EUROLAB
21-cfr-1771520-leachable-migration-limits-for-polyolefins
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 177.1630 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 6.07 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 177.1520 Leachable Migration Limits for Polyolefins Testing Services Provided by Eurolab

The testing of polyolefin materials for leachable migration limits is governed by various international and national standards. The most relevant standards that apply to this specific laboratory test are:

  • ISO 10993-18:2011 Biological evaluation of medical devices - Part 18: Chemical characterization of materials

  • ASTM F963-17 Standard Consumer Product Safety Specification for Toy Safety

  • EN 71:2018 A12:2020 Safety of toys - Part 3: Specific requirements for toys containing chemical substances

  • TSE (Turkish Standards Institution) TS 11621:2017 Toy safety - Safety aspects related to materials, physical and sensory characteristics

    • These standards outline the testing requirements for polyolefin materials used in various applications, including medical devices, consumer products, and toys. The legal and regulatory framework surrounding this testing service is governed by:

  • The European Unions (EU) Medical Device Regulation (MDR) 2017/745

  • The EUs Toy Safety Directive (TSD) 2009/48/EC

  • The US FDAs guidance on testing for leachable migration limits

    • Eurolab, as a leading laboratory testing service provider, is committed to ensuring compliance with these standards and regulations.

    The specific test for 21 CFR 177.1520 Leachable Migration Limits for Polyolefins is required by various industries, including:

  • Medical device manufacturers

  • Consumer product companies

  • Toy safety testing organizations

    • This test is necessary to ensure that polyolefin materials used in these applications meet the required safety standards and regulations.

    The 21 CFR 177.1520 Leachable Migration Limits for Polyolefins testing service provided by Eurolab involves the following steps:

    1. Sample preparation: The polyolefin material is prepared according to the specified test method.

    2. Testing equipment and instruments: The test is conducted using specialized equipment, including extraction cells, high-performance liquid chromatography (HPLC) systems, and mass spectrometers.

    3. Testing environment requirements:

    Temperature: 23C 2C

    Humidity: 50 10

    Pressure: Atmospheric pressure

    4. Sample preparation procedures:

    Cut samples into small pieces

    Extract the sample using a solvent (e.g., methanol or water)

    5. Testing parameters and conditions:

    Extraction time: 24 hours

    Solvent flow rate: 1 mL/min

    Detection limit: 0.01 mg/L

    6. Measurement and analysis methods:

    HPLC-MS/MS (High-performance liquid chromatography-tandem mass spectrometry)

    Gas chromatography-mass spectrometry (GC-MS)

    Eurolabs laboratory is equipped with state-of-the-art equipment, including:

  • Thermo Scientific Vanquish Ultra UHPLC system

  • Agilent 6460 Triple Quadrupole LC/MS System

    • The test results are documented and reported according to the following format:

    1. Test report: A comprehensive report detailing the test methodology, sample preparation procedures, testing parameters and conditions, measurement and analysis methods, and results.

    2. Certificate of compliance: A document confirming that the polyolefin material meets the required leachable migration limits for 21 CFR 177.1520.

    The reporting standards and formats used by Eurolab include:

  • ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories

  • EUs Medical Device Regulation (MDR) 2017/745, Annex I

    • Performing the 21 CFR 177.1520 Leachable Migration Limits for Polyolefins testing service provided by Eurolab offers numerous benefits and advantages:

    1. Risk assessment and mitigation: Ensures that polyolefin materials used in various applications meet the required safety standards.

    2. Quality assurance and compliance: Demonstrates compliance with international and national standards, ensuring product safety and reliability.

    3. Competitive advantages: Enhances customer confidence and trust by demonstrating a commitment to quality and safety.

    Eurolab is uniquely positioned to provide this service due to its:

    1. Expertise and experience in the field of leachable migration limits testing

    2. State-of-the-art equipment and facilities

    3. Qualified and certified personnel

    4. Accreditation and certification details:

    ISO/IEC 17025:2018 accreditation

    EUs Medical Device Regulation (MDR) 2017/745 compliance

    Eurolab is committed to ensuring the accuracy, reliability, and timeliness of its test results.

    Conclusion

    The 21 CFR 177.1520 Leachable Migration Limits for Polyolefins testing service provided by Eurolab is essential for ensuring product safety and reliability in various industries. By following this comprehensive guide, manufacturers can ensure compliance with international and national standards, enhancing customer confidence and trust.

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

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