, like ASTM and EN, contribute to the development of national and regional standards.

    Evolution of Standards

    Standards evolve over time as new technologies emerge and scientific understanding advances. Regular updates ensure that testing methodologies remain relevant and effective in detecting potential hazards.

    Specific Standard Numbers and Scope

    Some key standard numbers and their scope include:

  • ISO 10993-12:2012: Evaluates the chemical compatibility of plastic materials with pharmaceutical products

  • ASTM F1980-11: Assesses the suitability of plastic packaging materials for pharmaceutical applications

    • Standard Compliance Requirements

    Compliance with these standards is mandatory in various industries, including:

  • Pharmaceutical manufacturing

  • Medical device production

  • Cosmetics and personal care product development

    • Failure to comply can result in regulatory penalties, product recalls, and damage to reputation.

    In addition to the standards mentioned earlier, other relevant guidelines include:

  • EMA Guideline on Plastic Immediate Packaging Materials EL testing

  • FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs

    • These documents provide essential information on the evaluation and testing of plastic packaging materials.

    Why is this test needed?

    The EMA Guideline on Plastic Immediate Packaging Materials EL testing is necessary to ensure that pharmaceutical products are packaged in safe, high-quality materials. This includes evaluating the chemical compatibility of plastics with medications and assessing potential leachables.

    Business and Technical Reasons for Conducting EMA Guideline on Plastic Immediate Packaging Materials EL Testing

    Conducting this test provides several benefits:

  • Ensures product safety and quality

  • Supports regulatory compliance

  • Enhances customer trust and confidence

  • Facilitates international trade

    • Consequences of Not Performing the Test

    Failure to conduct this test can result in:

  • Regulatory penalties and fines

  • Product recalls and market withdrawal

  • Damage to reputation and brand image

  • Loss of business and revenue

    • Industries and Sectors Requiring EMA Guideline on Plastic Immediate Packaging Materials EL Testing

    The following industries require compliance with the EMA Guideline on Plastic Immediate Packaging Materials EL testing:

  • Pharmaceutical manufacturing

  • Medical device production

  • Cosmetics and personal care product development

    • Risk Factors and Safety Implications

    Non-compliance with regulatory requirements can lead to significant risks, including:

  • Exposure to hazardous chemicals

  • Contamination of products

  • Damage to equipment and facilities

    • Quality Assurance and Quality Control Aspects

    To ensure compliance, manufacturers must establish robust quality assurance and control systems. This includes regular testing and evaluation of plastic packaging materials.

    Contribution to Product Safety and Reliability

    The EMA Guideline on Plastic Immediate Packaging Materials EL testing contributes significantly to product safety and reliability by:

  • Evaluating chemical compatibility

  • Assessing potential leachables

    • Competitive Advantages and Market Positioning

    By conducting this test, manufacturers can differentiate themselves from competitors, enhance their market positioning, and build customer trust.

    Cost-Benefit Analysis of Performing the Test

    Conducting the EMA Guideline on Plastic Immediate Packaging Materials EL testing provides a cost-benefit analysis:

  • Reduces regulatory risks

  • Enhances product safety and quality

  • Supports compliance with international standards

    • Step-by-Step Explanation of Testing

    The EMA Guideline on Plastic Immediate Packaging Materials EL testing involves the following steps:

    1. Sample preparation

    2. Chemical analysis

    3. Evaluation of potential leachables

    Testing Equipment and Instruments Used

    The following equipment is used for this test:

  • Gas chromatography (GC) or liquid chromatography (LC)

  • Mass spectrometry (MS)

    • Evaluation Criteria

    The evaluation criteria include assessing the chemical compatibility of plastic materials with pharmaceutical products, identifying potential leachables, and evaluating their impact on product safety.

    Methodology Overview

    The testing methodology involves:

    1. Sample preparation: Collecting and preparing the plastic packaging material samples

    2. Chemical analysis: Analyzing the samples using GC or LC-MS techniques

    3. Evaluation of potential leachables: Identifying and assessing the chemical compatibility of plastics with pharmaceutical products

    The following factors are considered during testing:

  • Material composition

  • Temperature and humidity conditions

  • Time exposure to chemicals

    • Data Analysis

    The data analysis involves evaluating the test results, identifying potential leachables, and assessing their impact on product safety.

    Interpretation of Results

    The interpretation of results includes:

  • Evaluating chemical compatibility

  • Identifying potential leachables

    • Test Report

    A comprehensive test report is generated, including:

  • Test methodology

  • Data analysis

  • Interpretation of results

    • This document provides a detailed overview of the EMA Guideline on Plastic Immediate Packaging Materials EL testing and its importance in ensuring product safety and quality.

    Conclusion

    The EMA Guideline on Plastic Immediate Packaging Materials EL testing is a critical aspect of pharmaceutical product development. By following these guidelines, manufacturers can ensure compliance with regulatory requirements, enhance product safety and quality, and build customer trust.

    By understanding the standards, requirements, and methodology involved in this test, manufacturers can navigate the complex world of regulatory compliance with confidence.

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