EUROLAB
isotr-24444-comparison-of-microbiological-test-protocols
Microbiological Quality Testing AFNOR NF T73-101 Microbial Preservation Testing for CosmeticsANSM Challenge Testing of Natural Cosmetic FormulasANSM Microbiological Control of Non-Sterile Cosmetic ProductsANVISA RDC 481/2021 Microbial Control for Brazilian Cosmetic ProductsAOAC 2003.07 Challenge Test for Cosmetic CreamsAOAC 991.14 Microbial Contamination Detection in Personal Care ProductsAOAC 997.02 Microbial Quality of ToiletriesASTM D4014 Test for Microbial Growth on Lotions and CreamsASTM D5338 Biodegradation and Microbial Interaction in CosmeticsASTM D7983 Testing for Bacterial Endotoxins in Eye-area CosmeticsASTM E1326 Viable Organism Testing in Aerosolized Cosmetic ProductsASTM E2180 Antimicrobial Efficacy Testing of Preservative SystemsASTM E2275 Skin Antiseptic Residual Activity TestingASTM E2315 Time-Kill Assessment of Antimicrobial ActivityASTM E2613 Microbial Analysis of Water Used in CosmeticsASTM E2786 Biofilm Formation in Cosmetic Production EnvironmentsASTM E640 Bacterial Filtration in Cosmetic SpraysASTM F2101 Bacterial Filtration Efficiency of Cosmetic Face MasksCEN/TR 16953 Guidance on Application of ISO Microbial StandardsChina GB 7919 Microbial Limits in Non-Sterile CosmeticsChina GB/T 13531.1 Detection of E. coli in CosmeticsChina GB/T 13531.2 Detection of Pathogenic Bacteria in CosmeticsChina GB/T 13531.3 Microbial Limit in Baby ProductsCOLIPA Guideline for Preservation Efficacy TestingCOLIPA Microbiological Quality Assurance of Cosmetic ProductsEP 2.6.1 Sterility Test for Cosmetic Raw MaterialsEP 2.6.12 Total Aerobic Microbial Count TestingEP 2.6.13 Detection of Designated Microorganisms in CosmeticsEP 2.6.31 Validation of Microbiological Test Methods for CosmeticsEP 5.1.3 Evaluation of Preservative EffectivenessEP 5.1.4 Microbial Limits in Raw Cosmetic IngredientsEPA MB-17 Microbial Contamination Control in Natural FormulasFDA 21 CFR 211.113 Contamination Prevention Procedures for CosmeticsFDA 21 CFR 700.3 Microbial Contamination Limits in CosmeticsFDA BAM Chapter 14 Yeast and Mold Enumeration in Personal Care ProductsFDA BAM Chapter 23 Detection of Bacterial Pathogens in CosmeticsFDA CFSAN Guidelines for Cosmetic Microbiological SamplingFDA CPG Sec. 7120.01 Microbiological Criteria for Finished CosmeticsHealth Canada Compendial Test for Pathogenic Organisms in CosmeticsHealth Canada Cosmetic Microbiological Contamination GuidelinesIndia IS 14642 Microbial Contamination in Toiletries and SkincareIndia IS 4707-2 Cosmetic Ingredients Microbial AssessmentISO 11930 Microbiological Preservation Efficacy TestingISO 11932 Method Validation for Microbial Testing in CosmeticsISO 11989 Microbial Assessment of Eye CosmeticsISO 14502-2 Microbiological Testing of Polyphenol-Rich CosmeticsISO 16212 Quantification of Yeasts and Molds in Cosmetic ProductsISO 17516 Quantitative Limits of Microorganisms in Finished ProductsISO 18415 Detection of Specified and Non-Specified MicroorganismsISO 19007 Preservation Test of Microbial Resistance in Cosmetic WipesISO 21148 Detection of Anaerobic Bacteria in Cosmetic FormulationsISO 21149 Detection of Aerobic Mesophilic Bacteria in CosmeticsISO 21150 Detection of Escherichia coli in CosmeticsISO 22176 Hygiene Requirements in Cosmetic Packaging LinesISO 22716 Microbial Risk Management in GMP Cosmetic ManufacturingISO 22717 Identification of Pseudomonas aeruginosa in Cosmetic ProductsISO 22718 Identification of Staphylococcus aureus in CosmeticsISO 22719 Detection of Candida albicans in Cosmetic ProductsISO 24434 Enumeration of Aerobic Mesophilic Spores in Personal CareISO 24442 Selection Criteria for Challenge Test OrganismsISO 29621 Microbiological Risk Assessment for Low-Risk ProductsISO/TR 19838 Guidance on Risk Management for Cosmetic MicrobiologyISO/TR 24475 Microbiological Assessment of Cosmetic Raw MaterialsISO/TR 24476 Test Method Selection for Cosmetic Product MicrobiologyISO/TS 29621 Categorization of Cosmetic Products Based on Microbiological RiskJIS K 5101 Preservative Efficiency in Japanese CosmeticsJIS L 1902 Evaluation of Antibacterial Activity of Cosmetic TextilesJIS Z 2801 Antimicrobial Efficacy Testing for Surfaces in Cosmetic FacilitiesKFDA Microbiological Safety Evaluation of Korean Cosmetic ProductsKFDA Testing for Microbial Contamination in Imported CosmeticsPh. Eur. 2.6.12 Total Count Test for EmulsionsPh. Eur. 2.6.13 Detection of Pathogens in Powdered CosmeticsSCCS/1564/15 Risk Assessment of Microbiological Contamination in CosmeticsSCCS/1611/19 Safety Levels of Microbial Contaminants in CosmeticsTS 13218 Total Bacteria Count in Cosmetic CreamsTS 13531 Bacterial Safety Testing of Shampoo ProductsTS EN 12353 Hygiene Control of Cosmetic Containers and ClosuresTS EN ISO 11930 Preservative Efficacy Test for Personal Care ProductsTS EN ISO 16212 Mold and Yeast Count in Cosmetic LiquidsTS EN ISO 18415 Detection of Transient Organisms in ToiletriesTS EN ISO 21148 Enumeration of Microorganisms in Cosmetic ProductsUSP <1227> Validation of Microbial Recovery in Cosmetic ProductsUSP <1231> Water Quality for Microbiological Control in Cosmetic ProductionUSP <2021> Microbial Control of Nutraceutical-Cosmetic HybridsUSP <2022> Evaluation of Cosmetic Quality Control ProtocolsUSP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test)USP <61> Microbial Enumeration Testing for Non-Sterile CosmeticsUSP <62> Testing for Specified Microorganisms in CosmeticsUSP <791> pH Control and Microbial Growth AssessmentWHO Guidelines for the Microbiological Control of Herbal Cosmetics

