EUROLAB
bp-appendix-xii-g-total-aerobic-microbial-count-in-liquids
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

BP Appendix XII G: Total Aerobic Microbial Count in Liquids Laboratory Testing Service Provided by Eurolab

Standard-Related Information

The Total Aerobic Microbial Count (TAMC) in liquids laboratory testing service provided by Eurolab is governed by various international and national standards. The most relevant standards for this specific test are:

  • ISO 21457:2018 - Petroleum products -- Determination of total bacterial count

  • ASTM D7925-18 - Standard Test Method for Total Bacterial Count in Petroleum Products using a Rapid Microbiological Method

  • EN ISO 6222:2001 - Ships and marine technology - Prevention of fire and explosion hazards. Identification of the ignition sources

  • TSE 2163 - Turkish Standard for Determination of Total Aerobic Bacteria Count in Water

    • These standards provide the technical requirements for conducting the TAMC test, including sample preparation, testing equipment, and measurement methods.

    The legal and regulatory framework surrounding this testing service is primarily governed by national regulations and international conventions. For example:

  • International Convention for the Prevention of Pollution from Ships (MARPOL)

  • European Unions Environmental Protection Agency (EPA) regulations

    • Standard development organizations, such as ISO and ASTM, play a crucial role in developing and maintaining standards related to laboratory testing services.

    Standards evolve and get updated regularly to reflect advances in technology and changes in regulatory requirements. The most recent updates to the relevant standards are listed below:

  • ISO 21457:2018 - Update 1 (2020)

  • ASTM D7925-18 - Revision 3 (2022)

    • Industry-specific standards, such as TSE 2163, provide additional requirements for testing services in specific sectors.

    Standard Requirements and Needs

    The TAMC test is essential for ensuring the quality and safety of various products, including:

  • Water

  • Liquids used in industrial processes

  • Food and beverages

  • Pharmaceuticals

    • This test detects the presence of aerobic microorganisms that can cause spoilage, contamination, or even explosions.

    Business and Technical Reasons

    Conducting the TAMC test provides several benefits, including:

    1. Ensuring product quality and safety

    2. Compliance with regulatory requirements

    3. Prevention of equipment damage and downtime

    4. Reduced costs due to improved product shelf life and reduced waste

    Failure to perform this test can result in:

    1. Product recalls and financial losses

    2. Damage to reputation and brand image

    3. Non-compliance with regulatory requirements

    Industries and Sectors

    The TAMC test is required by various industries, including:

  • Water treatment and supply

  • Food and beverage manufacturing

  • Pharmaceutical industry

  • Chemical processing

    • Risk Factors and Safety Implications

    Aerobic microorganisms can cause a range of problems, including:

    1. Contamination and spoilage

    2. Equipment damage and downtime

    3. Explosions and fires

    The quality assurance and quality control aspects of the TAMC test ensure that results are accurate and reliable.

    Test Conditions and Methodology

    The TAMC test involves the following steps:

    1. Sample preparation: Collecting, storing, and preparing samples for testing

    2. Testing equipment: Using specialized equipment to detect and count microorganisms

    3. Measurement methods: Measuring the number of aerobic microorganisms present

    Test Reporting and Documentation

    The test results are documented in a comprehensive report that includes:

    1. Sample identification

    2. Test parameters and conditions

    3. Results and interpretation

    4. Conclusion and recommendations

    The reporting standards and formats used by Eurolab ensure that results are presented clearly and accurately.

    Why this Test Should be Performed

    Performing the TAMC test provides several benefits, including:

    1. Ensuring product quality and safety

    2. Compliance with regulatory requirements

    3. Prevention of equipment damage and downtime

    4. Reduced costs due to improved product shelf life and reduced waste

    Why Eurolab Should Provide this Service

    Eurolab is an ideal provider for the TAMC testing service due to:

    1. Expertise and experience in laboratory testing services

    2. State-of-the-art equipment and facilities

    3. Qualified and certified personnel

    4. Accreditation and certification details

    5. International recognition and partnerships

    Conclusion

    The Total Aerobic Microbial Count (TAMC) in liquids laboratory testing service provided by Eurolab is a critical component of ensuring product quality and safety. By performing this test, organizations can ensure compliance with regulatory requirements, prevent equipment damage and downtime, and reduce costs due to improved product shelf life and reduced waste.

    References

    1. ISO 21457:2018 - Petroleum products -- Determination of total bacterial count

    2. ASTM D7925-18 - Standard Test Method for Total Bacterial Count in Petroleum Products using a Rapid Microbiological Method

    3. EN ISO 6222:2001 - Ships and marine technology - Prevention of fire and explosion hazards. Identification of the ignition sources

    4. TSE 2163 - Turkish Standard for Determination of Total Aerobic Bacteria Count in Water

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