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usp-151-evaluation-of-skin-irritation-for-topical-dosage-forms
Dermatological & Sensitivity Testing AFNOR BP X30-221 In Vivo Human Skin Testing ProceduresASTM D2979 Assessment of Skin Sensitization PotentialASTM D4236 Labeling of Cosmetic Products for Skin SafetyASTM D6125 Evaluation of Skin Sensitization Using In Vitro ModelsASTM D6977 Evaluation of Skin Contact AllergensASTM E1490 Evaluation of Allergic Contact DermatitisASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended ProtocolASTM E2753 Human Repeat Insult Patch Test (HRIPT)ASTM F2312 Evaluation of Patch Test Allergen ReleaseCOLIPA Guidelines for Skin Compatibility TestingEN 16820 Test Method for Skin Sensitization PotentialEN 1811 Determination of Nickel Release from Skin-Contact ProductsEN ISO 10993-10 Assessment of Skin IrritationEN ISO 10993-18 Chemical Characterization for Dermal SafetyEN ISO 10993-21 Evaluation of Skin Irritation from Medical Device ExtractsEN ISO 10993-5 Cytotoxicity Testing on Skin CellsEP 5.1.6 Evaluation of Dermatological Safety of CosmeticsFDA 21 CFR 820 Quality System Regulation for Dermal DevicesFDA 21 CFR Part 807 Sensitivity Testing of Topical ProductsFDA Guidance for Dermatological Testing of Topical ProductsFDA Guidance on Dermal Sensitization Risk AssessmentISO 105-A02 Colorfastness to Artificial Light on SkinISO 10993-1 Biological Evaluation of Medical Devices - Dermal AspectsISO 10993-10 Evaluation of Skin Irritation and SensitizationISO 10993-11 Toxicity Testing Related to Skin ContactISO 10993-12 Sample Preparation for Dermal TestingISO 10993-16 Toxicokinetic Testing of Substances in Dermal ExposureISO 10993-17 Toxicological Risk Assessment for Dermal ProductsISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 10993-20 Dermal Toxicology Testing MethodsISO 10993-22 Evaluation of Sensitization from Skin Contact DevicesISO 10993-23 Evaluation of Phototoxicity and PhotoallergyISO 11137 Sterilization Validation of Dermal DevicesISO 11930 Preservative Effectiveness for Sensitive Skin ProductsISO 14155 Clinical Investigation of Medical Devices on SkinISO 15223-1 Symbols for Dermal Medical DevicesISO 15223-1 Symbols for Indicating Skin Contact in Medical DevicesISO 16128 Guidelines on Natural and Organic Cosmetic IngredientsISO 16128-1 Guidelines on Natural and Organic Cosmetics Part 1ISO 16128-2 Calculation of Natural Ingredient Content in Skin ProductsISO 16128-3 Methodologies for Determining Organic Content in Skin CareISO 16134 Human Repeat Insult Patch Test GuidanceISO 16134-2 Guidance for Patch Test Interpretation in Skin TestingISO 17516 Microbiological Limits for Skin ProductsISO 21404 Testing for Skin Contact AllergensISO 21486 Risk Assessment for Skin Contact MaterialsISO 22444 Measurement of Skin Moisture ContentISO 22715 Labeling Requirements for Skin and Cosmetic ProductsISO 22716 Good Manufacturing Practices for Dermatological ProductsISO 22716-1 Good Manufacturing Practices for Skin Care ProductsISO 23975 Patch Test Protocols for Dermatological ProductsISO 24441 In Vitro Determination of Sun Protection Factor (SPF)ISO 24442 Evaluation of Human Skin Irritation PotentialISO 24443 In Vitro Assessment of Sunscreen Efficacy on SkinISO 24443 In Vitro SPF Testing for SunscreensISO 24443 In Vitro UV Protection Factor Testing for SunscreensISO 24443 UV Protection Testing for Sensitive Skin FormulationsISO 3160-2 Compression Testing on Skin Contact MaterialsISO 3175-4 Analysis of Volatile Components Affecting Skin SensitivityISO 8124-6 Safety Requirements for Toys Affecting SkinISO/TR 16181 Guidelines on Skin Compatibility of CosmeticsISO/TR 16271 Guidelines on Safety Assessment for Skin Contact MaterialsISO/TR 19218 Dermatological Safety Data ManagementISO/TR 19930 Development of Dermal Sensitization AssaysISO/TR 22219 Testing of Skin Barrier FunctionISO/TR 29622 Allergens in Cosmetics and Personal Care ProductsJIS K 5600-5-7 Patch Test Methods for Skin SensitivityOECD TG 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization in AnimalsOECD TG 406 Skin Sensitization Testing in AnimalsOECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin SafetyOECD TG 439 In Vitro Skin Irritation Testing for CosmeticsOECD TG 442B Local Lymph Node Assay for Skin SensitizationOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens™)OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin SensitizationOECD TG 442E In Vitro Skin Sensitization Assay (h-CLAT)USP <151> Skin Sensitization Studies in Pharmaceuticals

USP <151> Evaluation of Skin Irritation for Topical Dosage Forms: Laboratory Testing Services

The USP <151> Evaluation of Skin Irritation for Topical Dosage Forms is a laboratory testing service that evaluates the potential skin irritation caused by topical dosage forms. This test is governed by various international and national standards, including ISO 10993-10:2013, ASTM E2047-15, EN 13726:2015, and TSE 1438.

