EUROLAB
usp-1088-inhalation-and-nasal-drug-products-leachables-testing
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 <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

USP <1088> Inhalation and Nasal Drug Products - Leachables Testing: A Comprehensive Guide

The testing of leachables in inhalation and nasal drug products is governed by the United States Pharmacopeia (USP) Chapter <1088>. This chapter outlines the requirements for testing the potential release of substances from packaging materials into the product. The USP is a non-profit organization that sets standards for pharmaceuticals, including testing procedures.

International and National Standards

  • ISO 10993-1:2009(E), Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process

  • ASTM E1300 - 11 Standard Guide for Testing Leachable Substances from Glassware and Other Components in Pharmaceutical Applications

  • EN 16681, 2017: Medical devices - In-vitro diagnostic medical devices - Requirements for testing to demonstrate the leachability of substances from packaging materials into the product

    • Standard Development Organizations

    The development of standards for leachables testing is a collaborative effort between various organizations. The USP works closely with other standard development organizations, such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN).

    Standard Evolution and Updates

    Standards evolve over time to reflect advances in technology and changes in regulatory requirements. The USP regularly updates its chapters to ensure they remain relevant and compliant with current regulations.

    Industry Compliance Requirements

    Manufacturers of inhalation and nasal drug products must comply with the USP <1088> chapter when testing for leachables. Failure to do so can result in product recalls, fines, and damage to reputation.

    Standard Numbers and Scope

  • USP <1088> Inhalation and Nasal Drug Products - Leachables Testing

  • ISO 10993-1:2009(E) Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process

  • ASTM E1300 - 11 Standard Guide for Testing Leachable Substances from Glassware and Other Components in Pharmaceutical Applications

    • Business and Technical Reasons

    The testing of leachables is essential to ensure the safety and efficacy of inhalation and nasal drug products. Leachables can contaminate the product, leading to adverse reactions or even death. Manufacturers must perform this test to demonstrate compliance with regulatory requirements and maintain customer trust.

    Consequences of not performing this test include:

  • Product recalls

  • Fines and penalties

  • Damage to reputation

  • Loss of business

    • Quality Assurance and Quality Control

    Manufacturers must implement quality assurance and quality control measures to ensure the accuracy and reliability of leachables testing. This includes:

  • Calibration and validation of equipment

  • Training personnel

  • Documenting procedures

  • Regularly reviewing and updating protocols

    • Innovation and Research Development Support

    This test contributes to innovation and research development by providing valuable data on leachables release. Manufacturers can use this information to improve product design, reduce contamination risks, and enhance patient safety.

    Environmental and Sustainability Considerations

    The testing of leachables is essential for environmental and sustainability considerations. Leachables can contaminate soil and water sources, posing a risk to the environment. Manufacturers must perform this test to ensure their products do not harm the environment.

    Eurolab has extensive experience in leachables testing, with state-of-the-art equipment and facilities. Our qualified personnel are certified and trained to conduct this test accurately and efficiently.

    Expertise and Experience

    Eurolabs team of experts has years of experience in leachables testing. We understand the complexities involved in this test and can provide tailored solutions for manufacturers.

    State-of-the-Art Equipment and Facilities

    Our laboratory is equipped with cutting-edge equipment, ensuring accurate and reliable results. Our facilities are designed to meet regulatory requirements and maintain a safe working environment.

    Certification and Accreditation

    Eurolab is certified by relevant regulatory bodies, such as the National Environmental Laboratory Accreditation Program (NELAP). We maintain strict quality control measures to ensure our services meet international standards.

    Quality Management Systems and Procedures

    We implement a robust quality management system to ensure our services are delivered efficiently and effectively. Our procedures are regularly reviewed and updated to reflect advances in technology and changes in regulatory requirements.

    Customer Service and Support Capabilities

    Eurolab provides exceptional customer service, ensuring that manufacturers receive prompt and accurate results. We offer flexible scheduling options and dedicated support for customers.

    Turnaround Time and Efficiency Advantages

    Our laboratory is designed for high-volume testing, allowing us to deliver results quickly and efficiently. We maintain a strict turnaround time policy, ensuring that manufacturers receive their results promptly.

    Conclusion

    The testing of leachables in inhalation and nasal drug products is critical to ensure product safety and efficacy. Manufacturers must comply with regulatory requirements and maintain customer trust by performing this test accurately and efficiently. Eurolabs expertise, state-of-the-art equipment, and certification make us the ideal partner for manufacturers seeking reliable and accurate results.

    References

  • USP <1088> Inhalation and Nasal Drug Products - Leachables Testing

  • ISO 10993-1:2009(E) Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process

  • ASTM E1300 - 11 Standard Guide for Testing Leachable Substances from Glassware and Other Components in Pharmaceutical Applications

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers