It is critical to determine the amount of residue that
remains on product contact surfaces after cleaning to
assess whether the equipment is safe for use in subsequent
pharmaceutical manufacturing. This is accomplished
through the successful execution of cleaning
validation protocols, which are mandated by various
government regulations.
There are two types of sampling techniques commonly
used in cleaning validation protocols: direct such as
visual, swabbing, or wiping and indirect such as rinsing.
This paper focuses on rinse sampling using total organic
carbon analysis as the method of detection. The article
will describe two different approaches to determine
percent recovery values when accounting for volatile
components in product formulations