How are microbial limits and objectionable microorganisms determined?
A. In determining the appropriate microbial limit, the USP Analytical Microbiology Expert Committee considers such matters as the route of administration, the form of the product, and the source material. For example, it is never appropriate to have any microorganisms in a product intended for injection intravenously. Therefore, you will never see a microbial limit listed for such products. Instead, those products must meet the test for Sterility . Other products may be in a form possessing extremely low water activity, such that microbial growth could not occur. You may not see microbial limits provided for some of those products. Many other products, such as those intended for oral administration, will have limits provided. Those limits are selected such that the risk of harm to the consumer is extremely low, while being reasonable from a manufacturing and quality control perspective. Products from botanical sources may have higher limits due to the larger bioburden associated with t
