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usp-800-hazardous-drug-handling-leachables-from-packaging
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 <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 <800> Hazardous Drug Handling Leachables from Packaging Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide to Ensuring Safe and Reliable Pharmaceutical Products

As the global demand for pharmaceutical products continues to rise, ensuring the safety and reliability of these products has become increasingly important. One critical aspect of this is the testing of leachables from packaging materials, as specified in USP <800> Hazardous Drug Handling Leachables from Packaging. In this comprehensive guide, Eurolab will walk you through the importance of this testing service, the standards and regulations that govern it, and how our state-of-the-art laboratory can provide expert support.

STANDARD-RELATED INFORMATION

USP <800> is a widely recognized standard for hazardous drug handling in healthcare settings. Leachables from packaging materials refer to substances that may leach into or be extracted from pharmaceutical products during storage, transportation, or use. These substances can pose serious health risks if not properly identified and controlled.

Some of the key standards related to USP <800> include:

  • ISO 14644-1:2015: General requirements for classification of airborne clean rooms.

  • ASTM E1058-12: Guide for Decontamination of Equipment, Materials, Surfaces, and Containers.

  • EN ISO 11609:2007: Cleanrooms and associated controlled environments Particles sizes and types.

    • International and national standards that apply to this specific laboratory test include:

  • USP <800>

  • EU GMP Annex 1

  • ICH Q3A (R2)

    • Standard development organizations play a crucial role in shaping the testing protocols for leachables from packaging materials. These organizations include:

  • US Pharmacopeia (USP): A non-profit organization that develops standards for pharmaceutical products and services.

  • International Organization for Standardization (ISO): An independent, non-governmental organization that promotes worldwide proprietary, industrial, and commercial standards.

    • Standards evolve over time to reflect advancements in technology and changes in regulatory requirements. The development of new standards involves:

    1. Identifying the need for a standard

    2. Gathering input from stakeholders

    3. Drafting the standard

    4. Reviewing and revising the standard

    5. Finalizing and publishing the standard

    STANDARD REQUIREMENTS AND NEEDS

    The testing of leachables from packaging materials is necessary to ensure the safety and reliability of pharmaceutical products. Failure to conduct this test can result in:

  • Non-compliance with regulations: Manufacturers may be subject to fines, penalties, or even product recalls.

  • Product contamination: Leachables can contaminate pharmaceutical products, leading to reduced efficacy or even harm to patients.

  • Damage to brand reputation: Non-compliance or product contamination can damage a manufacturers reputation and erode customer trust.

    • The industries that require this testing include:

  • Pharmaceuticals: Manufacturers of injectable drugs, vaccines, and other pharmaceutical products.

  • Biotechnology: Companies involved in the development and production of biologics.

  • Medical devices: Manufacturers of medical devices, including those used for injections or infusions.

    • The risk factors associated with leachables from packaging materials include:

  • Chemical contamination: Leachables can introduce chemicals into pharmaceutical products, which can harm patients or reduce product efficacy.

  • Biological contamination: Leachables can also introduce biological contaminants, such as bacteria or viruses, into pharmaceutical products.

    • Quality assurance and quality control measures are essential to ensure the accuracy and reliability of test results. These measures include:

  • Calibration and validation: Ensuring that testing equipment is properly calibrated and validated.

  • Sample preparation: Properly preparing samples for testing.

  • Measurement and analysis methods: Using accurate and reliable measurement and analysis methods.

    • TEST CONDITIONS AND METHODOLOGY

    The testing of leachables from packaging materials involves the following steps:

    1. Sampling: Collecting representative samples from packaging materials.

    2. Extraction: Extracting potential leachables from the sample using a suitable solvent or method.

    3. Analysis: Analyzing the extracted solution for the presence of leachables using techniques such as HPLC, GC-MS, or LC-MS/MS.

    The testing equipment and instruments used include:

  • HPLC systems

  • GC-MS systems

  • LC-MS/MS systems

    • The testing environment requirements include:

  • Temperature: Maintaining a controlled temperature (e.g., 25C) for testing.

  • Humidity: Controlling humidity levels to prevent degradation of samples or equipment.

    • TEST REPORTING AND DOCUMENTATION

    Test results are documented and reported in accordance with industry standards, including:

  • USP <800>

  • EU GMP Annex 1

  • ICH Q3A (R2)

    • The test report should include:

  • Summary of the testing method

  • Results: Including concentrations and limits of detection.

  • Conclusion: Based on the results, including any recommendations for further action.

    • CONCLUSION

    Ensuring the safety and reliability of pharmaceutical products requires thorough testing of leachables from packaging materials. By following industry standards and best practices, manufacturers can minimize risks associated with leachables and ensure compliance with regulations.

    At Eurolab, our team of experts is committed to providing high-quality laboratory services that meet the needs of the pharmaceutical industry. Contact us today to learn more about how we can support your testing requirements.

    About Us

    Eurolab is a leading provider of laboratory services for the pharmaceutical industry. Our state-of-the-art facility is equipped with the latest technology and staffed by highly trained experts in their field.

    We offer a range of laboratory services, including:

  • Chemical analysis

  • Biological testing

  • Microbiological testing

    • Our commitment to quality, safety, and compliance ensures that our customers receive accurate and reliable results.

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

    CONTACT US +902127020000

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