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usp-1058-analytical-instrument-qualification-for-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 <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

USP <1058> Analytical Instrument Qualification for Leachables Testing: A Comprehensive Guide to Eurolabs Expertise

Standard-Related Information

The USP <1058> Analytical Instrument Qualification for Leachables Testing is a critical testing service required by the pharmaceutical and medical device industries. This standard, issued by the United States Pharmacopeia (USP), outlines the requirements for analytical instrument qualification to ensure the accuracy and reliability of leachables testing results.

ISO, ASTM, EN, TSE, and Other Relevant Standards

The USP <1058> standard is based on various international and national standards, including:

  • ISO 11135:2009 (Sterilization of medical instruments using an ethylene oxide sterilizer)

  • ASTM E2754-08 (Standard Practice for Qualification of Analytical Equipment)

  • EN 45011:1997 (General criteria for the selection of sampling points in process and quality control)

  • TSE 150 (Turkish Standards Institution) for analytical instrument qualification

    • These standards ensure that leachables testing results are accurate, reliable, and compliant with regulatory requirements.

    Standard Development Organizations

    The development and revision of standards involve various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations work together to ensure that standards are up-to-date and reflect the latest technological advancements.

    Evolution of Standards

    Standards evolve over time as new technologies emerge, and regulatory requirements change. The USP <1058> standard has undergone several revisions since its initial publication in 2010, with the most recent update released in 2022.

    Standard Numbers and Scope

    The relevant standards for leachables testing are:

  • ISO 11135:2009 (Sterilization of medical instruments using an ethylene oxide sterilizer)

  • ASTM E2754-08 (Standard Practice for Qualification of Analytical Equipment)

  • EN 45011:1997 (General criteria for the selection of sampling points in process and quality control)

    • These standards cover various aspects of analytical instrument qualification, including equipment selection, installation, operation, maintenance, and calibration.

    Compliance Requirements

    Industry-specific compliance requirements vary depending on the country and region. For example:

  • In the United States, USP <1058> is a mandatory requirement for pharmaceutical and medical device manufacturers.

  • In Europe, ISO 11135:2009 is a harmonized standard for sterilization of medical instruments using ethylene oxide.

    • Standard Compliance Requirements for Different Industries

    Industry-specific compliance requirements include:

  • Pharmaceutical industry: USP <1058> (Analytical Instrument Qualification for Leachables Testing)

  • Medical device industry: ISO 11135:2009 (Sterilization of medical instruments using an ethylene oxide sterilizer)

  • Food industry: FDA regulations on analytical instrument qualification

    • Standard Requirements and Needs

    Leachables testing is a critical aspect of pharmaceutical and medical device manufacturing, ensuring the safety and efficacy of products. The consequences of not performing leachables testing include:

  • Inaccurate or unreliable test results

  • Non-compliance with regulatory requirements

  • Potential health risks to patients

    • Business and Technical Reasons for Conducting USP <1058> Analytical Instrument Qualification for Leachables Testing

    Conducting USP <1058> analytical instrument qualification for leachables testing is essential for:

  • Ensuring the accuracy and reliability of test results

  • Complying with regulatory requirements

  • Mitigating potential health risks to patients

    • Industries and Sectors that Require this Testing

    Pharmaceutical and medical device industries require leachables testing to ensure product safety and efficacy.

    Risk Factors and Safety Implications

    Non-compliance with USP <1058> analytical instrument qualification for leachables testing can lead to:

  • Inaccurate or unreliable test results

  • Non-compliance with regulatory requirements

  • Potential health risks to patients

    • Quality Assurance and Quality Control Aspects

    Eurolabs quality management system ensures that all testing services, including USP <1058> analytical instrument qualification for leachables testing, meet the highest standards of accuracy and reliability.

    Competitive Advantages and Market Positioning

    Conducting USP <1058> analytical instrument qualification for leachables testing demonstrates a commitment to quality and regulatory compliance, enhancing market positioning and customer confidence.

    Cost-Benefit Analysis

    While the cost of conducting USP <1058> analytical instrument qualification for leachables testing may be significant, the benefits far outweigh the costs:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Mitigating potential health risks to patients

    • Test Conditions and Methodology

    The test is conducted according to the USP <1058> standard, which includes the following steps:

    1. Equipment selection and installation

    2. Operation and maintenance of equipment

    3. Calibration and validation of equipment

    4. Performance testing and qualification of equipment

    Eurolabs experienced team follows a strict quality control process to ensure that all testing services meet the highest standards.

    Conclusion

    USP <1058> analytical instrument qualification for leachables testing is a critical aspect of pharmaceutical and medical device manufacturing, ensuring product safety and efficacy. Eurolabs expertise in this area ensures compliance with regulatory requirements and mitigates potential health risks to patients.

    We hope that this comprehensive guide has provided valuable insights into the importance of USP <1058> analytical instrument qualification for leachables testing. If you have any questions or require further information, please do not hesitate to contact us.

    Eurolabs Expertise in USP <1058> Analytical Instrument Qualification for Leachables Testing

    At Eurolab, we pride ourselves on our expertise in USP <1058> analytical instrument qualification for leachables testing. Our team of experienced professionals follows a strict quality control process to ensure that all testing services meet the highest standards.

    Our laboratory is equipped with state-of-the-art equipment and technology, ensuring accurate and reliable test results. We work closely with clients to understand their specific needs and provide customized solutions.

    Get in Touch with Us

    If you require USP <1058> analytical instrument qualification for leachables testing services or have any questions about our expertise, please do not hesitate to contact us:

    Email: infoeurolab.com(mailto:infoeurolab.com)

    Phone: 1 (800) 123-4567

    Address: Eurolab Inc., 123 Main St, Anytown, USA

    We look forward to working with you.

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

    CONTACT US +902127020000

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