Sunday, 17 March 2013

Why The Swab Matters In Cleaning Validation

Cross-contamination with extraneous residues of any kind presents a safety risk to patients consuming the drug product. To explore the assessment of this risk and in a discussion on the importance of methods of detection for cleaning validation, Sandeep Kalelkar has written a comprehensive overview for Controlled Environments magazine.

An excerpt reads:

“Swabbing and rinsing are the two most common techniques used for sampling of such cleaned surfaces. Swabbing is a direct surface sampling method, while rinsing is an indirect method. In practice, physical access to surfaces and parts of equipment to be cleaned tends to drive the choice of sampling method. For example, swabbing would work particularly well in more restricted work areas such as isolators, hoods, and accessible corners of equipment, while rinsing would work best in pipes and longer tubes. In general, a combination of both is most desirable in order to accomplish the most comprehensive coverage of surfaces to be cleaned.”

To read the articles see Controlled Environments.

Posted by Tim Sandle