The
majority of contamination in a pharmaceutical facility, presuming that the air
handling system is functioning as designed, that water systems are low in
bioburden and are not leaking, and there is good control of in-coming
materials, will derive from people. It follows that an effective contamination
control strategy will focus on the control of operators. Control extends to
behaviors, gowning and having the correct equipment, and this will be supported
by periodic qualifications and underpinned by audits.
In
relation to this, Tim Sandle has written a new article:
“This
article addresses some of the key concerns relating to operators within
cleanrooms, in the context of the risk operators pose in terms of microbial
contamination. The article is divided into three sections. The first part looks
at means to improve operator behaviors, the second part looks at how regular
reviews by plant microbiologists or quality assurance staff can help to
reinforce these behaviors, and the third part considers the idea of having
‘environmental control champions’ within the production facility.”
The
reference is:
Sandle,
T. (2019) Focusing on the Operator: Reducing Facility Environmental
Contamination, American Pharmaceutical
Review, 22 (3): 12-17
No comments:
Post a comment
Pharmaceutical Microbiology Resources