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iso-11930-microbiological-preservation-efficacy-testing
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 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 <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

Comprehensive Guide to ISO 11930 Microbiological Preservation Efficacy Testing Services by Eurolab

ISO 11930 is a widely recognized international standard for microbiological preservation efficacy testing, developed by the International Organization for Standardization (ISO). This standard provides guidelines and requirements for evaluating the effectiveness of preservation methods in preventing microbial growth in various products. In this section, we will delve into the relevant standards, legal and regulatory framework, and standard development organizations.

Relevant Standards:

  • ISO 11930:2015(E) - Microbiological preservation efficacy testing

  • ASTM E2187-07(2020) - Standard Test Method for Evaluating the Effectiveness of Preservation Methods in Preventing Microbial Growth

  • EN ISO 11885:2009 - Water quality Determination of dissolved oxygen by Winklers method

  • TSE (Turkish Standards Institution) TS 13465:2017 - Foodstuffs -- Preservation efficacy testing

    • Legal and Regulatory Framework:

    The legal and regulatory framework surrounding microbiological preservation efficacy testing is primarily governed by national and international regulations. In the European Union, for instance, Regulation (EC) No 1935/2004 on food contact materials specifies the requirements for food contact materials, including preservation efficacy testing.

    Standard Development Organizations:

    ISO 11930 was developed by Technical Committee ISO/TC 34, which focuses on packaging and handling of all types of packages. The standard is maintained and updated by this committee in collaboration with other international organizations.

    Evolution and Update of Standards:

    Standards undergo regular review and update to reflect changes in technology, regulations, and industry practices. For example, ISO 11930 was revised in 2015 to incorporate new methods for evaluating preservation efficacy.

    Standard Numbers and Scope:

  • ISO 11930:2015(E) - This standard specifies the requirements for microbiological preservation efficacy testing.

  • ASTM E2187-07(2020) - This standard provides a test method for evaluating the effectiveness of preservation methods in preventing microbial growth.

    • Industry-Specific Compliance Requirements:

    Compliance with relevant standards and regulations is essential for industries such as food, pharmaceuticals, cosmetics, and medical devices. These industries must adhere to specific requirements outlined in national and international standards, including ISO 11930.

  • Why this standard is important: The preservation efficacy testing specified in ISO 11930 ensures that products are safe for consumption or use, preventing the growth of microorganisms that can cause spoilage or contamination.

  • Benefits of compliance:

    • Ensures product safety and quality

    Prevents costly recalls and reputational damage

    Enhances customer confidence and trust

    Facilitates international trade

    ISO 11930 Microbiological Preservation Efficacy Testing is a critical test for ensuring the safety and quality of products. In this section, we will discuss why this specific test is needed and required.

    Why this Specific Test is Needed:

    The preservation efficacy testing specified in ISO 11930 ensures that products are safe for consumption or use by preventing microbial growth. This is particularly important for industries such as food, pharmaceuticals, cosmetics, and medical devices, where product safety and quality are paramount.

    Business and Technical Reasons for Conducting the Test:

    Conducting preservation efficacy testing provides several business and technical benefits:

  • Ensures product safety and quality

  • Prevents costly recalls and reputational damage

  • Enhances customer confidence and trust

  • Facilitates international trade

    • Consequences of Not Performing this Test:

    Failure to conduct preservation efficacy testing can have severe consequences, including:

  • Product contamination or spoilage

  • Customer complaints and lost business

  • Reputational damage and financial losses

  • Regulatory non-compliance and fines

    • Industries and Sectors that Require this Testing:

    This test is essential for industries such as food, pharmaceuticals, cosmetics, and medical devices.

    Risk Factors and Safety Implications:

    Preservation efficacy testing helps mitigate risk factors associated with product contamination or spoilage. Failure to conduct this test can result in serious safety implications, including:

  • Foodborne illnesses

  • Product recalls and reputational damage

  • Financial losses and regulatory non-compliance

    • Quality Assurance and Quality Control Aspects:

    Conducting preservation efficacy testing as specified in ISO 11930 ensures that products meet quality standards and regulations.

    In this section, we will provide a detailed step-by-step explanation of how the test is conducted.

    Step 1: Sample Preparation

  • Select representative samples from each product batch

  • Prepare samples according to standard requirements

    • Step 2: Testing Equipment and Instruments

  • Use specialized equipment and instruments for microbiological preservation efficacy testing, such as incubators, microscopes, and spectrophotometers

    • Step 3: Preservation Efficacy Testing

  • Conduct preservation efficacy testing using the methods specified in ISO 11930

  • Evaluate the effectiveness of preservation methods in preventing microbial growth

    • Step 4: Data Analysis and Reporting

  • Analyze data from preservation efficacy testing

  • Prepare a report outlining test results, conclusions, and recommendations for improving product safety and quality.

  • Why this specific method is used: The preservation efficacy testing specified in ISO 11930 is widely accepted and recognized as the standard for evaluating the effectiveness of preservation methods.

  • Benefits of using this test:

    • Ensures product safety and quality

    Prevents costly recalls and reputational damage

    Enhances customer confidence and trust

    Facilitates international trade

    Conclusion

    In conclusion, ISO 11930 Microbiological Preservation Efficacy Testing is a critical test for ensuring the safety and quality of products. Conducting this test as specified in the standard ensures that products meet regulatory requirements and industry standards.

    Next Steps:

  • Contact Eurolab to learn more about preservation efficacy testing services

  • Schedule a consultation with our expert team to discuss your specific needs and requirements

    • Please note that this is a comprehensive guide, and not all sections are included. If you have any questions or need further clarification, please dont hesitate to contact us.

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