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iso-21149-enumeration-of-aerobic-bacteria-for-preservative-studies
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 Microorganisms in Preserved FormulationsISO 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

ISO 21149 Enumeration of Aerobic Bacteria for Preservative Studies: Laboratory Testing Services

Standard-Related Information

ISO 21149 is an international standard that specifies the method for enumerating aerobic bacteria in products containing preservatives, such as foodstuffs, pharmaceuticals, and cosmetics. This standard is developed by the International Organization for Standardization (ISO) and is widely adopted globally.

The standard is based on the principles of microbiological testing, which involves culturing and counting microorganisms to determine their presence and quantity in a sample. The ISO 21149 method specifically targets aerobic bacteria, which are capable of growing in the absence of oxygen.

Relevant Standards

Several standards govern the ISO 21149 Enumeration of Aerobic Bacteria for Preservative Studies testing service:

  • ISO 11133:2014 - Microbiology of food and animal feeding stuffs Preparation, production, storage and performance testing of culture media
  • ISO 11134:2008 - Microbiology of food and animal feeding stuffs Horizontal method for the detection of Salmonella spp.
  • ASTM E1175-14 - Standard Test Method for Enumeration of Aerobic Bacteria in Bottled Water by Membrane Filtration
  • Standard Development Organizations

    The International Organization for Standardization (ISO) is a non-governmental organization that develops and publishes international standards. The ISO 21149 standard was developed through a consensus-based process involving experts from various countries and industries.

    Legal and Regulatory Framework

    The legal and regulatory framework surrounding the ISO 21149 Enumeration of Aerobic Bacteria for Preservative Studies testing service varies by country and industry. In general, manufacturers must comply with national regulations and standards to ensure product safety and quality.

    In the European Union (EU), for example, Regulation (EC) No 178/2002 on foodstuffs sets out the principles for ensuring food safety, including microbiological testing.

    International and National Standards

    The following international and national standards apply to the ISO 21149 Enumeration of Aerobic Bacteria for Preservative Studies testing service:

  • International: ISO 21149, ASTM E1175-14
  • European Union: EN 11133:2014 (formerly known as BS EN 11133)
  • United States: ASTM E1175-14
  • Standard Compliance Requirements

    To comply with the ISO 21149 standard, manufacturers must follow specific procedures for sampling, testing, and reporting. The following are some key requirements:

    1. Sampling: Select a representative sample from the product.

    2. Testing: Conduct microbiological testing using an accredited laboratory.

    3. Reporting: Provide accurate and reliable test results.

    Business and Technical Reasons for Conducting ISO 21149 Enumeration of Aerobic Bacteria for Preservative Studies Testing

    The following are some business and technical reasons why manufacturers should conduct ISO 21149 Enumeration of Aerobic Bacteria for Preservative Studies testing:

  • Ensure product safety and quality
  • Meet regulatory requirements
  • Protect brand reputation and customer trust
  • Maintain market share and competitiveness
  • Consequences of Not Performing This Test

    Failure to conduct the ISO 21149 Enumeration of Aerobic Bacteria for Preservative Studies test can result in:

    1. Regulatory non-compliance

    2. Product recalls or withdrawals

    3. Damage to brand reputation and customer trust

    4. Financial losses due to product contamination

    Industries and Sectors Requiring This Testing

    The following industries and sectors require the ISO 21149 Enumeration of Aerobic Bacteria for Preservative Studies testing:

    1. Food and beverage manufacturing

    2. Pharmaceutical and cosmetics industries

    3. Bottled water and beverages

    4. Animal feed and pet food

    Risk Factors and Safety Implications

    Failure to detect or control aerobic bacteria in products can lead to various health risks, including:

    1. Product contamination

    2. Allergic reactions or intolerance

    3. Foodborne illnesses

    4. Infections or diseases

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