What Counts? Establishing a Bioburden Strategy for a New Pharmaceutical Product

 

For both sterile and non-sterile manufacturing, bioburden control as evidenced by microbial counts is especially important in relation to the quality of the finished product and as an indicator of process control. Samples are drawn from intermediate product at defined stages (ideally based on risk assessment) and these allow for the microbial levels to be tracked from upstream processing to downstream processing (with an expectation that the microbial levels decrease, or at least remain unchanged provided they are below an acceptable action level).

 

 

Sandle, T. (2022) What Counts? Establishing a Bioburden Strategy for a New Pharmaceutical Product, American Pharmaceutical Review, 25 (6): 62-67

 

See: https://www.americanpharmaceuticalreview.com/Featured-Articles/590786-What-Counts-Establishing-a-Bioburden-Strategy-for-a-New-Pharmaceutical-Product/

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)