Why it’s time to focus on the cleanroom operator

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

For further details, contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology