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jp-607-plastic-containers-for-aqueous-injections-leachable-standards
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 6.10 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

JP 6.07 Plastic Containers for Aqueous Injections Leachable Standards Laboratory Testing Service

A Comprehensive Guide to Ensuring Product Safety and Regulatory Compliance

JP 6.07 Plastic Containers for Aqueous Injections Leachable Standards testing is governed by a range of international and national standards, ensuring the safety and quality of plastic containers used in pharmaceutical applications. This section provides an overview of the relevant standards, their development, and application.

ISO Standards

  • ISO 10993-18:2017 specifies the requirements for the selection of plastic materials for medical devices, including aqueous injections.

  • ISO 11607-1:2006A1:2015 describes the packaging requirements for sterile medical devices, including injectable solutions.

    • ASTM Standards

  • ASTM F1980-08 (2013) sets forth requirements for polymeric components and systems used in implantable medical devices.

  • ASTM F739-03 (2013) provides a method for evaluating the leachables from plastic materials intended for use in parenteral drug products.

    • EN Standards

  • EN 1662:2009A1:2015 specifies the requirements for packaging materials for sterile and non-sterile pharmaceuticals, including injectable solutions.

  • EN ISO 10993-18:2017A1:2020 describes the selection of plastic materials for medical devices.

    • TSE Standards

  • TSE ISO 10993-18:2018 specifies the requirements for the selection of plastic materials for medical devices.

  • TSE EN 1662:2009A1:2015 describes the packaging requirements for sterile and non-sterile pharmaceuticals.

    • Standard Development Organizations

    The International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), and Turkish Standards Institution (TSE) are the primary standard development organizations involved in JP 6.07 Plastic Containers for Aqueous Injections Leachable Standards testing.

    Standard Evolution and Updates

    Standards evolve through a collaborative effort between industry stakeholders, regulatory bodies, and technical experts. Regular updates ensure that standards remain relevant to emerging technologies and changing regulatory requirements.

    Specific Standard Numbers and Scope

  • ISO 10993-18:2017A1:2020 specifies the requirements for plastic materials used in medical devices.

  • ASTM F1980-08 (2013) sets forth requirements for polymeric components and systems used in implantable medical devices.

    • Standard Compliance Requirements

    Compliance with these standards is mandatory for manufacturers of pharmaceutical products, including those using plastic containers for aqueous injections. Non-compliance can result in product recalls, regulatory fines, or even market withdrawal.

    Standard-Related Risks and Implications

    Failure to comply with JP 6.07 Plastic Containers for Aqueous Injections Leachable Standards testing can lead to patient harm, product contamination, and reputational damage. Regulatory agencies enforce compliance through regular audits and inspections.

    Business and Technical Reasons for Conducting Testing

    Conducting JP 6.07 Plastic Containers for Aqueous Injections Leachable Standards testing is essential for ensuring product safety, quality, and regulatory compliance. This test provides manufacturers with the necessary data to support claims of leachables-free products.

    Consequences of Not Performing Testing

    Failure to perform this test can lead to costly product recalls, reputational damage, and even legal action against manufacturers. Regulatory agencies enforce compliance through regular audits and inspections.

    Industries and Sectors Requiring Testing

    Pharmaceutical manufacturers, medical device companies, and packaging material suppliers require JP 6.07 Plastic Containers for Aqueous Injections Leachable Standards testing to ensure product safety and regulatory compliance.

    Risk Factors and Safety Implications

    Leachables from plastic containers can contaminate injectable solutions, posing risks to patient health and product efficacy. Manufacturers must ensure that their products meet the required standards to avoid reputational damage and financial losses.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality management system ensures accurate and reliable test results, meeting or exceeding industry standards. Our laboratory is accredited by international accreditation bodies, guaranteeing the integrity of our testing services.

    JP 6.07 Plastic Containers for Aqueous Injections Leachable Standards testing involves a range of methods to evaluate leachables from plastic containers. This section provides an overview of the test conditions, methodology, and equipment used.

    Testing Equipment and Instruments

    Eurolab uses state-of-the-art equipment, including gas chromatography-mass spectrometry (GC-MS), liquid chromatography-tandem mass spectrometry (LC-MS/MS), and high-performance liquid chromatography (HPLC).

    Sample Preparation

    Samples are prepared according to the relevant standard, ensuring accurate and reliable test results.

    Testing Conditions

    Test conditions include temperature, pressure, and exposure time, simulating real-world scenarios for aqueous injections.

    Data Analysis and Interpretation

    Eurolabs expert analysts interpret test data, providing manufacturers with actionable insights to support their products claims of leachables-free.

    Test Report and Certificate

    Eurolab issues a comprehensive test report and certificate, detailing the results and ensuring compliance with regulatory requirements.

    Standard-Related Regulations and Requirements

    Regulatory agencies enforce JP 6.07 Plastic Containers for Aqueous Injections Leachable Standards testing through regular audits and inspections.

    Product Safety and Regulatory Compliance

    Conducting JP 6.07 Plastic Containers for Aqueous Injections Leachable Standards testing ensures product safety, regulatory compliance, and market acceptance.

    Test Report and Certificate

    Eurolab issues a comprehensive test report and certificate, detailing the results and ensuring compliance with regulatory requirements.

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