EUROLAB
fda-bam-chapter-3-aerobic-plate-count-for-food-and-supplements
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

FDA BAM Chapter 3 Aerobic Plate Count for Food and Supplements: Laboratory Testing Services Provided by Eurolab

The FDA BAM Chapter 3 Aerobic Plate Count for Food and Supplements testing service is governed by a range of international and national standards. These standards ensure that the testing process is carried out with precision, accuracy, and consistency.

International Standards

  • ISO 4832:2006 - General guidelines on the enumeration of microorganisms in butter and other fat products
  • ISO 6227:2013 - Microbiology of food and animal feeding stuffs -- Horizontal method for the detection and enumeration of yeasts and moulds
  • ASTM E1791-10(2016) - Standard Test Method for Aerobic Plate Count (APC) of Food and Water
  • EN 12896:2007 - Microbiology of food and animal feeding stuffs -- Horizontal method for the detection and enumeration of Escherichia coli
  • National Standards

  • FDA BAM Chapter 3 Aerobic Plate Count for Food and Supplements
  • USDA-FSIS (Food Safety and Inspection Service) regulations on microbiological examination of meat, poultry, and egg products
  • EU legislation on food safety, including Regulation (EC) No. 2073/2005 on microbiological criteria for food
  • Standard Development Organizations

    The development and maintenance of international and national standards are the responsibility of organizations such as:

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • Turkish Standards Institution (TSE)
  • These organizations ensure that standards evolve and get updated regularly to reflect changes in technology, scientific knowledge, and regulatory requirements.

    Compliance Requirements

    Compliance with relevant standards is mandatory for industries such as food processing, pharmaceuticals, and cosmetics. Failure to comply can result in product recalls, fines, and loss of business reputation.

    The FDA BAM Chapter 3 Aerobic Plate Count for Food and Supplements testing service is required due to the potential risks associated with microbial contamination in food products. These risks include:

  • Foodborne illnesses
  • Economic losses due to product recalls or contamination
  • Damage to brand reputation
  • Business and Technical Reasons

    The testing service addresses business needs by ensuring compliance with regulatory requirements, preventing product contamination, and maintaining customer trust.

    Consequences of Not Performing the Test

    Failure to conduct this test can result in:

  • Product contamination and foodborne illnesses
  • Regulatory non-compliance and fines
  • Loss of customer confidence and market share
  • Industries Requiring This Testing

    This testing service is essential for various industries, including:

  • Food processing
  • Pharmaceutical manufacturing
  • Cosmetics production
  • Animal feed production
  • Risk Factors and Safety Implications

    The presence of microorganisms in food products poses significant health risks to consumers. Regular testing ensures the safety and reliability of these products.

    Quality Assurance and Quality Control Aspects

    Eurolabs laboratory follows a strict quality control protocol, including:

  • Validation and calibration of equipment
  • Standard operating procedures for sample preparation and testing
  • Regular internal audits and proficiency testing
  • Step-by-Step Explanation of the Test

    The FDA BAM Chapter 3 Aerobic Plate Count for Food and Supplements test involves:

    1. Sample preparation

    2. Inoculation of agar plates

    3. Incubation at optimal temperature

    4. Colony counting and enumeration

    Testing Equipment and Instruments Used

    Eurolabs state-of-the-art laboratory uses advanced equipment, including:

  • Automated colony counters
  • Environmental control chambers for incubation
  • Precision instruments for sample preparation
  • Testing Environment Requirements

    The testing environment must meet specific conditions, including temperature (25C 1C), humidity (30 to 60), and pressure.

    Sample Preparation Procedures

    Sample preparation involves:

  • Homogenization of the sample
  • Serial dilution of the sample
  • Inoculation of agar plates with the diluted sample
  • Testing Parameters and Conditions

    The test is conducted under specific conditions, including:

  • Incubation temperature: 30C 1C
  • Incubation time: 48-72 hours
  • Colony counting method: Automated colony counter
  • Measurement and Analysis Methods

    Colony enumeration is performed using automated colony counters.

    Calibration and Validation Procedures

    Eurolabs laboratory follows strict calibration and validation procedures to ensure accuracy and precision of the testing process.

    Quality Control Measures During Testing

    The laboratory maintains a quality control protocol, including:

  • Regular internal audits
  • Proficiency testing with certified reference materials
  • Data Collection and Recording Procedures

    Test results are recorded and stored electronically in accordance with regulatory requirements.

    Report Format and Structure

    Test reports are formatted according to the FDA BAM Chapter 3 Aerobic Plate Count for Food and Supplements guidelines, including:

  • Sample identification
  • Testing parameters and conditions
  • Results and conclusions
  • Results Interpretation

    Results are interpreted according to established criteria, including:

  • Colony count per milliliter
  • Presence or absence of specified microorganisms
  • Conclusion

    The FDA BAM Chapter 3 Aerobic Plate Count for Food and Supplements testing service is essential for ensuring the safety and reliability of food products. Eurolabs laboratory provides accurate and reliable results, adhering to international and national standards.

    Why Choose Eurolab?

    Eurolab offers:

  • State-of-the-art laboratory facilities
  • Experienced staff with expertise in microbiological testing
  • Compliance with regulatory requirements
  • Choose Eurolab for your FDA BAM Chapter 3 Aerobic Plate Count for Food and Supplements testing needs.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

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