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usp-87-biological-reactivity-test-in-vitro-cytotoxicity
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 <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 <87> Biological Reactivity Test: In Vitro Cytotoxicity Laboratory Testing Service

Provided by Eurolab - A Comprehensive Guide to Understanding the Importance of this Critical Testing Service

The USP <87> Biological Reactivity Test: In Vitro Cytotoxicity is a laboratory testing service that evaluates the potential cytotoxic effects of materials on living cells. This test is governed by various international and national standards, including:

  • ISO 10993-5:2009 - Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

  • ASTM F748-04 (2016) - Standard Practice for Selecting, Testing, and Specifying Materials for Medical Applications

  • EN ISO 10993-5:2009 - Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

  • TSE (Turkish Standards Institution) L1167:2014 - Biyolojik Değerlendirmeye İlişkin Standard

    • These standards outline the requirements and procedures for conducting the USP <87> Biological Reactivity Test: In Vitro Cytotoxicity, including the selection of test materials, cell lines, and testing conditions.

    The legal and regulatory framework surrounding this testing service is primarily governed by the regulations and guidelines set forth by the U.S. Food and Drug Administration (FDA), the European Unions Medical Device Regulation (MDR), and other national regulatory agencies. These regulations mandate that medical devices and materials be evaluated for their potential cytotoxic effects before being marketed or used in humans.

    International standardization organizations, such as ISO and ASTM, play a crucial role in developing and maintaining standards for laboratory testing services like the USP <87> Biological Reactivity Test: In Vitro Cytotoxicity. These organizations ensure that standards are updated regularly to reflect advances in technology and scientific knowledge.

    The USP <87> Biological Reactivity Test: In Vitro Cytotoxicity is a critical testing service required by various industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Cosmetics and personal care product manufacturers

  • Dental and orthopedic implant manufacturers

    • Conducting this test is essential to ensure the safety and efficacy of medical devices, materials, and products that come into contact with living tissues. The consequences of not performing this test can be severe, including:

  • Product recalls and withdrawals from the market

  • Liability claims and lawsuits against companies

  • Loss of regulatory approvals and licenses

  • Damage to company reputation and brand image

    • The USP <87> Biological Reactivity Test: In Vitro Cytotoxicity contributes significantly to product safety and reliability by identifying potential cytotoxic effects and allowing manufacturers to take corrective actions. This testing also helps companies comply with regulatory requirements, reducing the risk of non-compliance and associated consequences.

    In addition to ensuring product safety, this testing service provides several competitive advantages, including:

  • Enhanced product quality and reputation

  • Improved customer confidence and trust

  • Increased market access and trade facilitation

  • Innovation and research development support

    • The USP <87> Biological Reactivity Test: In Vitro Cytotoxicity involves several steps, including:

    1. Sample Preparation: The test material is prepared according to the standard requirements, including weighing, grinding, or dissolving.

    2. Cell Line Selection: A suitable cell line is selected for the test, typically a fibroblast or epithelial cell line.

    3. Testing Conditions: The test material is exposed to the cell line under controlled conditions, including temperature, humidity, and pH.

    4. Measurement and Analysis: Cell viability and cytotoxicity are measured using various techniques, such as MTT assay, LDH release, or fluorescence microscopy.

    The testing equipment and instruments used for this service include:

  • Microplate readers

  • Spectrophotometers

  • Fluorescence microscopes

  • Temperature and humidity control units

    • The sample preparation procedures involve careful handling of the test material to ensure accurate representation of its cytotoxic effects. The testing parameters and conditions are strictly controlled according to the standard requirements.

    The test results are documented and reported in a clear and concise manner, including:

  • Test method used

  • Sample preparation details

  • Testing conditions

  • Results and interpretation

  • Conclusion and recommendations

    • The report format and structure follow the standard requirements outlined by ISO 10993-5:2009. The certification and accreditation aspects of this service are maintained through regular audits and inspections by national and international regulatory agencies.

    Conducting the USP <87> Biological Reactivity Test: In Vitro Cytotoxicity provides numerous benefits, including:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Enhancing product quality and reputation

  • Improving customer confidence and trust

  • Increasing market access and trade facilitation

    • This testing service is essential for companies that manufacture medical devices, materials, or products that come into contact with living tissues. By performing this test, manufacturers can identify potential cytotoxic effects and take corrective actions to ensure the safety of their products.

    Conclusion

    The USP <87> Biological Reactivity Test: In Vitro Cytotoxicity is a critical laboratory testing service required by various industries. Conducting this test ensures product safety and efficacy, compliance with regulatory requirements, and enhances company reputation and market access. Eurolab provides this service according to the standard requirements outlined by international and national standards, ensuring accurate and reliable results.

    About Eurolab

    Eurolab is a leading provider of laboratory testing services, including the USP <87> Biological Reactivity Test: In Vitro Cytotoxicity. With a team of experienced professionals and state-of-the-art equipment, we ensure that our clients receive high-quality results that meet their needs.

    If you have any questions or would like to learn more about this service, please do not hesitate to contact us.

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

    CONTACT US +902127020000

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