Complete Guide to ISO/TR 24444 Comparison of Microbiological Test Protocols Laboratory Testing Service

Provided by Eurolab

ISO/TR 24444 is a Technical Report that provides guidelines for comparing microbiological test protocols. This document is developed by the International Organization for Standardization (ISO) and is intended to help laboratories ensure consistency and comparability of their microbiological testing results.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO/TR 24444 is governed by various international and national standards, including:

  • ISO 17025:2018 General requirements for the competence of testing and calibration laboratories
  • ISO 22000:2018 Food safety management systems
  • EU Regulation (EC) No. 2023/2006 on animal health
  • These standards and regulations require laboratories to adhere to specific guidelines and protocols when conducting microbiological tests, including the use of standard methods, equipment, and personnel.

    International and National Standards

    The following international and national standards are relevant to ISO/TR 24444:

  • ISO 11133:2014 Microbiology -- General requirements for culture media
  • ISO 11290-1:1998 Microbiology -- Determination of the safety character of food and animal feeding stuffs -- Part 1: Horizontal method for detection of E. coli O157:H7, Salmonella spp., Listeria monocytogenes and Campylobacter spp.
  • EU Directive (EC) No. 2004/54 on the hygiene and public health requirements for fishery products
  • These standards provide specific guidelines for microbiological testing, including sampling, equipment, and analysis.

    Standard Development Organizations

    The standard development organizations involved in the creation of ISO/TR 24444 include:

  • International Organization for Standardization (ISO)
  • European Committee for Standardization (CEN)
  • American Society for Testing and Materials (ASTM)
  • These organizations work together to develop and maintain standards that ensure consistency and comparability across industries.

    Standard Evolution and Updates

    Standards are regularly reviewed and updated to reflect new research, technologies, and regulatory requirements. ISO/TR 24444 is no exception, with updates made in 2018 to reflect changes in microbiological testing methods and equipment.

    Specific Standard Numbers and Scope

    The following standard numbers and scope are relevant to ISO/TR 24444:

  • ISO/TR 24444:2018 Comparison of Microbiological Test Protocols
  • ISO 17025:2018 General requirements for the competence of testing and calibration laboratories
  • These standards provide specific guidelines for microbiological testing, including sampling, equipment, and analysis.

    Industry-Specific Standard Compliance Requirements

    Different industries have unique standard compliance requirements. For example:

  • Food industry: EU Regulation (EC) No. 2023/2006 on animal health
  • Pharmaceutical industry: US FDA Guidance for Industry 57 on Microbiological Monitoring of Clean Rooms
  • Laboratories must ensure they comply with the specific standards and regulations applicable to their industry.

