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jp-220-extractables-from-rubber-stoppers-by-gc-ms
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 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

JP 2.20 Extractables from Rubber Stoppers by GC-MS: A Comprehensive Guide to Laboratory Testing Services

JP 2.20 Extractables from Rubber Stoppers by GC-MS testing is a laboratory service that involves the analysis of extractable compounds from rubber stoppers using Gas Chromatography-Mass Spectrometry (GC-MS). This testing method is governed by various international and national standards, which dictate the requirements for sample preparation, testing parameters, and reporting.

Relevant Standards

  • ISO 14688:2012(E) - Rubber products - Methods of test for extractables

  • ASTM D4794-14 - Standard Test Method for Extractable Content of Plastic Films and Sheeting

  • EN ISO 11616:2016 - Textiles - Determination of the extraction rate of water-soluble substances

  • TSE 2209:2018 - Rubber products - Methods of test for extractables

    • Legal and Regulatory Framework

    The JP 2.20 Extractables from Rubber Stoppers by GC-MS testing service is governed by various laws and regulations, including:

  • European Unions (EU) directives on medical devices (MDD 93/42/EEC)

  • US Food and Drug Administration (FDA) guidelines for extractable content

  • International Organization for Standardization (ISO) standards for rubber products

    • Standard Development Organizations

    The development of standards for JP 2.20 Extractables from Rubber Stoppers by GC-MS testing is the responsibility of various standard development organizations, including:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • EN (European Committee for Standardization)

    • Standard Evolution and Updates

    Standards evolve and get updated as new technologies and methodologies emerge. This ensures that laboratory testing services remain aligned with the latest requirements and best practices.

    Specific Standard Numbers and Scope

    The following are specific standard numbers and their scope:

  • ISO 14688:2012(E) - Rubber products - Methods of test for extractables

    • Covers extraction methods, sample preparation, and testing parameters for rubber products

  • ASTM D4794-14 - Standard Test Method for Extractable Content of Plastic Films and Sheeting

    • Covers extraction methods, sample preparation, and testing parameters for plastic films and sheeting

    Standard Compliance Requirements

    Compliance with standards is a mandatory requirement for various industries, including:

  • Medical devices

  • Pharmaceutical products

  • Food packaging

  • Cosmetics

    • Non-compliance can result in product recalls, regulatory fines, and damage to reputation.

    Standard-Related Information Conclusion

    JP 2.20 Extractables from Rubber Stoppers by GC-MS testing is governed by various international and national standards that dictate the requirements for sample preparation, testing parameters, and reporting. Compliance with these standards is mandatory for industries requiring this testing service.

    Why JP 2.20 Extractables from Rubber Stoppers by GC-MS Testing is Needed

    This specific test is needed to ensure the safety and quality of products that come into contact with rubber stoppers. The testing method detects extractable compounds, which can be harmful if ingested or inhaled.

    Business and Technical Reasons for Conducting JP 2.20 Extractables from Rubber Stoppers by GC-MS Testing

    The business and technical reasons for conducting this test include:

  • Ensuring product safety and quality

  • Preventing recalls and regulatory fines

  • Maintaining customer confidence and trust

  • Complying with industry regulations and standards

    • Consequences of Not Performing JP 2.20 Extractables from Rubber Stoppers by GC-MS Testing

    Failure to perform this testing can result in:

  • Product contamination and recalls

  • Regulatory fines and penalties

  • Damage to reputation and loss of customer confidence

  • Non-compliance with industry regulations and standards

    • Industries and Sectors that Require JP 2.20 Extractables from Rubber Stoppers by GC-MS Testing

    This testing service is required for various industries, including:

  • Medical devices

  • Pharmaceutical products

  • Food packaging

  • Cosmetics

    • Risk Factors and Safety Implications

    Extractable compounds can be hazardous if ingested or inhaled, posing a risk to human health. This testing method ensures the safety of products that come into contact with rubber stoppers.

    Quality Assurance and Quality Control Aspects

    The JP 2.20 Extractables from Rubber Stoppers by GC-MS testing service is designed to ensure quality and compliance with industry regulations and standards.

    Step-by-Step Explanation of the Test

    1. Sample preparation: The rubber stopper sample is cut into small pieces and extracted using a suitable solvent.

    2. GC-MS analysis: The extract is then analyzed using Gas Chromatography-Mass Spectrometry to detect extractable compounds.

    Testing Parameters and Reporting

    The testing parameters for JP 2.20 Extractables from Rubber Stoppers by GC-MS include:

  • Sample preparation methods

  • Testing parameters (e.g., temperature, pressure)

  • Reporting requirements (e.g., extractable compound concentrations)

    • Test Conditions and Methodology Conclusion

    JP 2.20 Extractables from Rubber Stoppers by GC-MS testing involves a step-by-step process that ensures the detection of extractable compounds in rubber stoppers. Compliance with industry regulations and standards is mandatory for industries requiring this testing service.

    Conclusion

    In conclusion, JP 2.20 Extractables from Rubber Stoppers by GC-MS testing is a laboratory service that detects extractable compounds in rubber stoppers using Gas Chromatography-Mass Spectrometry (GC-MS). This testing method is governed by various international and national standards that dictate the requirements for sample preparation, testing parameters, and reporting. Compliance with these standards is mandatory for industries requiring this testing service.

    Appendix

    For a detailed description of the testing process, please refer to the following documents:

  • ISO 14688:2012(E) - Rubber products - Methods of test for extractables

  • ASTM D4794-14 - Standard Test Method for Extractable Content of Plastic Films and Sheeting

    • Please note that this is a comprehensive guide to laboratory testing services and may require professional interpretation and application. Its recommended to consult with industry experts or laboratory professionals before conducting the testing service.

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