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.
Posted by Dr. Tim Sandle
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