EUROLAB
astm-d8147-non-volatile-extractables-in-polymeric-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 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 D8147 Non-Volatile Extractables in Polymeric Materials Laboratory Testing Service: A Comprehensive Guide

The ASTM D8147 standard is a widely accepted method for testing non-volatile extractables in polymeric materials. This standard is part of the American Society for Testing and Materials (ASTM) portfolio, which provides a framework for developing, evaluating, and publishing technical standards related to various industries.

1.1. International and National Standards

The ASTM D8147 standard is influenced by international and national standards that govern laboratory testing in general and polymeric materials specifically. Some of the relevant standards include:

  • ISO 17025:2005 (General requirements for the competence of testing and calibration laboratories)

  • EN 71 (Safety of toys): This standard sets limits for non-volatile extractables in polymeric materials used in toys.

  • TSE 1333 (Safety of toys): This Turkish standard is similar to EN 71 and specifies limits for non-volatile extractables.

    • 1.2. Standard Development Organizations

    The ASTM D8147 standard was developed by the ASTM Committee on Polymers, which is responsible for creating standards related to polymers. The committee consists of experts from various industries, including academia, research institutions, and industry representatives.

    1.3. Standard Evolution and Updates

    Standards evolve over time as new technologies and methodologies become available. The ASTM D8147 standard has undergone revisions in the past, with the most recent update occurring in Year. This revision included changes to sample preparation procedures and testing parameters.

    Table 1: Standard Numbers and Scope

    Standard Number Title

    --- ---

    ASTM D8147 Standard Test Method for Non-Volatile Extractables in Polymeric Materials

    ISO 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories

    EN 71 Safety of Toys

    1.4. Compliance Requirements

    Different industries have varying compliance requirements for non-volatile extractables testing. For example:

  • The European Unions Restriction of Hazardous Substances (RoHS) Directive requires that electronic and electrical equipment manufacturers test their products for non-volatile extractables.

  • The United States Consumer Product Safety Improvement Act (CPSIA) mandates that toy manufacturers conduct non-volatile extractables testing to ensure compliance with safety standards.

    • 1.5. Legal and Regulatory Framework

    The ASTM D8147 standard is governed by the legal and regulatory framework surrounding laboratory testing in general. This includes:

  • ISO 17025:2005, which sets requirements for laboratory competence

  • Accreditation bodies such as the American Association of Laboratory Accreditation (A2LA) and the International Accreditation Forum (IAF)

    • The ASTM D8147 standard is required to ensure product safety, quality, and regulatory compliance in various industries.

    2.1. Business and Technical Reasons for Testing

    Non-volatile extractables testing is necessary because:

  • It helps manufacturers identify potential health risks associated with exposure to certain chemicals

  • It ensures compliance with industry-specific regulations and standards

  • It supports quality assurance and control programs by identifying contaminants and impurities in polymeric materials

    • 2.2. Consequences of Not Performing This Test

    Failing to conduct non-volatile extractables testing can result in:

  • Product recalls due to safety concerns

  • Reputation damage and loss of customer trust

  • Non-compliance with industry regulations, leading to fines and penalties

    • Table 2: Industries Requiring ASTM D8147 Testing

    Industry Description

    --- ---

    Toys Polymeric materials used in toys must comply with EN 71 standards

    Electronics Electronic components require RoHS compliance testing

    Medical Devices Polymeric materials used in medical devices must be tested for extractables

    2.3. Quality Assurance and Control

    Non-volatile extractables testing contributes to product safety and reliability by:

  • Identifying potential contaminants and impurities

  • Ensuring compliance with industry-specific regulations and standards

    • 2.4. Cost-Benefit Analysis

    Performing non-volatile extractables testing can provide significant benefits, including:

  • Reduced risk of product recalls and reputation damage

  • Improved quality assurance and control programs

  • Enhanced customer confidence and trust

  • Increased market access through regulatory compliance

    • Table 3: Competitive Advantages

    Advantage Description

    --- ---

    Product Safety Compliance with industry-specific regulations and standards

    Quality Assurance Identification of potential contaminants and impurities in polymeric materials

    Market Access Increased customer confidence and trust, leading to increased market share

    The ASTM D8147 standard specifies the testing conditions and methodology for non-volatile extractables in polymeric materials.

    3.1. Sample Preparation

    Sample preparation involves:

  • Weighing and preparing a representative sample of the polymeric material

  • Cutting or grinding the sample into small pieces to increase surface area

  • Removing any contaminants or impurities using solvents or other methods

    • Table 4: Testing Parameters

    Parameter Description

    --- ---

    Extraction Time The time required for extraction of non-volatile extractables from polymeric materials

    Temperature The temperature at which the extraction is performed

    Solvent The solvent used to extract non-volatile extractables

    3.2. Testing Equipment and Materials

    The testing equipment and materials required include:

  • A Soxhlet apparatus or other extraction device

  • A rotary evaporator for drying the extracted sample

  • Solvents, such as hexane or dichloromethane, for extracting non-volatile extractables

    • Table 5: Quality Control Measures

    Measure Description

    --- ---

    Calibration Regular calibration of testing equipment to ensure accuracy and precision

    Validation Validation of testing procedures and protocols to ensure compliance with industry standards

    This comprehensive guide has provided an overview of the ASTM D8147 standard, including its development, scope, and requirements. By following this guide, manufacturers can ensure that their polymeric materials comply with industry-specific regulations and standards, reducing the risk of product recalls and reputation damage.

    4. CONCLUSION

    The ASTM D8147 standard is a widely accepted method for testing non-volatile extractables in polymeric materials. This standard ensures compliance with industry-specific regulations and standards, reduces the risk of product recalls and reputation damage, and supports quality assurance and control programs by identifying contaminants and impurities in polymeric materials.

    APPENDIX

    A list of relevant standards and guidelines related to non-volatile extractables testing is provided below:

  • ASTM D8147: Standard Test Method for Non-Volatile Extractables in Polymeric Materials

  • ISO 17025:2005: General Requirements for the Competence of Testing and Calibration Laboratories

  • EN 71: Safety of Toys

  • TSE 1333: Safety of Toys

    • This comprehensive guide has provided an overview of the ASTM D8147 standard, including its development, scope, and requirements. By following this guide, manufacturers can ensure that their polymeric materials comply with industry-specific regulations and standards, reducing the risk of product recalls and reputation damage.

    Please let me know if you would like me to make any changes or additions!

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers