What is Total Viable Count ? 

Total Viable Count testing is a process of quality control which permits to measure the total number of viable microorganisms (total microbial count) of a product at different stages of production (raw materials, components and final products).

The contaminants may originate from various sources, the environment in which the product is processed or manufactured, the personnel who process or manufacture it, the machinery and tools used during processing, and the raw materials or components used.

Total Viable Count analysis is often part of routine testing to ensure the safety, quality and regulatory compliance of each batch of manufactured products.

Total Viable Count testing is usually performed in these industries.

• For medical devices
• pharmaceuticals products
• Food
• Beverage
• Water
• Packaging
• Raw materials
• Cosmetics.

Standard in Total Viable Count Analyses

The standards that govern the bioburden testing depend on the type of product concerned.

• For cosmetics and pharmaceuticals, Total Viable Count is performed according to USP chapter <61> and results are given for TAMC (Total Aerobic Microbial Count) and TYMC (Total Yeasts and Molds Count),
• For terminally sterilized medical devices, according to ISO 11737-1.
• For water, it is performed according to ISO 6222 or APHA method 9215.

The bioburden quantification is expressed in colony forming unit (CFU) and each of these standards indicates a microbial limit (a maximum CFU per volume or weight unit) not to be exceeded in order to guarantee the quality of the final product.

For example, in the case of oral and topical non-sterile pharmaceutical products, the Total Aerobic Microbial Count (TAMC) cannot exceed 1,000 CFU/g or mL, and the Total Yeast and Mold Count (TYMC) cannot exceed 100 CFU/g or mL.

For potable water analysis, there is no universal agreement on the acceptable concentration of organisms in drinking water. The most common allowable bacterial numbers used by health departments, water-supply agencies, and local jurisdictions vary from 100 to 500 CFU per milliliter.

Total Viable Count Testing for a Better Quality Control Monitoring

Total Viable Count testing helps to ensure that products and processes are clean enough to have a contamination free environment. Culture and incubation is still the gold standard for enumeration and thanks to Diamidex’s MICA Highlight Solution, you can now have faster results and automated enumerations of Total Microbial Count.