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fda-bam-chapter-23-microbial-pathogen-detection-in-preserved-products
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 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 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 FDA BAM Chapter 23 Microbial Pathogen Detection in Preserved Products Laboratory Testing Service

The FDA BAM (Bacteriological Analytical Manual) Chapter 23 Microbial Pathogen Detection in Preserved Products testing is a laboratory test that involves the detection of microorganisms in preserved products. This chapter outlines the standard methods for detecting and identifying microbial pathogens in these products.

Relevant Standards:

  • ISO 11133:2006 (Microbiology of food and animal feeding stuffs -- Guidelines on preparation and production of culture media)

  • ASTM E2499-05 (Standard Practice for Testing of Microorganisms in Foods and Water by the Conventional Method)

  • EN ISO 21528-1:2017 (Determination of preservative efficacy in foods - Part 1: General method)

  • TSE 1346:2005 (Microbiological analysis of foodstuffs -- Detection of Salmonella and Campylobacter)

    • Standard Development Organizations:

    The standard development organizations that govern the FDA BAM Chapter 23 testing include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • International and National Standards:

    The international standards that apply to this specific laboratory test are ISO 11133, ASTM E2499-05, EN ISO 21528-1:2017, and TSE 1346:2005. These standards outline the methods for detecting and identifying microbial pathogens in preserved products.

    Standard Compliance Requirements:

    The standard compliance requirements for different industries include:

  • Food industry: ISO 11133, ASTM E2499-05

  • Pharmaceutical industry: EN ISO 21528-1:2017

  • Cosmetics industry: TSE 1346:2005

    • Why this Test is Needed and Required:

    This test is needed to ensure the safety of preserved products by detecting and identifying microbial pathogens that can cause spoilage, contamination, or even foodborne illnesses.

    Business and Technical Reasons for Conducting FDA BAM Chapter 23 Microbial Pathogen Detection in Preserved Products Testing:

    The business and technical reasons for conducting this testing include:

  • Ensuring product safety and quality

  • Compliance with regulatory requirements

  • Reducing the risk of contamination and spoilage

  • Protecting public health

    • Consequences of Not Performing this Test:

    The consequences of not performing this test include:

  • Product recalls

  • Loss of market share

  • Financial losses

  • Damage to brand reputation

    • Industries and Sectors that Require this Testing:

    The industries and sectors that require this testing include:

  • Food industry (meat, dairy, bakery)

  • Pharmaceutical industry

  • Cosmetics industry

  • Biotechnology industry

    • Risk Factors and Safety Implications:

    The risk factors and safety implications associated with microbial pathogens in preserved products include:

  • Foodborne illnesses

  • Contamination of food products

  • Spoilage of food products

  • Economic losses

    • Quality Assurance and Quality Control Aspects:

    The quality assurance and quality control aspects of this testing include:

  • Use of validated methods and protocols

  • Calibration and validation of equipment

  • Maintenance of laboratory records and documentation

  • Implementation of quality control measures during testing

    • Why this Test Contributes to Product Safety and Reliability:

    This test contributes to product safety and reliability by ensuring that preserved products are free from microbial pathogens.

    Competitive Advantages of Having this Testing Performed:

    The competitive advantages of having this testing performed include:

  • Compliance with regulatory requirements

  • Improved product quality and safety

  • Increased customer confidence and trust

  • Market differentiation

    • Cost-Benefit Analysis of Performing this Test:

    The cost-benefit analysis of performing this test includes:

  • Cost savings through reduced product recalls and contamination

  • Increased revenue through improved market share and competitiveness

  • Reduced regulatory penalties and fines

    • Detailed Step-by-Step Explanation of How the Test is Conducted:

    The detailed step-by-step explanation of how the test is conducted includes:

  • Sample collection and preparation

  • Equipment calibration and validation

  • Testing parameters and conditions

  • Measurement and analysis methods

  • Data collection and recording procedures

    • Testing Equipment and Instruments Used:

    The testing equipment and instruments used include:

  • Microbiological analyzers (e.g., plate readers, spectrophotometers)

  • Incubators and temperature control units

  • Centrifuges and centrifugal separators

  • Pipettes and automatic pipetting systems

    • Sample Preparation Procedures:

    The sample preparation procedures include:

  • Sample collection and transportation

  • Sample homogenization and dilution

  • Inoculation of samples onto agar plates or in broth cultures

    • Measurement and Analysis Methods:

    The measurement and analysis methods used include:

  • Bacterial enumeration (e.g., plate counts, colony-forming units)

  • Identification of microbial pathogens using biochemical tests and molecular techniques (e.g., PCR, DNA sequencing)

    • Data Collection and Recording Procedures:

    The data collection and recording procedures include:

  • Data entry into laboratory information management systems

  • Record-keeping and documentation

    • Why this Test is Accurate and Reliable:

    This test is accurate and reliable due to the use of validated methods and protocols.

    Standard Operating Procedures (SOPs):

    The SOPs for this testing include:

  • Sample preparation procedures

  • Equipment calibration and validation procedures

  • Testing parameters and conditions

  • Measurement and analysis methods

    • Test Results and Interpretation:

    The test results and interpretation include:

  • Calculation of bacterial loads or concentrations

  • Identification of microbial pathogens

  • Determination of test outcomes (e.g., pass/fail, positive/negative)

    • Why this Test is Compliant with Regulatory Requirements:

    This test is compliant with regulatory requirements due to the use of validated methods and protocols.

    Test Results Reporting and Record-Keeping:

    The test results reporting and record-keeping include:

  • Preparation of test reports

  • Maintenance of laboratory records and documentation

    • Why this Test Contributes to Product Safety and Quality:

    This test contributes to product safety and quality by ensuring that preserved products are free from microbial pathogens.

    Persuasive Statement:

    By conducting the FDA BAM Chapter 23 Microbial Pathogen Detection in Preserved Products testing, companies can ensure the safety and quality of their products, reduce regulatory risks, and maintain customer confidence and trust. This test is a critical component of any quality control program and should be performed regularly to ensure compliance with regulatory requirements.

    This comprehensive guide provides a detailed overview of the FDA BAM Chapter 23 Microbial Pathogen Detection in Preserved Products testing, including standard-related information, business and technical reasons for conducting this testing, consequences of not performing this test, industries and sectors that require this testing, risk factors and safety implications, quality assurance and quality control aspects, competitive advantages, cost-benefit analysis, test conditions and methodology, and persuasive statement.

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