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astm-d7823-screening-of-phthalates-in-plastic-components
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 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 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

ASTM D7823 Screening of Phthalates in Plastic Components Laboratory Testing Service: A Comprehensive Guide

The ASTM D7823 Screening of Phthalates in Plastic Components testing service is a critical laboratory test that ensures the safety and compliance of plastic components with regulatory standards. This section provides an in-depth overview of the relevant standards, legal framework, and standard development organizations.

Relevant Standards:

  • ASTM D7823-18: Standard Test Method for Determination of Phthalates in Plastic Components by Gas Chromatography/Mass Spectrometry (GC/MS)

  • ISO 18286:2015: Plastics - Determination of phthalate esters in plastic materials

  • EN 14338:2016: Plastics - Determination of phthalate esters in plastic materials

  • TSE 1421:2017: Plastics - Determination of phthalate esters in plastic materials

    • Legal and Regulatory Framework:

    The ASTM D7823 testing service is governed by various regulatory bodies, including:

  • European Unions (EU) Restriction of Hazardous Substances (RoHS) Directive

  • EUs Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation

  • US Environmental Protection Agencys (EPA) Toxic Substances Control Act (TSCA)

  • US Consumer Product Safety Commissions (CPSC) regulations

    • Standard Development Organizations:

    The following organizations play a crucial role in developing and maintaining standards related to ASTM D7823:

  • American Society for Testing and Materials (ASTM)

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (CEN)

    • Evolution of Standards:

    Standards evolve over time as new technologies emerge, and regulatory requirements change. The development of new standards involves a collaborative effort among stakeholders, including industry experts, regulators, and scientists.

    Standard Numbers and Scope:

    The following standard numbers and their scope are relevant to ASTM D7823:

  • ASTM D7823-18: This standard provides a test method for determining phthalates in plastic components using GC/MS.

  • ISO 18286:2015: This standard specifies the determination of phthalate esters in plastic materials using GC/MS.

    • Standard Compliance Requirements:

    Compliance with standards is mandatory for various industries, including:

  • Automotive

  • Aerospace

  • Electronics

  • Medical devices

    • Failure to comply with regulatory requirements can result in costly recalls, fines, and damage to reputation.

    Why this Test is Needed:

    The ASTM D7823 testing service is essential for ensuring the safety and compliance of plastic components. The presence of phthalates in plastic materials can pose health risks to humans and the environment.

    This section explains why the ASTM D7823 testing service is required, the business and technical reasons for conducting this test, and the consequences of not performing it.

    Why this Test is Required:

    Phthalates are widely used in plastic components due to their flexibility and durability. However, they can leach out of these materials and contaminate food, water, and soil. The presence of phthalates has been linked to various health issues, including cancer, reproductive problems, and developmental delays.

    Business and Technical Reasons:

    The ASTM D7823 testing service is required due to the following reasons:

  • Compliance with regulatory requirements

  • Protection of human health and the environment

  • Prevention of costly recalls and fines

  • Maintenance of customer confidence and trust

    • Consequences of Not Performing this Test:

    Failure to conduct the ASTM D7823 testing service can result in:

  • Non-compliance with regulatory requirements

  • Damage to reputation and brand image

  • Financial losses due to recalls, fines, and lawsuits

  • Harm to human health and the environment

    • Industries and Sectors that Require this Testing:

    The following industries and sectors require the ASTM D7823 testing service:

  • Automotive

  • Aerospace

  • Electronics

  • Medical devices

  • Food packaging

    • Risk Factors and Safety Implications:

    Phthalates pose significant risks to human health and the environment. The presence of phthalates in plastic components can lead to:

  • Cancer, reproductive problems, and developmental delays

  • Contamination of food, water, and soil

  • Damage to ecosystems and wildlife

    • Quality Assurance and Quality Control Aspects:

    The ASTM D7823 testing service involves rigorous quality assurance and control measures to ensure accurate results. These measures include:

  • Calibration and validation of equipment

  • Training of personnel

  • Use of certified reference materials

  • Implementation of quality management systems

    • Why this Test Contributes to Product Safety and Reliability:

    The ASTM D7823 testing service contributes to product safety and reliability by:

  • Ensuring compliance with regulatory requirements

  • Protecting human health and the environment

  • Preventing costly recalls and fines

    • This section provides an overview of the relevant standards, legal framework, and standard development organizations.

    Industries and Sectors that Require this Testing:

    The following industries and sectors require the ASTM D7823 testing service:

  • Automotive

  • Aerospace

  • Electronics

  • Medical devices

  • Food packaging

    • This section explains why the ASTM D7823 testing service is required, the business and technical reasons for conducting this test, and the consequences of not performing it.

    Why this Test is Needed:

    The ASTM D7823 testing service is essential for ensuring the safety and compliance of plastic components. The presence of phthalates in plastic materials can pose health risks to humans and the environment.

    Please let me continue with the rest of the sections if you would like.

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