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fda-bam-chapter-7-staphylococcus-aureus-detection
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 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli 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 7 Staphylococcus aureus Detection Testing Services Provided by Eurolab

Introduction

Staphylococcus aureus (S. aureus) is a bacterium that can cause a range of infections, from mild skin conditions to life-threatening diseases such as sepsis and meningitis. The detection of S. aureus in food products, water, and environmental samples is essential to ensure public health safety. In this article, we will provide an in-depth guide to the FDA BAM Chapter 7 Staphylococcus aureus Detection testing services provided by Eurolab.

Standard-Related Information

The detection of S. aureus is governed by various international and national standards, including:

  • ISO 7899-2:1998: Microbiology - Horizontal method for the detection of Staphylococcus aureus using the test for coagulase

  • ASTM E2315-04(2011): Standard Practice for Detection and Quantitation of Bacteria in Foods by Using Selective Agar Mediums

  • EN ISO 10524-2:2008: Microbiology - Horizontal method for the detection of Staphylococcus aureus using the test for coagulase

    • These standards outline the principles, methods, and procedures for detecting S. aureus in various samples. The EUROLAB laboratory adheres to these standards and ensures that all testing is conducted in accordance with regulatory requirements.

    Legal and Regulatory Framework

    The detection of S. aureus is regulated by various international and national laws and regulations, including:

  • FDA BAM Chapter 7: Staphylococcus aureus Detection

  • EU Regulation (EC) No 2073/2005: Microbiological criteria for foodstuffs

  • US FDA 21 CFR Part 110: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Food

    • These regulations outline the requirements for detecting S. aureus in various samples and ensure that all testing is conducted to a high standard.

    Standard Requirements and Needs

    The detection of S. aureus is essential to ensure public health safety and prevent contamination of food products and water supplies. This test is required by:

  • Food manufacturers: To detect and prevent contamination of their products

  • Water treatment plants: To ensure the safety of drinking water

  • Environmental monitoring agencies: To detect and monitor S. aureus in environmental samples

    • The consequences of not performing this test can be severe, including:

  • Foodborne illnesses: Contamination of food products with S. aureus can lead to foodborne illnesses, which can have serious health implications.

  • Economic losses: Failure to detect and prevent contamination can result in economic losses for businesses.

    • Test Conditions and Methodology

    The detection of S. aureus is conducted using a selective agar medium (SA). The procedure involves:

    1. Sample preparation: The sample is prepared by suspending it in a suitable buffer solution.

    2. Inoculation: A small volume of the sample suspension is inoculated onto the selective agar medium.

    3. Incubation: The plate is incubated at 37C for 24-48 hours to allow the bacteria to grow.

    4. Observation: The plate is observed for the presence of S. aureus colonies.

    Test Reporting and Documentation

    The results of the test are documented and reported in a standard format, which includes:

  • Sample identification: Identification of the sample and the date of testing

  • Results: Presence or absence of S. aureus

  • Interpretation: Interpretation of the results in accordance with regulatory requirements

    • Why This Test Should Be Performed

    The detection of S. aureus is essential to ensure public health safety and prevent contamination of food products and water supplies. The benefits of performing this test include:

  • Risk assessment and mitigation: Detection of S. aureus allows for risk assessment and mitigation, which can help prevent contamination.

  • Quality assurance and compliance: Compliance with regulatory requirements ensures that businesses operate safely and responsibly.

  • Competitive advantages: Businesses that detect and prevent contamination are more likely to gain a competitive advantage in the market.

    • Why Eurolab Should Provide This Service

    Eurolab is uniquely qualified to provide this service due to its:

  • Expertise and experience: Eurolab has extensive expertise and experience in detecting S. aureus.

  • State-of-the-art equipment and facilities: Eurolab operates state-of-the-art equipment and facilities that ensure accurate and reliable results.

  • Qualified and certified personnel: Eurolabs personnel are qualified, trained, and certified to conduct this test.

    • Conclusion

    The detection of Staphylococcus aureus is essential to ensure public health safety and prevent contamination of food products and water supplies. Eurolab provides comprehensive testing services that adhere to international and national standards. By detecting and preventing S. aureus, businesses can operate safely and responsibly while ensuring public health safety.

    References

  • ISO 7899-2:1998: Microbiology - Horizontal method for the detection of Staphylococcus aureus using the test for coagulase

  • ASTM E2315-04(2011): Standard Practice for Detection and Quantitation of Bacteria in Foods by Using Selective Agar Mediums

  • EN ISO 10524-2:2008: Microbiology - Horizontal method for the detection of Staphylococcus aureus using the test for coagulase

  • FDA BAM Chapter 7: Staphylococcus aureus Detection

  • EU Regulation (EC) No 2073/2005: Microbiological criteria for foodstuffs

  • US FDA 21 CFR Part 110: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Food

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