EUROLAB
usp-1086-impurities-extractables-risk-profiling
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 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 <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 USP <1086> Impurities Extractables Risk Profiling Testing Services Provided by Eurolab

Standard-Related Information

USP <1086> Impurities Extractables Risk Profiling testing is a laboratory test that assesses the potential risks associated with extractable impurities in pharmaceutical and medical device products. The relevant standards for this testing service are outlined below:

  • ISO 10993: Biological evaluation of medical devices

  • ASTM E2187: Standard Practice for Assessing the Safety of Medical Devices Containing Materials or Metals Subject to Release

  • EN 581: Chemicals, materials, and articles in contact with foodstuffs - Plastics and rubber

    • The legal and regulatory framework surrounding this testing service is governed by various international and national standards. The primary goal of these standards is to ensure the safety and efficacy of medical devices and pharmaceutical products.

    International Standards

  • ISO 10993: This standard provides guidelines for the biological evaluation of medical devices, including the assessment of extractable impurities.

  • ASTM E2187: This standard outlines a practice for assessing the safety of medical devices containing materials or metals subject to release.

  • EN 581: This standard sets out requirements for plastics and rubber in contact with foodstuffs.

    • National Standards

  • USP <1086>: This standard provides guidelines for the assessment of extractable impurities in pharmaceutical products.

  • FDA Guidance Document on Extractables and Leachables (EL) Testing

    • Standard Development Organizations

    The following organizations are involved in the development and maintenance of standards related to USP <1086> Impurities Extractables Risk Profiling testing:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution and Updates

    Standards evolve over time as new technologies and research become available. Organizations such as ISO, ASTM, and CEN regularly review and update their standards to reflect the latest developments in the field.

    Standard Numbers and Scope

    The following standard numbers and scope are relevant to USP <1086> Impurities Extractables Risk Profiling testing:

  • ISO 10993:2010 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

  • ASTM E2187-08 Standard Practice for Assessing the Safety of Medical Devices Containing Materials or Metals Subject to Release

    • Standard Compliance Requirements

    Compliance with these standards is mandatory in various industries, including:

  • Pharmaceuticals

  • Medical Devices

  • Food Contact Materials

    • Failure to comply with standard requirements can result in product recalls, regulatory penalties, and damage to reputation.

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    Standard Requirements and Needs

    USP <1086> Impurities Extractables Risk Profiling testing is required for a variety of reasons:

  • Business and Technical Reasons: The test is necessary to ensure the safety and efficacy of medical devices and pharmaceutical products.

  • Consequences of Not Performing the Test: Failure to conduct this test can result in product recalls, regulatory penalties, and damage to reputation.

  • Industries and Sectors Requiring Testing: Pharmaceuticals, Medical Devices, Food Contact Materials

  • Risk Factors and Safety Implications: Extractable impurities can pose risks to human health and safety.

    • The quality assurance and quality control aspects of this test are crucial in ensuring the accuracy and reliability of results. This testing contributes to product safety and reliability by identifying potential hazards associated with extractable impurities.

    Competitive Advantages and Cost-Benefit Analysis

    Performing USP <1086> Impurities Extractables Risk Profiling testing provides several competitive advantages, including:

  • Improved Product Safety: Reduces the risk of product recalls and regulatory penalties

  • Enhanced Customer Confidence: Builds trust with customers through transparency and compliance

  • Increased Market Access: Facilitates international trade by demonstrating compliance with regulations

    • The cost-benefit analysis of performing this test is favorable due to the potential savings in product recall costs, regulatory fines, and damage to reputation.

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    Test Conditions and Methodology

    The following conditions and methodology are used for USP <1086> Impurities Extractables Risk Profiling testing:

  • Testing Equipment: GC-MS, ICP-MS

  • Sample Preparation: Sample extraction and analysis using the aforementioned equipment

  • Testing Parameters: Temperature, pressure, humidity

  • Measurement and Analysis Methods: GC-MS, ICP-MS

  • Calibration and Validation Procedures: Regular calibration and validation of testing equipment

    • Quality control measures during testing include:

  • Data Collection and Recording: Accurate and detailed recording of test results

  • Testing Timeframes and Duration: Testing is performed according to established timeframes and duration

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    Test Reporting and Documentation

    The following information is included in the test report:

  • Report Format and Structure: Standardized report format with clear headings and sections

  • Detailed Results: Accurate and detailed recording of test results

  • Conclusion and Recommendations: Summary of findings and recommendations for further action

    • The test report is essential in demonstrating compliance with regulations and ensuring product safety.

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    Conclusion

    USP <1086> Impurities Extractables Risk Profiling testing is a crucial step in ensuring the safety and efficacy of medical devices and pharmaceutical products. By understanding the standard-related information, requirements, and methodology involved in this testing service, organizations can ensure compliance with regulations and reduce risks associated with extractable impurities.

    Recommendations

  • Perform regular testing to identify potential hazards associated with extractable impurities

  • Maintain accurate records of test results and calibration/validation procedures

  • Comply with regulatory requirements and industry standards for extractables and leachables (EL) testing

    • By following these recommendations, organizations can ensure the safety and efficacy of their products while maintaining compliance with regulations.

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