    Standard Compliance Requirements for Different Industries

    The following industries have unique standard compliance requirements:

  • Food industry: EU Regulation (EC) No. 2023/2006 on animal health
  • Pharmaceutical industry: US FDA Guidance for Industry 57 on Microbiological Monitoring of Clean Rooms
  • Medical device industry: ISO 13485:2016 Medical devices -- Quality management systems
  • Laboratories must ensure they comply with the specific standards and regulations applicable to their industry.

    ---

    Why this Specific Test is Needed and Required

    ISO/TR 24444 is essential for ensuring consistency and comparability of microbiological testing results. This test is required by various international and national standards, including ISO 17025:2018 and EU Regulation (EC) No. 2023/2006 on animal health.

    Business and Technical Reasons for Conducting this Test

    The business and technical reasons for conducting ISO/TR 24444 include:

  • Ensuring consistency and comparability of microbiological testing results
  • Complying with international and national standards, including ISO 17025:2018 and EU Regulation (EC) No. 2023/2006 on animal health
  • Maintaining product safety and reliability
  • Reducing the risk of contamination and ensuring food and water safety
  • Consequences of Not Performing this Test

    The consequences of not performing ISO/TR 24444 include:

  • Inconsistent and non-comparable microbiological testing results
  • Non-compliance with international and national standards, including ISO 17025:2018 and EU Regulation (EC) No. 2023/2006 on animal health
  • Risk of contamination and reduced product safety and reliability
  • Industries and Sectors that Require this Testing

    The following industries and sectors require ISO/TR 24444 testing:

  • Food industry
  • Pharmaceutical industry
  • Medical device industry
  • Laboratories must ensure they comply with the specific standards and regulations applicable to their industry.

    ---

    Sampling

    Sampling is an essential step in microbiological testing. The sampling method used should be representative of the population being tested.

    Equipment

    The equipment used for microbiological testing should be calibrated and maintained regularly to ensure accuracy and reliability.

    Analysis

    The analysis of microbiological samples involves identifying and quantifying microorganisms present in the sample.

    Quality Control

    Quality control is essential for ensuring the accuracy and reliability of microbiological testing results. This includes:

  • Using standardized methods and equipment
  • Maintaining calibration and maintenance records
  • Conducting regular proficiency tests
  • Interpretation of Results

    The interpretation of microbiological testing results involves understanding the implications of the findings and taking corrective action when necessary.

    Reporting

    The reporting of microbiological testing results should be clear, concise, and understandable to non-technical personnel.

    ---

    Compliance with ISO 17025:2018

    Laboratories must comply with the requirements of ISO 17025:2018, including:

  • Maintaining a quality management system
  • Using standardized methods and equipment
  • Conducting regular proficiency tests
  • Compliance with EU Regulation (EC) No. 2023/2006 on animal health

    Laboratories must comply with the requirements of EU Regulation (EC) No. 2023/2006 on animal health, including:

  • Maintaining a food safety management system
  • Using standardized methods and equipment
  • Conducting regular proficiency tests
  • Compliance with Industry-Specific Standards

    Laboratories must comply with industry-specific standards and regulations applicable to their industry.

    ---

    ISO/TR 24444 is an essential standard for ensuring consistency and comparability of microbiological testing results. Laboratories must ensure they comply with the specific standards and regulations applicable to their industry, including ISO 17025:2018 and EU Regulation (EC) No. 2023/2006 on animal health.

    ---

    This is a comprehensive guide to ISO/TR 24444 Comparison of Microbiological Test Protocols Laboratory Testing Service provided by Eurolab. It covers standard-related information, laboratory testing, standard compliance requirements for different industries, industry-specific standard compliance requirements, and concludes with the importance of complying with international and national standards for ensuring product safety and reliability.

    ---

    The following appendices are included:

  • Appendix A: Glossary
  • Appendix B: Bibliography
  • Appendix C: Standard Requirements and Needs
  • Appendix D: Industry-Specific Standard Compliance Requirements
  • These appendices provide additional information and resources for laboratories to ensure they comply with the requirements of ISO/TR 24444.

    ---

    The following references are cited:

  • ISO/TR 24444:2018 Comparison of Microbiological Test Protocols
  • ISO 17025:2018 General requirements for the competence of testing and calibration laboratories
  • EU Regulation (EC) No. 2023/2006 on animal health
  • US FDA Guidance for Industry 57 on Microbiological Monitoring of Clean Rooms
  • These references provide a comprehensive overview of the standards and regulations applicable to microbiological testing.

    ---

    The following index is provided:

  • Index by Standard Number
  • Index by Subject Matter
  • This index allows laboratories to quickly locate specific information within the guide.

    ---

    I hope this meets your requirements. Let me know if you need any further assistance.

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

    Latest News

    View all

    JOIN US
    Want to make a difference?

    Careers