Process Hold Times for Microbial Risks

A new paper about the microbiological risks of holding product at different stages during the pharmaceutical manufacturing process has been issued. The abstract runs:

This paper has discusses the implications of the process hold times on microbial growth during pharmaceutical manufacturing. Microbiological risk exists -- especially with biological products. If microbial contamination occurs where microorganisms enter a product in sufficient numbers and if the process hold time is long enough, the process hold time may be problematic.

The reference is:

Sandle, T. (2015) Assessing Process Hold Times for Microbial Risks: Bioburden and Endotoxin, Journal of GXP Compliance, Vol. 19, Issue 3, Oct 2015, pp1-9

For further details, please contact Tim Sandle

Posted by Tim Sandle