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ep-322-plastic-containers-and-closures-for-pharmaceutical-use
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 3.2.8 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

EUROLABs Comprehensive Guide to EP 3.2.2 Plastic Containers and Closures for Pharmaceutical Use Laboratory Testing Service

As a leading laboratory testing service provider, Eurolab is committed to delivering high-quality testing solutions that meet the stringent requirements of various industries, including pharmaceuticals. In this article, we will delve into the intricacies of EP 3.2.2 Plastic Containers and Closures for Pharmaceutical Use testing, exploring its significance, methodologies, and benefits.

EP 3.2.2 is a standard that governs the testing of plastic containers and closures used in pharmaceutical packaging. This standard is part of the European Pharmacopoeia (Ph. Eur.), which sets out the requirements for pharmaceutical substances, excipients, and packaging materials.

The European Pharmacopoeia Commission, responsible for developing and updating Ph. Eur., ensures that standards are aligned with international regulations and harmonized with other regional pharmacopeias. EP 3.2.2 is based on various international standards, including ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), EN (European Standard), TSE (Turkish Standards Institution), and others.

Legal and Regulatory Framework

The use of plastic containers and closures in pharmaceutical packaging is subject to regulatory requirements set forth by national authorities, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Compliance with these regulations is mandatory for companies operating in the pharmaceutical industry.

In Europe, the European Unions Good Manufacturing Practice (GMP) regulations (EU GMP) govern the manufacture of medicinal products, including packaging materials. The regulations specify the requirements for quality control, documentation, and validation of manufacturing processes.

International and National Standards

The following standards are relevant to EP 3.2.2:

  • ISO 11607:2016 - Packaging for terminally sterilized medical devices

  • ASTM F2103-13 - Performance of materials used in the construction of portable gas cylinders for breathing under compressed oxygen

  • EN 1351-1:2017 - Gas detectors and alarm devices for flammable gases. Requirements for safety and performance

  • TSE ISO/IEC 17025:2006 - General requirements for the competence of testing and calibration laboratories

    • These standards outline specific requirements for packaging materials, including plastic containers and closures.

    Standard Development Organizations

    The following organizations contribute to the development and maintenance of standards related to EP 3.2.2:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Standardization Committee (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations work together to ensure that international and national standards are harmonized.

    Standard Evolution and Updates

    Standards evolve over time as new technologies, materials, or requirements emerge. Standard development organizations engage in continuous review and revision of existing standards to ensure they remain relevant and effective.

    Eurolab stays up-to-date with the latest developments by regularly reviewing and updating its testing procedures to align with the revised standards.

    Standard Numbers and Scope

    The following are specific standard numbers related to EP 3.2.2:

  • ISO 11607:2016 - Packaging for terminally sterilized medical devices

  • ASTM F2103-13 - Performance of materials used in the construction of portable gas cylinders for breathing under compressed oxygen

    • Each standard has a distinct scope, and Eurolab ensures that its testing services comply with these standards.

    Standard Compliance Requirements

    Companies operating in the pharmaceutical industry must demonstrate compliance with relevant standards. Eurolabs EP 3.2.2 testing service helps ensure compliance by verifying that plastic containers and closures meet the required specifications.

    Why is this specific test needed and required?

    Pharmaceutical packaging materials must be designed to prevent contamination, leakage, or other issues that could compromise product safety. EP 3.2.2 testing ensures that plastic containers and closures meet the required standards for pharmaceutical use.

    Business and Technical Reasons

    The primary reason for conducting EP 3.2.2 testing is to ensure compliance with regulatory requirements. Companies must demonstrate that their packaging materials meet the necessary specifications to maintain market access and avoid product recalls.

    From a technical perspective, EP 3.2.2 testing assesses the performance of plastic containers and closures under various conditions, including temperature, humidity, and pressure.

    Consequences of Not Performing this Test

    Failure to perform EP 3.2.2 testing can result in:

  • Product recalls

  • Loss of market access

  • Reduced customer confidence

  • Increased costs due to regulatory non-compliance

    • Industries and Sectors that Require this Testing

    Pharmaceutical companies, medical device manufacturers, and packaging material suppliers require EP 3.2.2 testing for their products.

    Benefits of Conducting EP 3.2.2 Testing

    Eurolabs EP 3.2.2 testing service offers several benefits:

  • Compliance with regulatory requirements

  • Reduced risk of product recalls or market access issues

  • Improved customer confidence and brand reputation

  • Cost savings due to reduced need for re-testing or rectification measures

    • Eurolabs EP 3.2.2 testing service involves a series of steps:

    1. Sample Preparation: Eurolab receives samples of plastic containers and closures from clients.

    2. Testing Equipment Calibration: Testing equipment is calibrated to ensure accuracy and precision.

    3. Test Procedures: Testing procedures are carried out in accordance with the relevant standards, including ISO 11607:2016 and ASTM F2103-13.

    4. Data Analysis: Test results are analyzed and compared against the required specifications.

    Eurolabs testing services include:

  • Dimensional analysis

  • Material characterization (e.g., tensile strength, impact resistance)

  • Performance testing under various conditions (e.g., temperature, humidity, pressure)

    • Test Results and Reporting

    Test results are presented in a clear and concise manner, including:

  • Pass/fail status for each test

  • Detailed description of the testing methodology used

  • Graphs or charts illustrating the test results

  • Recommendations for any necessary corrective actions

    • Eurolabs reports comply with international standards for laboratory reporting.

    Quality Management

    Eurolab maintains a quality management system (QMS) that adheres to the principles of ISO 9001:2015. The QMS ensures:

  • Continuous improvement in testing services

  • Compliance with relevant regulatory requirements

  • Effective communication with clients and stakeholders

    • CONCLUSION

    In conclusion, Eurolabs EP 3.2.2 testing service is an essential tool for companies operating in the pharmaceutical industry. By ensuring compliance with regulatory requirements, reducing risk of product recalls or market access issues, and improving customer confidence, Eurolab helps companies maintain a strong brand reputation.

    By understanding the intricacies of EP 3.2.2 testing, companies can ensure that their plastic containers and closures meet the required standards for pharmaceutical use.

    FINAL REMARKS

    Eurolabs commitment to delivering high-quality testing services ensures compliance with regulatory requirements and reduces risk for clients operating in the pharmaceutical industry.

    For more information on Eurolabs EP 3.2.2 testing service, please contact us at infoeurolab.com(mailto:infoeurolab.com) or visit our website at eurolab.com.

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