We provide microbiological population verification services through the assessment of biological indicators per USP <55>. Biological indicators are used in the validation, performance verification and/or with-use verification of cleaning and sterilization processes, such as steam sterilization, ethylene oxide sterilization and gamma irradiation. They typically contain a high concentration of bacterial endospores that are the most resistant to sterilization and are available in many formats corresponding to their use.
In order to meet the requirements of USP <55>, the population of biological indicators must be verified. This involves processing and/or suspending the indicator in a diluent, diluting it to the countable range and enumerating.
Probiotic Label Claim Verification
Probiotic products are typically labeled with a population concentration. As with nutritional supplements, vitamins and drugs, it is important to ensure that any product contains the specified or labeled range of a therapeutic substance.
The organism or organisms present on the label claim for a probiotic or biological indicator should be identified to ensure purity. Testing for microbial limits will also help ensure purity and safety.
Contact our analytical testing team by clicking below