Total Aerobic Microbial Count (TAMC)

USP Microbial count testing is a product safety test found in chapter 61 of the United States Pharmacopoeia.

It is recommended for use in cosmetics and personal care products, as well as pharmaceuticals, by the US Food and Drug Administration (FDA) to ensure that the preparation of a product complies with pre-established specifications for microbiological quality.

The USP test method is the complete quantitative analysis of a product to detect the total aerobic microbial count (TAMC) and total yeast and mold count (TYMC) present in the sample. This test method also includes neutralization and recovery verification using specific microorganisms. In this way, the methods used to determine the presence of these microorganisms become appropriate for each product.

Similar to the aerobic plate count test, USP determines the number of colony-forming units present in a product, but this method also includes verification of neutralization and recovery using specific microorganisms. Neutralization and recoverability analysis is a check used to demonstrate that any antimicrobial substance in the product will effectively prevent it from killing microorganisms that may have contaminated the product during production.

Microbial limit testing is performed to determine whether pharmaceutical products comply with established standards for microbial quality. In most cases, microbial limit testing includes:

• Total aerobic microbial count (TAMC). In this step, the total number of aerobic organisms is determined, which is an important indicator for measuring the hygienic quality of drugs.
• Total combined yeast and mold count (TYMC). In this step, the number of contaminated live bacteria (yeast and mold) in the unit mass, volume or area of ​​the drug is determined. The measurement result is used to evaluate the degree of contamination of the drug and the sanitary quality of the drug.
• Screening test for specified microorganisms. In non-sterile pharmaceutical products, the number of microorganisms is limited, while pathogenic bacteria are not allowed. There are many types of pathogenic bacteria and it is not possible to detect them individually. Therefore, in drug production practice, by evaluating the contamination possibilities, potential hazards, stability and operability of the detection method, pseudomonas aeruginosa, escherichia coli, staphylococcus aureus, salmonella and similar bacteria are tested to ensure the safety of the drug.

However, it is not necessary to test all of these bacteria for a particular drug formulation. To decide which type of pathogenic bacteria to test, researchers consider factors such as the drug's dosage form, route of administration, raw material source, or medical purpose.

Microbial limit testing is important to determine whether the drug is contaminated or the degree of contamination and to control the quality of the drugs. Microorganisms are widely found in nature, and medicines are easily contaminated during production, transportation and storage. Under favorable conditions, microorganisms can grow and multiply rapidly, leading to drug degradation and poor quality.

Thanks to the drug microbiological limit test, it is possible to understand whether the drug is contaminated and the degree of contamination, to find the source of contamination and to adopt appropriate control methods to ensure the quality of the drug.

Counting for total aerobic bacteria is also important in the food industry. Accurate counting is very important because most foods are not sterile and have a certain number of bacteria in them. With this test, manufacturers estimate the shelf life of the product. If there is any microbiological quality control, most foods produced release food up to a certain limit of total aerobic bacteria. Neither overestimating nor underestimating is desirable.

Among the numerous testing, measurement, analysis and evaluation studies provided to businesses by our organization, there are also total aerobic microbial count (TAMC) services.