Testing is a key component for properly manufacturing and labeling quality products, even more so for probiotic products. In working with probiotic ingredients the testing is more critical because probiotics are extremely sensitive to heat and humidity. Ensuring quality products requires accurate and consistent testing.
Probiotic enumeration (the process of verifying the number of live colony-forming units or CFUs), like many microbiology methods, includes procedures for diluting the sample so the final dilution plate is in a readable range of 25-250 colonies. Since most probiotic formulas have specifications in the millions or billions of cfu/g, the only way to verify these large counts is to have microbiology plates that are diluted to 10-9, 10-10 or higher.
Testing should always start with verifying the raw material potency, then checking the blend uniformity and finally, ensuring the finished product meets label claims. If the product is going to be labeled with an expiration date, then one additional step is required— shelf-life verification or stability testing.
Stability testing is vital for probiotic products because they can lose potency more quickly than other dietary supplement ingredients, due to the sensitive nature of the bacteria. Probiotic activity, measured in colony forming units (CFU), declines when exposed to heat and humidity, therefore special handling and storage is required to preserve the activity. As raw materials or finished products age, periodic verification of the potency is necessary. This is a few of the reasons stability testing is so important for probiotic products.
The goal with stability testing is to ensure the full label claim is met all the way through the expiration date. Often, overages in the formulation are needed to account for the normal loss of good bacteria over time. Testing at periodic intervals, such as every three to six months will provide the data needed to label the expiration date with assurance. There are guidelines available to plan your stability study and SORA Labs can help execute that plan with ease. Don’t let probiotic viability become a headache—let us quote your project today!