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 at Whitehouse Labs by clicking below