EUROLAB
iso-21149-enumeration-of-microorganisms-in-preserved-formulations
Preservative Efficacy Testing AOAC 2003.07 Challenge Testing for Preservative EffectivenessAOAC 2007.01 Microbial Challenge Testing for PreservativesAOAC 991.14 Microbial Contamination Analysis in Preserved ProductsAOAC 997.02 Challenge Test Method for Preservative EffectivenessASTM D4014 Preservative Testing for Creams and LotionsASTM D5412 Microbial Limits Testing in Preserved CosmeticsASTM D6422 Preservative Effectiveness in Personal Care ProductsASTM E2180 Antimicrobial Activity of Preservative SystemsASTM E2181 Preservative Efficacy Testing for CosmeticsASTM E2315 Preservation Challenge Test for Cosmetic ProductsASTM E2315 Time-Kill Method for Preservative AssessmentASTM E2315-16 Time-Kill Kinetics for Preservative EffectivenessASTM E2316 Microbial Assessment of Cosmetic PreservativesASTM E2317 Antimicrobial Efficacy of Cosmetic PreservativesASTM E2709 Challenge Tests for Preservative SystemsASTM E2799 Antimicrobial Effectiveness Testing for CosmeticsCOLIPA Guidelines for Preservative Efficacy in CosmeticsEN ISO 11930 Microbial Preservation Testing for Personal CareEN ISO 11930 Microbial Quality and Preservation AssessmentEP 2.6.12 Enumeration of Microorganisms in Preserved ProductsEP 2.6.13 Detection of Specified Microorganisms in Preserved ProductsEP 5.1.3 Challenge Test for Preservative EfficacyEP 5.1.4 Microbial Limits in Preserved IngredientsEP 5.1.5 Microbial Quality Control in Preserved FormulationsFDA 21 CFR 701.3 Microbial Contamination Limits in Preserved ProductsFDA 21 CFR Part 700 Microbial Limits for Preserved CosmeticsFDA BAM Chapter 23 Microbial Pathogen Detection in Preserved ProductsFDA Cosmetic Microbiological Testing GuidanceFDA Guidance on Preservative Testing for Topical ProductsISO 10993-10 Preservation Efficacy in Dermal ProductsISO 10993-12 Sample Preparation for Preservative TestingISO 11930 Challenge Test of Preservatives in CosmeticsISO 11930 Evaluation of Preservative Efficacy in CosmeticsISO 11930-1 Preservative Challenge Testing for Rinse-off ProductsISO 11930-2 Preservative Testing of Leave-on CosmeticsISO 11932 Validation of Microbial Methods in Preservation TestingISO 11989 Validation of Microbiological Methods in Preserved ProductsISO 16128 Natural and Organic Cosmetic Ingredient PreservationISO 16128-2 Calculation of Natural Preservative ContentISO 16134-3 Testing of Preservative EffectivenessISO 16212 Detection of Yeasts and Molds in Preserved CosmeticsISO 16212 Mold and Yeast Quantification in Preserved CosmeticsISO 17516 Microbial Limits and Preservation TestingISO 18415 Microbial Challenge Test for Personal Care ProductsISO 18593 Microbial Sampling in Preserved ProductsISO 18593 Microbiological Sampling Methods for Preserved ProductsISO 21148 Detection of Anaerobic Microorganisms in Preserved ProductsISO 21148 Detection of Preservative-Resistant MicroorganismsISO 21149 Enumeration of Aerobic Bacteria for Preservative StudiesISO 21149-1 Enumeration of Aerobic Bacteria in Preserved FormulationsISO 21150 Detection of Pathogens in Preserved CosmeticsISO 21150-1 Microbial Contamination in Cosmetic Raw MaterialsISO 21404 Testing for Microbial Contamination in Preserved CosmeticsISO 21702 Antiviral Efficacy Testing of PreservativesISO 22176 Good Hygiene Practices for Preserved CosmeticsISO 22716 Good Manufacturing Practices for Cosmetic PreservationISO 24434 Enumeration of Aerobic Mesophilic Spores in Preserved ProductsISO 24441 SPF Testing for Preserved SunscreensISO 24442 Enumeration of Aerobic Microbial Spores in ProductsISO 24442 Microbial Spores Enumeration in Preserved ProductsISO 24444 Comparison of Microbiological Test ProtocolsISO 24475 Microbiological Assessment of Preserved Raw MaterialsISO 29621 Categorization of Cosmetic Products by Microbiological RiskISO/TR 19837 Guidelines for Microbiological Risk Assessment of PreservativesISO/TR 19838 Risk Management of Preservatives in CosmeticsISO/TR 19930 Microbiological Test Method Development for PreservativesISO/TR 24476 Selection of Microbiological Test Methods for PreservationISO/TR 29621 Guidelines on Risk Assessment for PreservativesUSP <1227> Validation of Microbial Recovery in Preservative StudiesUSP <1227> Validation of Microbial Recovery in Preservative TestingUSP <1229> Microbial Recovery in Preservative Efficacy TestsUSP <1231> Water Quality for Microbiological Control in Preservative TestingUSP <1625> Microbial Testing of Preserved Topical ProductsUSP <51> Antimicrobial Effectiveness Testing for PreservativesUSP <60> Microbial Limits in Preserved CosmeticsUSP <61> Microbial Enumeration Tests in Preserved Cosmetics

Comprehensive Guide to Eurolabs ISO 21149 Enumeration of Microorganisms in Preserved Formulations Laboratory Testing Service

Standard-Related Information

ISO 21149 is an international standard that provides guidelines for the enumeration of microorganisms in preserved formulations, including food products, cosmetics, and pharmaceuticals. This standard is developed by the International Organization for Standardization (ISO) to ensure consistency and accuracy in testing methods.

