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usp-51-antimicrobial-effectiveness-testing-preservative-challenge-test
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 24444 Comparison of Microbiological Test ProtocolsISO/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 <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

Comprehensive Guide to USP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test)

Provided by Eurolab

Standard-Related Information

USP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test) is a laboratory testing service that evaluates the effectiveness of preservatives in preventing microbial growth on pharmaceutical products. The test is governed by various international and national standards, including:

  • USP <51> Antimicrobial Effectiveness Testing

  • ISO 21148:2013 Preservatives for Cosmetics - Determination of the Efficacy of Preservatives against Fungi and Yeast

  • ASTM E2197-13 Standard Test Method for Determining the Efficacy of Disinfectants Against Influenza A Virus on Non-Porous Surfaces

  • EN 1500:2012 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic hygiene against viruses and bacteria

    • These standards outline the requirements for conducting antimicrobial effectiveness testing, including the selection of microorganisms, test conditions, and evaluation criteria.

    Standard Requirements and Needs

    The USP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test) is required to ensure that pharmaceutical products do not support the growth of microorganisms. This test helps prevent contamination, spoilage, and potential health risks associated with microbial growth on products.

    Conducting this test is essential for several reasons:

  • Ensures product safety and efficacy

  • Prevents costly recalls and reputational damage

  • Complies with regulatory requirements

  • Enhances customer confidence and trust

    • Industries that Require This Testing

    The following industries require USP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test):

  • Pharmaceutical manufacturing

  • Cosmetics and personal care products

  • Medical device manufacturers

  • Food processing and packaging

  • Water treatment and purification

    • Test Conditions and Methodology

    The test involves the following steps:

    1. Sample preparation: Preparation of a representative sample of the product to be tested.

    2. Microbial inoculation: Inoculation of microorganisms onto the product sample using an agar-based medium.

    3. Incubation: Incubation of the inoculated samples at a specified temperature (typically 25C or 30C) for a specified period (usually 14 days).

    4. Evaluation: Evaluation of the test results to determine if microbial growth has occurred.

    The testing equipment and instruments used include:

  • Microbial counting chambers

  • Agar-based medium

  • Incubators

  • Microscopes

    • Test Reporting and Documentation

    Test results are documented in a comprehensive report that includes:

  • Test methodology

  • Sample preparation procedures

  • Results of microbial counts

  • Evaluation of test data

  • Conclusion and recommendations

    • Reports are issued in accordance with regulatory requirements, including:

  • USP <51>

  • ISO 21148:2013

  • ASTM E2197-13

  • EN 1500:2012

    • Why This Test Should Be Performed

    Performing the USP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test) provides numerous benefits, including:

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance with regulatory requirements

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

  • Legal and regulatory compliance benefits

  • Customer confidence and trust building

    • Why Eurolab Should Provide This Service

    Eurolab offers a comprehensive range of services for USP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test), including:

  • Expertise and experience in the field

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

    • Eurolabs quality management systems and procedures ensure that all testing is conducted to the highest standards, providing customers with confidence in the results.

    Additional Information

    Industry-specific examples and case studies are provided below:

  • Pharmaceutical manufacturers: Conducting antimicrobial effectiveness testing ensures compliance with regulatory requirements and prevents product contamination.

  • Cosmetics and personal care products: Antimicrobial effectiveness testing helps prevent microbial growth on products, ensuring customer safety and satisfaction.

  • Medical device manufacturers: Testing for antimicrobial efficacy is crucial to ensure that devices do not support the growth of microorganisms.

    • Conclusion

    USP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test) is a critical laboratory testing service that evaluates the effectiveness of preservatives in preventing microbial growth on pharmaceutical products. This comprehensive guide has provided an overview of the standard-related information, requirements, and needs for conducting this test.

    Eurolab offers a range of services for USP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test), including expert testing, equipment, and facilities. Contact Eurolab today to learn more about how our laboratory testing services can help you ensure product safety and compliance with regulatory requirements.

    References

  • USP <51> Antimicrobial Effectiveness Testing

  • ISO 21148:2013 Preservatives for Cosmetics - Determination of the Efficacy of Preservatives against Fungi and Yeast

  • ASTM E2197-13 Standard Test Method for Determining the Efficacy of Disinfectants Against Influenza A Virus on Non-Porous Surfaces

  • EN 1500:2012 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic hygiene against viruses and bacteria

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