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usp-601-aerosols-extractables-in-metered-dose-inhalers
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 <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 <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

USP <601> Aerosols Extractables in Metered Dose Inhalers: A Comprehensive Guide to Eurolabs Laboratory Testing Service

As the demand for inhalation medications continues to grow, ensuring the quality and safety of metered dose inhalers (MDIs) has become a pressing concern for pharmaceutical manufacturers. One critical aspect of MDI testing is the assessment of extractables, which refers to the analysis of potentially hazardous substances that can be released from the device during use. In this comprehensive guide, we will delve into the world of USP <601> Aerosols Extractables in Metered Dose Inhalers laboratory testing, exploring the standards, requirements, and methodologies involved.

Standard-Related Information

The United States Pharmacopeia (USP) is a non-profit organization that establishes public standards for pharmaceuticals, including inhalation medications. USP <601> Aerosols Extractables in Metered Dose Inhalers is a testing standard that outlines the requirements for evaluating extractables in MDIs. This standard is based on international guidelines and recommendations from organizations such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN).

International Standards

Some of the key international standards related to USP <601> Aerosols Extractables in Metered Dose Inhalers testing include:

  • ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes

  • ASTM E2537-12, Standard Guide for Extractables Testing of Pharmaceutical Equipment and Consumables

  • CEN/TS 16643-1:2009, Aerosol containers Part 1: Containers made from plastic materials

    • National Standards

    In addition to international standards, national regulations also play a crucial role in governing USP <601> Aerosols Extractables in Metered Dose Inhalers testing. Some of the key national standards include:

  • USP <601>, Aerosols Extractables in Metered Dose Inhalers

  • FDA Guidance for Industry: MDI Labeling (2016)

  • European Medicines Agency (EMA) Guidance on MDIs (2017)

    • Standard Development Organizations

    Standard development organizations (SDOs) such as ISO, ASTM, and CEN play a vital role in developing and maintaining international standards. These SDOs collaborate with industry experts, regulatory bodies, and other stakeholders to ensure that standards are relevant, effective, and up-to-date.

    Why This Test is Needed

    The assessment of extractables in MDIs is essential for ensuring the safety and quality of inhalation medications. Extractables can include a wide range of substances, including solvents, propellants, and leachates from device components. These substances can potentially cause adverse reactions or interact with other medications, compromising patient health.

    Business and Technical Reasons

    Conducting USP <601> Aerosols Extractables in Metered Dose Inhalers testing provides several business and technical benefits:

  • Ensures compliance with regulatory requirements

  • Provides a competitive advantage through quality assurance and safety

  • Supports product development and innovation

  • Enhances customer trust and confidence

    • Risk Factors and Safety Implications

    Failure to perform USP <601> Aerosols Extractables in Metered Dose Inhalers testing can result in serious consequences, including:

  • Regulatory non-compliance

  • Product recalls

  • Damage to brand reputation

  • Adverse reactions or interactions with other medications

    • Quality Assurance and Quality Control Aspects

    Eurolabs USP <601> Aerosols Extractables in Metered Dose Inhalers testing service is designed to ensure the highest level of quality assurance and control. Our laboratory follows strict protocols for sample preparation, testing, and reporting.

    Competitive Advantages

    Conducting USP <601> Aerosols Extractables in Metered Dose Inhalers testing with Eurolab provides several competitive advantages:

  • Accelerated testing times through state-of-the-art equipment

  • Expertise and experience in MDI testing

  • Flexible scheduling to accommodate tight deadlines

    • Cost-Benefit Analysis

    While conducting USP <601> Aerosols Extractables in Metered Dose Inhalers testing may seem like an additional expense, the benefits far outweigh the costs. By investing in this critical testing service, pharmaceutical manufacturers can:

  • Avoid costly product recalls and regulatory fines

  • Enhance customer trust and confidence

  • Stay ahead of competitors through quality assurance and safety

    • Test Conditions and Methodology

    Eurolabs USP <601> Aerosols Extractables in Metered Dose Inhalers testing service involves the following steps:

    1. Sample preparation: MDI devices are carefully prepared for testing, including filling and capping.

    2. Testing: Samples are analyzed using a combination of gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS).

    3. Reporting: Results are reported in accordance with USP <601> guidelines.

    Conclusion

    USP <601> Aerosols Extractables in Metered Dose Inhalers testing is a critical aspect of ensuring the safety and quality of inhalation medications. Eurolabs laboratory testing service provides expert analysis, state-of-the-art equipment, and flexible scheduling to accommodate tight deadlines. By investing in this critical testing service, pharmaceutical manufacturers can enhance customer trust and confidence, stay ahead of competitors through quality assurance and safety, and avoid costly product recalls and regulatory fines.

    References

  • USP <601>, Aerosols Extractables in Metered Dose Inhalers

  • ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes

  • ASTM E2537-12, Standard Guide for Extractables Testing of Pharmaceutical Equipment and Consumables

  • CEN/TS 16643-1:2009, Aerosol containers Part 1: Containers made from plastic materials

    • About Eurolab

    Eurolab is a leading provider of laboratory testing services, specializing in pharmaceutical and medical device testing. Our expert analysts and state-of-the-art equipment ensure the highest level of quality assurance and control for our clients.

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