The relevant standards that govern ISO 21149 Enumeration of Microorganisms in Preserved Formulations testing are:

  • ISO 21149:2019(E)
  • ASTM E1475-19
  • EN ISO 11133-1:2020
  • TSE L35.3.2.1.4 (Turkey)
  • The legal and regulatory framework surrounding this testing service is governed by national and international laws, regulations, and guidelines, such as:

  • Good Manufacturing Practice (GMP)
  • Hazard Analysis Critical Control Points (HACCP)
  • International Organization for Standardization (ISO) 9001:2015
  • Standard development organizations play a crucial role in the development of standards. Some notable organizations include:

  • ISO
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • Standards evolve over time to reflect changes in technology, science, and industry needs. Eurolab stays up-to-date with the latest standards and regulations through its accreditation and certification programs.

    Standard Requirements and Needs

    The ISO 21149 Enumeration of Microorganisms in Preserved Formulations testing is required for several reasons:

    1. Product Safety: This test ensures that preserved formulations are free from microorganisms, which can pose a risk to human health.

    2. Quality Assurance: The test helps manufacturers ensure the quality of their products and maintain customer confidence.

    3. Regulatory Compliance: Manufacturers must comply with regulations and standards set by national and international authorities.

    The industries that require this testing include:

    1. Food Industry

    2. Cosmetics Industry

    3. Pharmaceutical Industry

    The consequences of not performing this test can be severe, including product recalls, financial losses, and damage to reputation.

    Test Conditions and Methodology

    The ISO 21149 Enumeration of Microorganisms in Preserved Formulations testing involves several steps:

    1. Sample Preparation: Prepare the sample according to the standards requirements.

    2. Inoculation: Inoculate the sample with a specific number of microorganisms.

    3. Incubation: Incubate the inoculated sample under controlled conditions (temperature, humidity, etc.).

    4. Enumeration: Count the number of microorganisms present in the sample using specialized equipment.

    The testing equipment and instruments used include:

    1. Microbiological incubators

    2. Enumeration software

    3. Pipettes

    4. Autoclaves

    The testing environment requirements include:

    1. Temperature control (25C 2C)

    2. Humidity control (50 10)

    3. Pressure control (1013 mbar 5)

    Test Reporting and Documentation

    Eurolabs test report includes the following information:

    1. Summary: A brief summary of the testing results.

    2. Results: The enumeration results, including the number of microorganisms present in the sample.

    3. Conclusions: Interpretation of the testing results.

    The test report is structured according to the ISO 9001:2015 standard and includes a unique identification number for traceability purposes.

    Why This Test Should Be Performed

    Performing the ISO 21149 Enumeration of Microorganisms in Preserved Formulations testing provides several benefits, including:

    1. Risk Assessment: The test helps manufacturers identify potential risks associated with their products.

    2. Quality Assurance: The test ensures that products meet quality standards and regulations.

    3. Compliance: Manufacturers can demonstrate compliance with national and international regulations.

    4. Customer Confidence: The test builds customer confidence in the products safety and quality.

    Why Eurolab Should Provide This Service

    Eurolab provides this service because of its:

    1. Expertise: Eurolab has extensive experience in microbiological testing and analysis.

    2. State-of-the-Art Equipment: Eurolab uses modern, high-precision equipment for accurate results.

    3. Accreditation: Eurolab is accredited to ISO 17025:2018 and follows the principles of quality management according to ISO 9001:2015.

    4. International Recognition: Eurolab is recognized by international organizations and partners.

    Eurolabs capabilities in providing this service include:

    1. Turnaround Time: Fast turnaround times without compromising accuracy or precision.

    2. Competitive Pricing: Competitive pricing while maintaining high-quality services.

    3. Customer Support: Dedicated customer support for any queries or concerns.

    4. Technical Consultation: Expert technical consultation and advice on testing and analysis.

    Conclusion

    The ISO 21149 Enumeration of Microorganisms in Preserved Formulations testing is a critical step in ensuring product safety, quality assurance, and regulatory compliance. Eurolabs expertise, state-of-the-art equipment, accreditation, and international recognition make it the ideal partner for manufacturers seeking to demonstrate their commitment to product safety and quality.

    References

  • ISO 21149:2019(E)
  • ASTM E1475-19
  • EN ISO 11133-1:2020
  • TSE L35.3.2.1.4 (Turkey)
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