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astm-f3136-evaluation-of-leachables-in-drug-delivery-devices
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 ComponentsEMA 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 F3136 Evaluation of Leachables in Drug Delivery Devices Laboratory Testing Service: A Comprehensive Guide

The evaluation of leachables in drug delivery devices is a critical aspect of ensuring the safety and efficacy of medical products. The ASTM F3136 standard provides a comprehensive framework for testing and evaluating the potential leachables from these devices.

Legal and Regulatory Framework

Regulatory agencies, such as the US FDA and EU authorities, require manufacturers to demonstrate that their drug delivery devices meet specific standards for safety and performance. The evaluation of leachables is an essential component of this process.

  • US FDA: 21 CFR Part 801 requires that medical products be safe and effective.

  • EU Authorities: The EU Medical Devices Regulation (MDR) 2017/745 sets out requirements for the safety, performance, and labeling of medical devices.

  • ISO Standards: ISO 10993-18:2020 provides guidelines for testing and evaluation of medical device leachables.

    • Standard Requirements and Needs

    The need for ASTM F3136 Evaluation of Leachables in Drug Delivery Devices testing arises from the potential risks associated with leachable substances. These risks include:

  • Toxicity: Leachable substances can be toxic to patients, leading to adverse reactions or even death.

  • Biocompatibility: Leachable substances may not be biocompatible with human tissue, potentially causing inflammation or damage.

    • Industries and Sectors Requiring Testing

    The following industries and sectors require ASTM F3136 Evaluation of Leachables in Drug Delivery Devices testing:

  • Pharmaceuticals: Manufacturers of pharmaceutical products that use drug delivery devices must demonstrate compliance with regulatory requirements.

  • Medical Device Industry: Manufacturers of medical devices, including implantable devices, diagnostic equipment, and wound care products, require leachable evaluation to ensure safety and efficacy.

  • Research and Development: Researchers developing new medical products or technologies may need to conduct leachable evaluation studies.

    • Quality Assurance and Compliance Benefits

    Conducting ASTM F3136 Evaluation of Leachables in Drug Delivery Devices testing provides numerous benefits, including:

  • Ensuring Safety: Evaluating potential leachables helps ensure that medical products are safe for patients.

  • Compliance: Meeting regulatory requirements demonstrates compliance with industry standards.

  • Quality Assurance: Conducting thorough testing and evaluation enhances the overall quality of medical products.

    • The ASTM F3136 Evaluation of Leachables in Drug Delivery Devices testing involves several steps:

    Sample Preparation Procedures

    1. Device Selection: Select a representative device sample.

    2. Sterilization: Sterilize the device using an approved method (e.g., gamma irradiation, ethylene oxide).

    3. Extraction: Extract potential leachables from the device using an appropriate solvent (e.g., water, saline solution).

    Testing Parameters and Conditions

    1. Temperature: Conduct testing at a temperature range of 20C to 50C.

    2. Humidity: Maintain a relative humidity of 40 to 60.

    3. Exposure Time: Expose the device for a minimum of 24 hours.

    Measurement and Analysis Methods

    1. Chromatographic Techniques: Use techniques such as HPLC or GC-MS for detection and quantification of leachables.

    2. Spectroscopic Techniques: Employ spectroscopic methods, including IR, NMR, and MS, to identify and quantify leachable substances.

    Calibration and Validation Procedures

    1. Calibration: Calibrate equipment according to manufacturers instructions.

    2. Validation: Validate testing protocols using certified reference materials (CRMs).

    The test report should include:

  • Summary: Briefly summarize the testing objectives, methods, and results.

  • Testing Parameters: List all testing parameters, including temperature, humidity, exposure time, and sample preparation procedures.

  • Results: Present results in a clear, concise manner, using tables or figures to facilitate understanding.

    • Reporting Standards and Formats

    1. ISO 17025: Follow ISO/IEC 17025:2018 for laboratory testing and calibration.

    2. EU MDR: Comply with EU Medical Devices Regulation (MDR) requirements for reporting and documentation.

    Why This Test Should Be Performed

    Performing ASTM F3136 Evaluation of Leachables in Drug Delivery Devices testing provides numerous benefits, including:

  • Ensuring Safety: Evaluating potential leachables helps ensure that medical products are safe for patients.

  • Compliance: Meeting regulatory requirements demonstrates compliance with industry standards.

  • Quality Assurance: Conducting thorough testing and evaluation enhances the overall quality of medical products.

    • Why Choose Our Laboratory

    Our laboratory offers expert analysis, state-of-the-art equipment, and comprehensive reporting to ensure that your ASTM F3136 Evaluation of Leachables in Drug Delivery Devices testing meets all regulatory requirements.

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

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