The
presence of endotoxin in sterile pharmaceutical products presents a significant
risk to patients. The primary source of endotoxin is pharmaceutical grade
water, due to the potential for Gram-negative bacteria to be present in the
water system or outlets. The water source of greatest impact is
Water-for-Injections (WFI), because this is used as an ingredient water.
To
examine this issue, Tim Sandle has written a review paper examining three
significant water system endotoxin contamination case studies.
In
any form of pharmaceutical manufacture water is one of the most serious
potential sources of microbiological contamination. Water cannot be totally excluded from sterile
products manufacturing facilities. The
primary focus on endotoxin control in pharmaceutical manufacture is on
controlling it at its source – water. If
endotoxin is not controlled at its source it has the potential to create
difficulties through manufacture to the finished product, potentially leaving
no recourse but rejection. Endotoxin is
practically impossible to remove terminally from pharmaceutical dosage forms.
Well-maintained
and operated water systems should not see endotoxin detected on a regular
basis. Where endotoxin detection occurs, this is typically due to a special
cause event, signifying that something untoward has occurred with the design or
operation of the water system. To illustrate what can sometimes occur, as
providing some learning points, this article presents three cases studies
relating to WFI systems, relating to three different pharmaceutical companies.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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Pharmaceutical Microbiology