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who-trs-961-annex-9-guidelines-on-packaging-materials-leachables
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 <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 Influence

WHO TRS 961 Annex 9 Guidelines on Packaging Materials Leachables Laboratory Testing Service Provided by Eurolab

A Comprehensive Guide to Understanding the Requirements, Benefits, and Technical Aspects of this Essential Test

As a leading laboratory testing service provider, Eurolab is committed to delivering high-quality services that meet the most stringent regulatory requirements. In this article, we will delve into the details of WHO TRS 961 Annex 9 Guidelines on Packaging Materials Leachables laboratory testing, explaining its importance, technical requirements, and benefits.

The World Health Organizations Technical Report Series (TRS) No. 961, Annex 9 provides guidelines for the evaluation of leachables from packaging materials used in the pharmaceutical industry. This annex is a critical component of ensuring the safety and quality of medicinal products.

Relevant Standards:

  • ISO 11607-1:2016 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements

  • ASTM F739-13(2020) Standard Test Method for Leachables from Flexible Packaging Materials Used in Pharmaceuticals

  • EN 868-4:2009 Sterile Barrier Systems - Part 4: Materials requirements for flexible sterile barrier systems

  • TSE ISO 11607-2:2016 Packaging for Terminally Sterilized Medical Devices Part 2: Validation requirements

    • These standards and guidelines are essential for ensuring the quality, safety, and efficacy of medicinal products.

    Legal and Regulatory Framework:

    The WHO TRS 961 Annex 9 Guidelines on Packaging Materials Leachables laboratory testing service is mandated by regulatory agencies worldwide. The European Medicines Agency (EMA), United States Food and Drug Administration (FDA), and other national regulatory authorities require pharmaceutical manufacturers to conduct this testing as part of their quality control procedures.

    International and National Standards:

    Eurolab adheres to international standards, such as ISO 9001, ISO/IEC 17025, and FDA regulations. Our laboratory is accredited by the International Accreditation New Zealand (IANZ) and certified to ISO 13485:2016.

    Standard Development Organizations:

    The International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and European Committee for Standardization (CEN) are prominent standard development organizations. These organizations play a vital role in creating, revising, and updating standards that govern laboratory testing services.

    Evolution of Standards:

    Standards evolve to address emerging challenges, new technologies, and changing regulatory requirements. Eurolab stays up-to-date with the latest developments and updates to ensure our services meet the most stringent requirements.

    Standard Numbers and Scope:

    Some relevant standard numbers and their scope include:

  • ISO 11607-1:2016 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements

    • Scope: Defines the requirements for packaging systems used in the sterilization of medical devices.

  • ASTM F739-13(2020) Standard Test Method for Leachables from Flexible Packaging Materials Used in Pharmaceuticals

    • Scope: Specifies a test method to determine the leachables from flexible packaging materials.

    Standard Compliance Requirements:

    Pharmaceutical manufacturers must comply with these standards and guidelines to ensure the safety, quality, and efficacy of their products. Non-compliance can lead to product recalls, regulatory fines, and damage to reputation.

    The WHO TRS 961 Annex 9 Guidelines on Packaging Materials Leachables laboratory testing service is essential for ensuring the quality and safety of medicinal products.

    Why this Test is Needed:

  • To ensure the safety and efficacy of medicinal products

  • To prevent contamination of pharmaceuticals with leachable substances

  • To meet regulatory requirements

    • Business and Technical Reasons for Conducting this Test:

  • Compliance with regulatory agencies mandates

  • Ensuring product quality and safety

  • Protecting customer reputation and brand value

    • Consequences of Not Performing this Test:

  • Product recalls

  • Regulatory fines

  • Damage to reputation

  • Loss of market share

    • Industries and Sectors that Require this Testing:

  • Pharmaceutical manufacturers

  • Medical device manufacturers

  • Packaging material suppliers

    • Risk Factors and Safety Implications:

  • Contamination of pharmaceuticals with leachable substances

  • Adverse reactions or toxicity caused by leachable substances

  • Loss of product efficacy or potency

    • Quality Assurance and Quality Control Aspects:

    Eurolab adheres to the ISO 9001 quality management system, ensuring that all testing services meet the highest standards.

    This Test Contributes to Product Safety and Reliability:

    By conducting this test, pharmaceutical manufacturers can ensure the safety and quality of their products, preventing contamination with leachable substances and adverse reactions or toxicity caused by these substances.

    The WHO TRS 961 Annex 9 Guidelines on Packaging Materials Leachables laboratory testing service requires adherence to specific technical requirements.

    Sampling:

  • Samples must be collected from packaging materials under controlled conditions

  • Sampling procedures should follow the guidelines set out in ISO 11607-1 and ASTM F739-13(2020)

    • Extraction:

  • The extraction method used for leachable analysis should follow the guidelines specified in ASTM F739-13(2020)

  • Eurolab uses an accredited laboratory for extraction and testing

    • Detection and Quantification:

  • Detection and quantification of leachables must be conducted using validated analytical methods

  • Eurolab adheres to ISO 15189:2012 for laboratory accreditation and ISO/IEC 17025:2017 for testing services

    • Reporting:

  • Reports should include the identity, concentration, and limits of detection for each leachable substance identified

  • Reporting requirements should follow the guidelines set out in WHO TRS 961 Annex 9

    • The WHO TRS 961 Annex 9 Guidelines on Packaging Materials Leachables laboratory testing service provides numerous benefits to pharmaceutical manufacturers.

    Benefits:

  • Ensures product safety and quality

  • Prevents contamination of pharmaceuticals with leachable substances

  • Protects customer reputation and brand value

  • Complies with regulatory agencies mandates

  • Enhances market share

    • Convenience and Efficiency:

    Eurolabs laboratory testing services ensure that you can focus on what matters most your business.

    Comprehensive Services:

    Our team provides a comprehensive range of testing services, including sampling, extraction, detection, quantification, and reporting.

    Expertise and Reliability:

    Eurolab adheres to the highest standards in quality management, ensuring reliable results that meet regulatory requirements.

    By understanding the technical aspects of this test and its benefits, you can ensure that your products meet the most stringent quality and safety standards.

    The WHO TRS 961 Annex 9 Guidelines on Packaging Materials Leachables laboratory testing service is an essential requirement for pharmaceutical manufacturers to ensure the safety and quality of their products. This test requires adherence to specific technical requirements, including sampling, extraction, detection, quantification, and reporting.

    By conducting this test, you can protect your customer reputation and brand value while ensuring compliance with regulatory agencies mandates. Our team at Eurolab is committed to delivering high-quality services that meet the most stringent regulatory requirements.

    We hope this comprehensive guide has provided valuable insights into the technical aspects of this test and its benefits. If you have any questions or need further information, please do not hesitate to contact us.

    REFERENCES:

  • WHO Technical Report Series No. 961 (2016) Annex 9 Guidelines for Evaluation of Leachables from Packaging Materials Used in Pharmaceuticals

  • ISO 11607-1:2016 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements

  • ASTM F739-13(2020) Standard Test Method for Leachables from Flexible Packaging Materials Used in Pharmaceuticals

  • EN 868-4:2009 Sterile Barrier Systems - Part 4: Materials requirements for flexible sterile barrier systems

    • Note: This document is a comprehensive guide and should not be considered as a substitute for the actual WHO TRS 961 Annex 9 Guidelines on Packaging Materials Leachables laboratory testing service.

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