Probiotic Enumeration
Here is your updated content with Unicorn Analytical replacing the previous company name and keeping the style consistent with your other revisions:
Probiotic Enumeration
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 the product contains the labeled amount and performs as intended. It also enables measurement of product stability over time, as viable microorganism counts can decline due to storage conditions, formulation, and shelf life. Probiotic organisms can be sensitive to oxygen, temperature, light, and other environmental factors that significantly affect the number of living cells remaining in the product.
Probiotic enumeration is specifically required in Health Canada's Quality of Natural Health Products Guide (Appendix 4). In the United States, probiotics fall under the quality requirements of 21 CFR 111 GMPs for dietary supplements, which state that manufacturers “must establish product specifications for the identity, purity, strength, and composition” of the finished product. Enumeration verifies that each lot contains the number of active cells claimed on the label.
At Unicorn Analytical, we perform probiotic enumeration in our microbiology department using a range of recognized methods, including USP <64>, USP microbe-specific monographs (e.g., Bacillus coagulans), CMMEF Ch. 20, internal validated methods, and client-provided methods. Because different probiotic organisms have unique cultural requirements, we collaborate closely with clients to determine the best approach for their specific strains and formulations. This is increasingly important as more novel probiotic organisms and complex multi-strain blends enter the market.
Contact Unicorn Analytical today to discuss how we can support your probiotic enumeration needs!
If you want, I can also format this for a webpage layout, add headings, or create an SEO-optimized version.