Thursday, 21 January 2016

Biocontamination Control in Pharmaceutical Production

Merck have provided a guide to “Biocontamination Control in Pharmaceutical Production.” This comes in the form of a white paper.

The introduction reads:

“Biocontamination refers to biological contamination of products by bacteria and/or fungi, as well as the toxic by-products of these microorganisms, such as endotoxin and mycotoxins from Gram-negative bacteria and fungi, respectively. When designing a biocontamination control strategy, which is based on the manufacturing process, there are three components to take into consideration, each of which requires risk assessment: 1) designing process systems to avoid contamination; 2) monitoring process systems to detect contamination; and 3) reacting to contamination events and putting proactive measures in place. The design of process systems is where maximal effort should be placed.”

The paper is written by Tim Sandle, Tony Ancrum, and Anne Connors.

The paper can be accessed here.

 Posted by Dr. Tim Sandle