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usp-1227-validation-of-microbial-recovery-in-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 Aerobic Bacteria for Preservative StudiesISO 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 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

USP <1227> Validation of Microbial Recovery in Preservative Studies: Laboratory Testing Services Provided by Eurolab

The USP <1227> Validation of Microbial Recovery in Preservative Studies is a comprehensive testing standard that ensures the effectiveness of preservatives in preventing microbial growth in pharmaceutical products. This standard is part of the United States Pharmacopeia (USP) chapter on antimicrobial preservation, which provides guidelines for the development and validation of antimicrobial preservation systems.

The USP <1227> standard is based on international standards, including ISO 11133:2014, ASTM E2180-09, and EN 12341:2006. These standards provide a framework for testing the efficacy of preservatives in various pharmaceutical products, including parenterals, ophthalmics, and topical preparations.

International and National Standards

The USP <1227> standard is recognized globally as an international standard for antimicrobial preservation testing. Many countries have adopted this standard as their national standard, including the United States, Canada, Australia, and Japan.

In addition to USP <1227>, several other standards are relevant to antimicrobial preservation testing, including:

  • ISO 11133:2014 - Microbiological examination of medical products - Particular requirements for processing and testing of pharmaceutical grade water

  • ASTM E2180-09 - Standard Test Method for Determination of Antimicrobial Activity of Antimicrobial Agents in Suspension

  • EN 12341:2006 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity

    • Standard Development Organizations

    Several standard development organizations play a crucial role in developing and maintaining standards related to antimicrobial preservation testing, including:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations work together to develop and maintain international standards that ensure the quality and safety of pharmaceutical products.

    Why This Test Should Be Performed

    The USP <1227> Validation of Microbial Recovery in Preservative Studies is essential for ensuring the efficacy of antimicrobial preservation systems in various pharmaceutical products. Failure to perform this test can result in microbial contamination, which can lead to product recalls, loss of reputation, and even harm to patients.

    Consequences of Not Performing This Test

    The consequences of not performing the USP <1227> Validation of Microbial Recovery in Preservative Studies are severe:

  • Product recalls

  • Loss of reputation

  • Harm to patients

  • Financial losses

    • Industries and Sectors that Require this Testing

    Several industries and sectors require antimicrobial preservation testing, including:

  • Pharmaceuticals

  • Biotechnology

  • Cosmetics

  • Food and Beverage

    • These industries rely on the effectiveness of preservatives to prevent microbial growth in their products.

    Risk Factors and Safety Implications

    Antimicrobial preservation testing is essential for ensuring product safety. Failure to perform this test can result in microbial contamination, which can lead to:

  • Product recalls

  • Loss of reputation

  • Harm to patients

  • Financial losses

    • Quality Assurance and Quality Control Aspects

    The USP <1227> Validation of Microbial Recovery in Preservative Studies is an essential component of quality assurance and quality control programs. This test ensures that antimicrobial preservation systems are effective in preventing microbial growth.

    Competitive Advantages of Having this Testing Performed

    Performing the USP <1227> Validation of Microbial Recovery in Preservative Studies provides several competitive advantages, including:

  • Enhanced product safety

  • Improved reputation

  • Increased customer confidence

  • Compliance with regulatory requirements

    • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of performing the USP <1227> Validation of Microbial Recovery in Preservative Studies is clear:

  • Cost savings through reduced product recalls and losses

  • Enhanced product safety

  • Improved reputation

  • Increased customer confidence

    • ---

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