EUROLAB
21-cfr-1771630-polyethylene-terephthalate-polymers-leachables-limit
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 PolyolefinsASTM 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 6.07 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 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit Laboratory Testing Service Provided by Eurolab

The testing service provided by Eurolab for 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit is governed by a range of international and national standards. These standards are developed and published by organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), Turkish Standards Institution (TSE), and others.

Legal and Regulatory Framework

The 21 CFR 177.1630 standard is part of the United States Code of Federal Regulations, which outlines the requirements for polyethylene terephthalate (PET) polymers used in food contact applications. The standard specifies the permissible levels of leachables from PET materials into food.

International and National Standards

The relevant international standards governing 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit testing include:

  • ISO 10993-18: Biological evaluation of medical devices - Part 18: Chemical characterization of materials

  • ASTM F2393: Standard Practice for Evaluation of Extractables from Food Contact Packaging Materials

  • CEN/TS 16540: Plastics Piping Systems and Fittings Polyethylene (PE) pipes, fittings, valves and other equipment

    • National standards specific to the United States include:

  • 21 CFR 177.1630: Polymers - Polyethylene Terephthalate (PET)

  • NSF/ANSI 51: Food Equipment Materials

  • USDA Compliance Program for Sanitary Transportation of Meat, Poultry, and Egg Products

    • Standard Development Organizations

    Standard development organizations play a crucial role in creating and maintaining standards. These organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations ensure that standards are developed, reviewed, and updated regularly to reflect the latest scientific knowledge and technological advancements.

    Standard Evolution and Update

    Standards evolve over time as new technologies emerge and scientific knowledge advances. Eurolab stays up-to-date with the latest standard developments and updates to ensure that our laboratory testing services meet the most current requirements.

    Relevant Standard Numbers and Scope

    The following are some relevant standard numbers and their scope:

  • ISO 10993-18: Biological evaluation of medical devices - Part 18: Chemical characterization of materials

    • Scope: This standard specifies a method for evaluating the extractables from medical device materials.

  • ASTM F2393: Standard Practice for Evaluation of Extractables from Food Contact Packaging Materials

    • Scope: This standard provides a guide for evaluating extractables from food contact packaging materials.

  • CEN/TS 16540: Plastics Piping Systems and Fittings Polyethylene (PE) pipes, fittings, valves and other equipment

    • Scope: This standard specifies the requirements for polyethylene piping systems.

    Standard Compliance Requirements

    Different industries have varying compliance requirements for standards related to 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit testing. For example:

  • Food packaging industry: Comply with 21 CFR 177.1630, NSF/ANSI 51, and USDA Compliance Program for Sanitary Transportation of Meat, Poultry, and Egg Products.

  • Medical device industry: Comply with ISO 10993-18 and ASTM F2393.

    • Eurolabs laboratory testing services ensure compliance with these standards to help industries meet regulatory requirements.

    The need for 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit testing arises from the importance of ensuring that PET materials do not leach harmful substances into food or medical devices. This test is required by regulatory agencies to ensure product safety and reliability.

    Business and Technical Reasons for Testing

    The business and technical reasons for conducting 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit testing include:

  • Ensuring compliance with regulatory requirements

  • Protecting consumers from potential health risks associated with leachable substances

  • Maintaining product quality and reliability

  • Enhancing brand reputation and customer confidence

    • Consequences of Not Performing This Test

    Not performing this test can lead to serious consequences, including:

  • Regulatory non-compliance and potential fines or penalties

  • Product recalls and loss of market share

  • Damage to brand reputation and customer trust

    • Eurolabs laboratory testing services help industries avoid these consequences by ensuring compliance with regulatory requirements.

    Leachables Limit Testing

    The 21 CFR 177.1630 standard specifies the permissible levels of leachables from PET materials into food. Eurolabs laboratory testing services ensure that these limits are met to protect consumers and maintain product quality and reliability.

    Test Methods and Procedures

    Eurolab uses standardized test methods and procedures for 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit testing, including:

  • Extraction of PET materials using solvents or other methods

  • Analysis of extractables by techniques such as gas chromatography (GC) or liquid chromatography-mass spectrometry (LC-MS)

    • Eurolabs experienced technicians and state-of-the-art equipment ensure accurate and reliable test results.

    Standard Compliance and Regulatory Requirements

    Eurolab is committed to ensuring compliance with regulatory requirements for 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit testing. Our laboratory testing services meet the most current standards and regulations, including:

  • 21 CFR 177.1630

  • NSF/ANSI 51

  • USDA Compliance Program for Sanitary Transportation of Meat, Poultry, and Egg Products

    • By working with Eurolab, industries can ensure compliance with regulatory requirements and maintain product quality and reliability.

    Standard Evolution and Update

    Standards evolve over time as new technologies emerge and scientific knowledge advances. Eurolab stays up-to-date with the latest standard developments and updates to ensure that our laboratory testing services meet the most current requirements.

    Conclusion

    Leachables Limit Testing

    Eurolabs laboratory testing services for 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit include:

  • Extraction of PET materials using solvents or other methods

  • Analysis of extractables by techniques such as gas chromatography (GC) or liquid chromatography-mass spectrometry (LC-MS)

    • Eurolabs experienced technicians and state-of-the-art equipment ensure accurate and reliable test results.

    Test Methods and Procedures

    Eurolab uses standardized test methods and procedures for 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit testing, including:

  • Extraction of PET materials using solvents or other methods

  • Analysis of extractables by techniques such as gas chromatography (GC) or liquid chromatography-mass spectrometry (LC-MS)

    • Eurolabs experienced technicians and state-of-the-art equipment ensure accurate and reliable test results.

    Standard Compliance and Regulatory Requirements

    Eurolab is committed to ensuring compliance with regulatory requirements for 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit testing. Our laboratory testing services meet the most current standards and regulations, including:

  • 21 CFR 177.1630

  • NSF/ANSI 51

  • USDA Compliance Program for Sanitary Transportation of Meat, Poultry, and Egg Products

    • By working with Eurolab, industries can ensure compliance with regulatory requirements and maintain product quality and reliability.

    Conclusion

    References

  • 21 CFR 177.1630: Polymers - Polyethylene Terephthalate (PET)

  • NSF/ANSI 51: Food Equipment Materials

  • USDA Compliance Program for Sanitary Transportation of Meat, Poultry, and Egg Products

  • ISO 10993-18: Biological evaluation of medical devices - Part 18: Chemical characterization of materials

  • ASTM F2393: Standard Practice for Evaluation of Extractables from Food Contact Packaging Materials

  • CEN/TS 16540: Plastics Piping Systems and Fittings Polyethylene (PE) pipes, fittings, valves and other equipment

    • Please note that this is a comprehensive guide and not an exhaustive list. For more information or specific requirements, please contact Eurolab directly.

    Eurolabs Laboratory Testing Services

    Eurolab offers a range of laboratory testing services for 21 CFR 177.1630 Polyethylene Terephthalate Polymers Leachables Limit, including:

  • Extraction of PET materials using solvents or other methods

  • Analysis of extractables by techniques such as gas chromatography (GC) or liquid chromatography-mass spectrometry (LC-MS)

    • Eurolabs experienced technicians and state-of-the-art equipment ensure accurate and reliable test results.

    Contact Us

    For more information about Eurolabs laboratory testing services, please contact us directly:

    Email: infoeurolab.com(mailto:infoeurolab.com)

    Phone: 1 800 123 4567

    Fax: 1 800 123 4568

    Conclusion

    This is a comprehensive guide, please let me know if you need more information or specific requirements.

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

    CONTACT US +902127020000

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