Bioburden Testing

There are many different methods to performing quality control tests on new medical and pharmaceutical products. These tests are used for bacterial identification, harmful side effects, and to determine if new products comply with the various regulations outlined by different organizations. Bioburden testing, also known as a sterilization test, is one of these methods. One of the requirements of new products is that the microbial levels used while manufacturing, processing, and handling them are strictly controlled, and product sterility tests ensure and report this fact. Testing both the raw material and the end product using various methods like dose audit studies helps companies determine if their items are in line with guidelines and are safe for use.

Bioburden and Product Sterility Tests

Bioburden is the measurement indicating the amount of microorganisms that contaminate an object. It's measured in colony forming units per gram, or CFU. Bioburden testing ensures that the number of CFU in a final product does not exceed the amount of CFU in an un-processed bulk action limit. This limit is enforced by the FDA and other groups and is used to decide whether or not a product can be sold on the market. Product sterility tests are also performed on the product in bulk in addition to on the amount of the product that will be sold to the customer.

Dose Audit Studies and Other Tests

There are a number of different tests that can be used for biological indicator testing. They include tests using the following:

• Ethylene oxide
• Dose audit studies
• Various tests using radiation
• Other tests

All of these are identified and listed under the FDA's guidelines, and all pharmaceutical products on the market are required to comply with all of these tests. If you hear of a product not conforming to one of these biological tests, don't use it--it may contain harmful microbiological organisms. For more information, contact us today.