Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility

Introducing new compounds into a pharmaceutical manufacturing facility can pose ongoing challenges to a facility’s cleaning validation program. Some discussions have described how a cleaning validation program can be conducted (1–2). Several programs have used a worst-case approach to validating a cleaning program (3–8).Approaches for determining the worstcase soil have included evaluating which residue was the last to rinse from the manufacturing vessel (3), using a product grouping strategy (4–6), assessing the relative toxicological properties of the formulation components (7), and relying on the practical cleaning experience of the formulators and equipment cleaners (8). Once a worst-case soil has been validated, however, introducing a new compound requires determining whether this compound is a new worst case.

Author(s):

Richard J. Forsyth and Vincent Van Nostrand,

Journal:

Pharmaceutical Technology, Apr 2, 2005