EUROLAB
aoac-200301-testing-for-escherichia-coli-and-coliforms
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 2003.07 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 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

AOAC 2003.01 Testing for Escherichia coli and Coliforms: Laboratory Testing Services by Eurolab

The AOAC 2003.01 method is a widely accepted standard for testing water, wastewater, and other environmental samples for the presence of Escherichia coli (E. coli) and coliform bacteria. The standard is developed and published by the Association of Official Analytical Chemists (AOAC), a leading organization in the field of analytical chemistry.

International Standards

The AOAC 2003.01 method is based on international standards, including:

  • ISO 9308-1:2014, Water quality Detection of intestinal enterococci and Escherichia coli Part 1: Method using a two-stage membrane filter
  • ASTM E2122-16, Standard Test Method for Enumeration of Coliforms in Water by Multiple-Tube Fermentation Technique
  • EN ISO 9308-1:2014, Water quality Detection of intestinal enterococci and Escherichia coli Part 1: Method using a two-stage membrane filter
  • National Standards

    In addition to international standards, national standards also apply to AOAC 2003.01 testing. These include:

  • EU Directive 98/83/EC on the quality of water intended for human consumption
  • US Environmental Protection Agency (EPA) regulations for water quality monitoring
  • Standard Development Organizations

    The AOAC is a leading standard development organization in the field of analytical chemistry. Other organizations involved in developing standards for laboratory testing services include:

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • Evolution of Standards

    Standards evolve over time to reflect advances in technology, changes in regulatory requirements, and improvements in analytical techniques. The AOAC 2003.01 method has undergone revisions to ensure that it remains relevant and accurate.

    Standard Numbers and Scope

    The AOAC 2003.01 method is identified by the following standard numbers:

  • AOAC 2003.01:2018
  • ISO 9308-1:2014
  • ASTM E2122-16
  • The scope of these standards includes testing for E. coli and coliform bacteria in water, wastewater, and other environmental samples.

    Compliance Requirements

    Laboratories must comply with relevant national and international standards when performing AOAC 2003.01 testing. This includes ensuring that equipment, reagents, and personnel meet the required standards.

    Standard-Related Information Summary

    Standard Title Scope

    --- --- ---

    ISO 9308-1:2014 Water quality Detection of intestinal enterococci and Escherichia coli Part 1: Method using a two-stage membrane filter Testing for E. coli and coliform bacteria in water, wastewater, and other environmental samples

    ASTM E2122-16 Standard Test Method for Enumeration of Coliforms in Water by Multiple-Tube Fermentation Technique Testing for coliform bacteria in water, wastewater, and other environmental samples

    EN ISO 9308-1:2014 Water quality Detection of intestinal enterococci and Escherichia coli Part 1: Method using a two-stage membrane filter Testing for E. coli and coliform bacteria in water, wastewater, and other environmental samples

    Why AOAC 2003.01 Testing is Needed

    E. coli and coliform bacteria are indicators of fecal contamination and potential health risks. Testing for these microorganisms is essential to ensure the safety of drinking water, wastewater, and other environmental samples.

    Business and Technical Reasons for Conducting AOAC 2003.01 Testing

    Conducting AOAC 2003.01 testing helps laboratories:

  • Ensure compliance with national and international regulations
  • Maintain quality standards in analytical chemistry
  • Provide accurate results for customer confidence and trust building
  • Support business development through reliable testing services
  • Consequences of Not Performing AOAC 2003.01 Testing

    Not performing AOAC 2003.01 testing can lead to:

  • Non-compliance with regulatory requirements
  • Risk of inaccurate or unreliable test results
  • Potential health risks from contaminated water, wastewater, and other environmental samples
  • Industries and Sectors that Require AOAC 2003.01 Testing

    AOAC 2003.01 testing is required in various industries, including:

  • Drinking water treatment plants
  • Wastewater treatment plants
  • Food processing and manufacturing
  • Pharmaceutical and cosmetics industry
  • Risk Factors and Safety Implications

    E. coli and coliform bacteria pose health risks to humans, animals, and the environment. Testing for these microorganisms is essential to prevent contamination and ensure public safety.

    Standard Requirements and Needs Summary

    Requirement Need

    --- ---

    Compliance with national and international regulations Ensure safety of drinking water, wastewater, and other environmental samples

    Maintenance of quality standards in analytical chemistry Provide accurate results for customer confidence and trust building

    Provision of reliable testing services Support business development through reliable testing services

    Standard Requirements and Needs Summary Table

    Standard Requirement Need

    --- --- ---

    AOAC 2003.01:2018 Compliance with national and international regulations Ensure safety of drinking water, wastewater, and other environmental samples

    ISO 9308-1:2014 Maintenance of quality standards in analytical chemistry Provide accurate results for customer confidence and trust building

    ASTM E2122-16 Provision of reliable testing services Support business development through reliable testing services

    Standard Requirements and Needs Conclusion

    AOAC 2003.01 testing is essential to ensure the safety of drinking water, wastewater, and other environmental samples. Laboratories must comply with relevant national and international standards when performing AOAC 2003.01 testing.

    Standard-Related Information Conclusion

    Standards are essential for ensuring accuracy, reliability, and quality in laboratory testing services. The AOAC 2003.01 method is based on international and national standards, including ISO 9308-1:2014, ASTM E2122-16, and EN ISO 9308-1:2014.

    Standard Requirements and Needs Conclusion

    AOAC 2003.01 testing is essential to ensure the safety of drinking water, wastewater, and other environmental samples. Laboratories must comply with relevant national and international standards when performing AOAC 2003.01 testing.

    Next Section: Standard Requirements and Needs

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