Relevant Standards

  • ISO 10993-10:2013: Biological evaluation of medical devices Part 10: Tests for irritation and sensitization.

  • ASTM E2047-15: Standard Test Method for In Vitro Assessment of Skin Irritation Potential.

  • EN 13726:2015: Safety assessment for medical devices involving the use of biological systems.

  • TSE 1438: Turkish Standards Institution standard for the evaluation of skin irritation.

    • Standard Development Organizations and their Role

    Standard development organizations play a crucial role in establishing and maintaining standards. These organizations include:

  • ISO (International Organization for Standardization): Develops international standards.

  • ASTM (American Society for Testing and Materials): Develops American standards.

  • EN (European Committee for Electrotechnical Standardization): Develops European standards.

  • TSE (Turkish Standards Institution): Develops Turkish standards.

    • Standard Compliance Requirements

    The compliance requirements for different industries vary depending on the specific standard. For example:

  • Medical devices: Comply with ISO 10993-10:2013, ASTM E2047-15, and EN 13726:2015.

  • Cosmetics: Comply with EU Cosmetics Regulation (EC) No 1223/2009.

    • Standard Evolution and Updates

    Standards evolve and get updated to reflect changes in technology, science, and regulations. Eurolab stays up-to-date with the latest standards and ensures that our testing services comply with the most recent versions.

    Business and Technical Reasons for Conducting USP <151> Evaluation of Skin Irritation for Topical Dosage Forms Testing

    Conducting USP <151> Evaluation of Skin Irritation for Topical Dosage Forms testing is essential for ensuring product safety and reliability. This test helps to:

  • Identify potential skin irritation caused by topical dosage forms.

  • Ensure compliance with regulatory requirements.

  • Improve product quality and performance.

  • Enhance customer confidence and trust.

    • Consequences of Not Performing this Test

    Failing to conduct USP <151> Evaluation of Skin Irritation for Topical Dosage Forms testing can lead to:

  • Product recalls and withdrawals.

  • Regulatory fines and penalties.

  • Damage to brand reputation and loss of customer trust.

  • Financial losses due to product failure.

    • Industries and Sectors that Require this Testing

    The following industries and sectors require USP <151> Evaluation of Skin Irritation for Topical Dosage Forms testing:

  • Pharmaceuticals: Ensure safety and efficacy of topical dosage forms.

  • Cosmetics: Comply with EU Cosmetics Regulation (EC) No 1223/2009.

  • Personal care products: Ensure product safety and reliability.

    • Risk Factors and Safety Implications

    Conducting USP <151> Evaluation of Skin Irritation for Topical Dosage Forms testing helps to identify potential risk factors and safety implications, including:

  • Skin irritation and sensitization.

  • Allergic reactions and adverse events.

  • Product failure and recalls.

    • Quality Assurance and Quality Control Aspects

    Eurolab ensures that our USP <151> Evaluation of Skin Irritation for Topical Dosage Forms testing services meet the highest quality standards. Our quality control measures include:

  • Calibration and validation of testing equipment.

  • Sample preparation and handling procedures.

  • Data collection and recording procedures.

    • Competitive Advantages of Having this Testing Performed

    Conducting USP <151> Evaluation of Skin Irritation for Topical Dosage Forms testing provides competitive advantages, including:

  • Improved product quality and performance.

  • Enhanced customer confidence and trust.

  • Regulatory compliance and reduced risk.

    • Cost-Benefit Analysis of Performing this Test

    The cost-benefit analysis of conducting USP <151> Evaluation of Skin Irritation for Topical Dosage Forms testing is clear. The benefits far outweigh the costs, including:

  • Reduced product recalls and withdrawals.

  • Improved brand reputation and customer trust.

  • Financial savings due to reduced regulatory fines and penalties.

    • The USP <151> Evaluation of Skin Irritation for Topical Dosage Forms testing involves the following steps:

    1. Sample preparation: Prepare test samples according to ISO 10993-10:2013.

    2. Skin irritation testing: Conduct skin irritation testing using ASTM E2047-15.

    3. Data analysis: Analyze data and determine skin irritation potential.

    Sample Preparation

    Prepare test samples according to ISO 10993-10:2013, which includes:

  • Solvent selection.

  • Sample concentration.

  • Storage and handling procedures.

    • Skin Irritation Testing

    Conduct skin irritation testing using ASTM E2047-15, which involves:

  • In vitro assessment of skin irritation potential.

  • Evaluation of cytotoxicity and membrane damage.

    • Data Analysis

    Analyze data and determine skin irritation potential. This includes:

  • Calculation of EC50 (concentration causing 50 cell death).

  • Determination of skin irritation index.

    • Test Equipment and Reagents

    Use calibrated testing equipment and reagents, including:

  • Automated patch testing systems.

  • Skin irritation testing chambers.

    • Personnel Training and Experience

    Ensure that personnel are trained and experienced in conducting USP <151> Evaluation of Skin Irritation for Topical Dosage Forms testing. This includes:

  • Training on standard operating procedures.

  • Familiarization with testing equipment and reagents.

    • Test Validation and Calibration

    Validate and calibrate testing equipment regularly, including:

  • Verification of calibration dates.

  • Maintenance of testing equipment.

    • Data Management and Reporting

    Manage data and prepare reports according to regulatory requirements, including:

  • Data collection and recording procedures.

  • Report submission and approval.

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

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