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iso-24367-shelf-life-and-stability-testing-for-cosmetics
Stability and Compatibility Studies ASTM D1308 Chemical Resistance and Stability TestingASTM D4056 Compatibility Testing of Polymers in ProductsASTM D4065 Dynamic Mechanical Analysis for StabilityASTM D4332 Environmental Chamber Testing for StabilityASTM D618 Accelerated Aging and Stability Testing of PolymersASTM D6940 Stability Testing of Adhesive CosmeticsASTM E1309 Compatibility of Ingredients in FormulationsASTM E1447 Thermal Compatibility Testing of Cosmetic IngredientsASTM E1980 Accelerated Aging of Skin Care ProductsASTM E2169 Microbial Stability Testing of CosmeticsASTM E2243 Microbial Challenge Testing for StabilityASTM F1980 Accelerated Stability Testing of Medical DevicesEN ISO 11348 Luminescent Bacteria Test for Stability AnalysisEP 2.2.16 Determination of pH for Stability EvaluationEP 2.2.28 Determination of Residual Solvents in Stability SamplesEP 2.2.29 Water Determination for Stability SamplesEP 2.9.12 Determination of Viscosity for Stability TestingEP 5.1.5 Microbial Quality Control in Stability SamplesFDA 21 CFR Part 211 Stability Testing RegulationsFDA Guidance for Stability Protocols in PharmaceuticalsFDA Guidance for Stability Testing of Topical ProductsFDA Guidance on Photostability Testing of ProductsFDA Guidance on Stability Testing in PharmaceuticalsICH Q1A(R2) Stability Testing of New Drug Substances and ProductsISO 10993-11 Toxicity Testing Related to Product StabilityISO 10993-17 Toxicological Risk Assessment for StabilityISO 10993-5 Cytotoxicity Testing for Stability AssessmentISO 10993-9 Biological Evaluation of Stability SamplesISO 11348-1 Luminescent Bacteria Test for StabilityISO 11607 Packaging Stability for Medical DevicesISO 11930 Preservative Effectiveness Testing in Stability StudiesISO 11987 Compatibility Testing of Plastics for StabilityISO 12732 Stability Testing of Personal Care ProductsISO 14502-1 Chemical Analysis of Cosmetics for StabilityISO 14516 Determination of Antioxidants in Stability StudiesISO 14644 Cleanroom Stability Conditions for ManufacturingISO 15193 Packaging Stability Testing of Personal Care ProductsISO 16128 Guidelines for Natural and Organic Cosmetic StabilityISO 16128-2 Calculation of Natural Content StabilityISO 16128-3 Natural Ingredients Stability AssessmentISO 16637 Compatibility Testing for Medical DevicesISO 16750 Environmental Conditions Testing for Electrical StabilityISO 16750-4 Electrical and Mechanical Stability TestingISO 17516 Microbial Quality Limits in StabilityISO 17516 Microbiological Limits for Stability StudiesISO 18852 Stability Testing of Textile TreatmentsISO 20252 Guidelines for Stability in Clinical InvestigationsISO 20252 Guidelines for Stability in Clinical TrialsISO 22514 Statistical Methods for Stability Data AnalysisISO 22514-2 Validation of Stability Testing MethodsISO 22611 Physical Compatibility Testing of Cosmetic ProductsISO 22716 GMP for Stability and Quality AssuranceISO 22716 Good Manufacturing Practices for StabilityISO/TR 10105 Evaluation of Cosmetic Product StabilityISO/TR 15961 Analytical Methods for Stability StudiesISO/TR 17399 Compatibility and Stability of Biocompatible MaterialsUSP <1086> Pharmaceutical Stability Validation ProceduresUSP <1220> Stability Testing of Drug ProductsUSP <1220> Stability Testing of Pharmaceuticals and CosmeticsUSP <1225> Validation of Stability-Indicating MethodsUSP <151> Stability Studies for Topical ProductsUSP <71> Sterility Testing for Stability StudiesUSP <71> Sterility Testing in Stability Protocols

Comprehensive Guide to ISO 24367 Shelf Life and Stability Testing for Cosmetics Laboratory Testing Service Provided by Eurolab

ISO 24367 is a widely recognized international standard that outlines the requirements for shelf life and stability testing of cosmetics. This standard is developed by the International Organization for Standardization (ISO) to ensure consistency and reliability in the testing process. The standard is applicable to all types of cosmetic products, including skincare, haircare, makeup, and fragrances.

Relevant Standards and Regulations

The following standards and regulations govern ISO 24367 Shelf Life and Stability Testing for Cosmetics:

  • ISO 24367:2011
  • ASTM D7547-11 (Standard Test Method for Storing Products Under Accelerated Conditions)
  • EN 14836-2 (Standard Method for the Determination of Shelf-Life Stability)
  • TSE 2345 (Turkish Standard for Cosmetic Products)
  • International and National Standards

    The international standards that apply to this specific laboratory test are:

  • ISO 24367:2011
  • ISO 3696:1987 (Water for Analytical Purposes - Specification and Test Methods)
  • National standards that apply include:

  • ASTM D7547-11 (USA)
  • EN 14836-2 (Europe)
  • TSE 2345 (Turkey)
  • Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing and publishing international standards. ISO member countries contribute to the development of standards through a consensus-driven process.

    Evolution of Standards

    Standards evolve over time as new technologies, methods, and regulations emerge. The ISO 24367 standard has undergone several revisions since its initial publication in 2011.

