ABSTRACT
Grouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime. Though regulatory [1] [2] and industry guidelines [3] support the practice and provide guidance, there is a clear requirement for scientific justification.
Common industry practice is to either avoid grouping because of perceived risk or base the grouping only on a few physical characteristics (i.e., surface area and vessel size).
Equipment grouping should include equipment geometry and complexity; internal equipment components; piping diameter; and critical cleaning parameters.
The following discussion will explore concepts, considerations, and suggestions for cleaning validation (CV) equipment grouping.
