Probiotic enumeration is the process of quantifying the number of viable microorganisms, such as bacteria or yeast, in a probiotic product. This is typically done by counting colony-forming units (CFUs) through culturing techniques.
Probiotic enumeration allows manufacturers to verify the quantity of active microorganisms in their product, ensuring that the product contains the labeled amount and that it is effective. It also allows manufacturers to measure the stability of the product over time, as the number of viable microorganisms can decline due to factors such as storage conditions and shelf life. Probiotic active organisms can be sensitive to oxygen, temperature, light and other factors that can substantially impact the number of living cells in the product over time.
Probiotic enumeration is specifically called for in Health Canada’s Quality of Natural Health Products Guide, Appendix 4. In USA, probiotics fall under the quality requirements set out in 21 CFR 111 GMPs for dietary supplements which states manufacturers “must establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement.” Probiotic enumeration allows manufacturers to verify that the lot of product contains the number of active cells claimed on their supplement’s label.
Vivariant performs probiotic enumeration in our microbiology department. Methods include USP <64>, USP microbe-specific monographs such as Bacillus coagulans, CMMEF Ch. 20, internal, and client-provided methods. Different probiotic organisms have different cultural needs so we work with clients to find the best fit for their products. Today this is important as more and more probiotic organisms are being brought into the industry and more complex inter-generic product blends are being produced.
Contact us today to discuss how we can help with your probiotic enumeration project!