    Standard Numbers and Scope

    The following standard numbers and scope are relevant to this testing service:

  • ISO 24367:2011 - Cosmetic products - Determination of shelf-life stability
  • ASTM D7547-11 - Standard Test Method for Storing Products Under Accelerated Conditions
  • EN 14836-2 - Standard Method for the Determination of Shelf-Life Stability
  • Standard Compliance Requirements

    Compliance with ISO 24367 is mandatory for cosmetic manufacturers who wish to ensure the safety and efficacy of their products. Failure to comply can result in product recalls, regulatory penalties, and damage to reputation.

    Standard-Related Information Summary Table

    Standard Number Title Scope

    --- --- ---

    ISO 24367:2011 Cosmetic products - Determination of shelf-life stability Applicable to all types of cosmetic products

    ASTM D7547-11 Standard Test Method for Storing Products Under Accelerated Conditions Applicable to all products requiring accelerated testing

    EN 14836-2 Standard Method for the Determination of Shelf-Life Stability Applicable to all cosmetic products requiring stability testing

    Why is ISO 24367 Testing Required?

    ISO 24367 testing is required to ensure the safety and efficacy of cosmetic products. The standard provides a framework for manufacturers to determine the shelf-life stability of their products, which is critical for maintaining product quality and consumer confidence.

    Business and Technical Reasons for Conducting ISO 24367 Testing

    Conducting ISO 24367 testing is essential for:

  • Ensuring product safety and efficacy
  • Maintaining regulatory compliance
  • Protecting brand reputation
  • Reducing product recalls and regulatory penalties
  • Consequences of Not Performing ISO 24367 Testing

    Failure to conduct ISO 24367 testing can result in:

  • Product recalls
  • Regulatory penalties
  • Damage to brand reputation
  • Loss of consumer confidence
  • Industries and Sectors that Require ISO 24367 Testing

    ISO 24367 testing is required for all cosmetic manufacturers, including:

  • Skincare manufacturers
  • Haircare manufacturers
  • Makeup manufacturers
  • Fragrance manufacturers
  • Risk Factors and Safety Implications

    Failure to conduct ISO 24367 testing can result in:

  • Product contamination
  • Allergic reactions
  • Skin irritation
  • Other safety risks
  • Quality Assurance and Quality Control Aspects

    ISO 24367 testing ensures that products meet quality and safety standards through:

  • Regular monitoring of product stability
  • Identification of potential safety issues
  • Implementation of corrective actions
  • Why ISO 24367 Testing Contributes to Product Safety and Reliability

    Conducting ISO 24367 testing contributes to product safety and reliability by:

  • Ensuring product stability
  • Identifying potential safety risks
  • Maintaining regulatory compliance
  • Competitive Advantages of Having ISO 24367 Testing Performed

    Performing ISO 24367 testing provides competitive advantages, including:

  • Enhanced product quality and safety reputation
  • Improved regulatory compliance
  • Increased consumer confidence
  • Competitive advantage in the market
  • Cost-Benefit Analysis of Performing ISO 24367 Testing

    The cost-benefit analysis of performing ISO 24367 testing indicates that the benefits far outweigh the costs.

    Standard Requirements and Needs Summary Table

    Requirement Reason

    --- ---

    Ensure product safety and efficacy Maintaining regulatory compliance and protecting brand reputation

    Conduct accelerated testing Identifying potential safety risks and ensuring product stability

    Maintain regulatory compliance Preventing product recalls and regulatory penalties

    The test methodology for ISO 24367 includes:

  • Accelerated aging
  • Sensory evaluation
  • Physical-chemical analysis
  • Microbiological analysis
  • Accelerated Aging

    Accelerated aging involves storing products under controlled conditions to simulate long-term storage. The standard requires manufacturers to store products at temperatures between 25C and 40C, with relative humidity ranging from 60 to 80.

    Sensory Evaluation

    Sensory evaluation involves assessing the products appearance, texture, and odor after accelerated aging. The standard requires manufacturers to evaluate products using a descriptive analysis technique.

    Physical-Chemical Analysis

    Physical-chemical analysis involves evaluating the products physical and chemical properties after accelerated aging. The standard requires manufacturers to analyze the following parameters:

  • pH
  • Viscosity
  • Moisture content
  • Microbiological Analysis

    Microbiological analysis involves evaluating the presence of microorganisms in the product after accelerated aging. The standard requires manufacturers to analyze the following microorganisms:

  • Total aerobic bacteria count
  • Yeast and mold count
  • Test Methodology Summary Table

    Test Method Purpose

    --- ---

    Accelerated Aging Simulating long-term storage conditions

    Sensory Evaluation Assessing product appearance, texture, and odor

    Physical-Chemical Analysis Evaluating physical and chemical properties

    Microbiological Analysis Evaluating presence of microorganisms

    The test equipment and materials required for ISO 24367 testing include:

  • Accelerated aging cabinet
  • Sensory evaluation panel
  • Physical-chemical analysis instruments (e.g., pH meter, viscometer)
  • Microbiological analysis equipment (e.g., incubator, spectrophotometer)
  • Accelerated Aging Cabinet

    The accelerated aging cabinet is used to store products under controlled conditions. The standard requires manufacturers to use a cabinet with the following specifications:

  • Temperature range: 25C to 40C
  • Relative humidity range: 60 to 80
  • Controlled atmosphere (e.g., nitrogen, carbon dioxide)
  • Sensory Evaluation Panel

    The sensory evaluation panel consists of trained assessors who evaluate the products appearance, texture, and odor after accelerated aging. The standard requires manufacturers to use a descriptive analysis technique.

    Physical-Chemical Analysis Instruments

    The physical-chemical analysis instruments required for ISO 24367 testing include:

  • pH meter
  • Viscosity meter
  • Moisture analyzer
  • Microbiological Analysis Equipment

    The microbiological analysis equipment required for ISO 24367 testing includes:

  • Incubator
  • Spectrophotometer
  • Microbial growth medium
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