Application note: TOC for cleaning validation: swab recoveries of worst-case compounds (feasibility testing)

THE PARENTERAL Drug Association Technical Report No. 49 serves as a resource to help guide the development and evaluation of a cleaning validation programme.

The report highlights that a cleaning validation programme should include elements of design, equipment qualification and continued verification, with key points to consider based on an understanding of the cleaning process itself. This includes understanding critical performance parameters (CPPs) such as temperature, time, cleaning agent concentration and analytical methods such as TOC analysis.