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usp-88-biological-reactivity-test-in-vivo-irritation-toxicity
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 <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

USP <88> Biological Reactivity Test: In Vivo Irritation Toxicity Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide to Ensuring Product Safety and Reliability

Standard-Related Information

The USP <88> Biological Reactivity Test: In Vivo Irritation Toxicity is a standardized laboratory test that evaluates the biological reactivity of materials, devices, or substances on living tissues. This test is governed by various international and national standards, including ISO 10993-11, ASTM F748, EN 30993-11, TSE K (Turkish Standards), and others.

International and National Standards

  • ISO 10993-11: Biological evaluation of medical devices Part 11: Tests for irritation

  • ASTM F748: Standard Practice for Selecting Generic Biological Test Data for Materials and Products

  • EN 30993-11: Biocompatibility test for non-critical contact lenses and other eye care products (Part 11)

  • TSE K: Turkish Standards Institution standards for biological evaluation of medical devices

    • Standard Development Organizations

    The development and maintenance of these standards are entrusted to various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve over time as new scientific evidence emerges, and new technologies are developed. Regular updates ensure that the standards remain relevant and effective in ensuring product safety and reliability.

    Scope and Application

    These standards apply to a wide range of industries, including medical devices, pharmaceuticals, cosmetics, and consumer products. Compliance with these standards is mandatory for companies operating within these sectors.

    Standard Compliance Requirements

    Different industries have varying compliance requirements. For example:

  • Medical devices must comply with ISO 10993-11

  • Pharmaceuticals must comply with ASTM F748

  • Cosmetics must comply with EN 30993-11

    • Consequences of Non-Compliance

    Non-compliance with these standards can result in product recalls, fines, and damage to a companys reputation.

    Standard Requirements and Needs

    The USP <88> Biological Reactivity Test: In Vivo Irritation Toxicity is essential for ensuring the safety and efficacy of products. This test evaluates the biological reactivity of materials on living tissues, providing critical information for product development and approval.

    Business and Technical Reasons

    Conducting this test provides several benefits:

  • Ensures product safety and reliability

  • Complies with regulatory requirements

  • Enhances customer confidence and trust

  • Supports innovation and research development

  • Contributes to environmental sustainability

    • Risk Factors and Safety Implications

    Biological reactivity testing identifies potential risks associated with product use, ensuring that products are safe for consumers.

    Quality Assurance and Quality Control Aspects

    This test is subject to rigorous quality assurance and control procedures, including calibration, validation, and measurement methods.

    Competitive Advantages

    Performing this test demonstrates a companys commitment to product safety, customer satisfaction, and regulatory compliance.

    Cost-Benefit Analysis

    Conducting the USP <88> Biological Reactivity Test: In Vivo Irritation Toxicity provides long-term cost savings and efficiency improvements by reducing the risk of product recalls, fines, and reputational damage.

    Test Conditions and Methodology

    The test is conducted in accordance with ISO 10993-11, ASTM F748, EN 30993-11, and TSE K. The testing environment requires specific conditions for temperature, humidity, pressure, and other parameters.

    Testing Equipment and Instruments

    Eurolab uses state-of-the-art equipment, including:

  • Incubators

  • Microscopes

  • Analyzers

    • Sample Preparation Procedures

    Samples are prepared according to the relevant standards, ensuring accurate and reliable results.

    Measurement and Analysis Methods

    Results are measured and analyzed using calibrated instruments and software, ensuring precise data collection.

    Calibration and Validation Procedures

    All equipment is regularly calibrated and validated to ensure accuracy and reliability.

    Quality Control Measures

    Eurolabs quality control measures include:

  • Regular audits

  • Calibration and validation of equipment

  • Measurement and analysis methods

    • Data Collection and Recording Procedures

    Results are collected, recorded, and documented according to the relevant standards.

    Testing Timeframes and Duration

    The testing duration varies depending on the product type and complexity.

    Sample Size Requirements and Statistical Considerations

    Sample size requirements and statistical considerations are determined based on the relevant standards.

    Test Reporting and Documentation

    Results are reported in a structured format, including:

  • Test summary

  • Results tables

  • Graphs and charts

    • Certification and Accreditation Aspects

    Eurolab is accredited by recognized accreditation bodies for this test.

    Traceability and Documentation Requirements

    All results are documented and traceable according to the relevant standards.

    Why Choose Eurolab?

    Eurolab offers a comprehensive testing service, ensuring accurate and reliable results. Our experienced team follows rigorous quality control procedures, guaranteeing compliance with regulatory requirements and industry standards.

    Conclusion

    The USP <88> Biological Reactivity Test: In Vivo Irritation Toxicity is an essential test for ensuring product safety and reliability. Eurolabs expertise and state-of-the-art facilities ensure accurate and reliable results, providing a competitive advantage in the market. By choosing Eurolab, companies can demonstrate their commitment to product safety, customer satisfaction, and regulatory compliance.

    References

    1. ISO 10993-11: Biological evaluation of medical devices Part 11: Tests for irritation

    2. ASTM F748: Standard Practice for Selecting Generic Biological Test Data for Materials and Products

    3. EN 30993-11: Biocompatibility test for non-critical contact lenses and other eye care products (Part 11)

    4. TSE K: Turkish Standards Institution standards for biological evaluation of medical devices

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