R.J. Forsyth's scientific contributions

Publication (1)

Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program, if hold times are validated under properly defined and controlled conditions, it is possible that monitoring either or both hold times may not be necessary.


... Typically, the washing process in the pharmaceutical plant begins immediately after the production batch. The postponement of several days can make more efficient use of working time and lead to cost reductions, but the residuals of the produced material, however, may become more difficult removable after the delay [5]. Dirty-hold time is part of the cleaning validation process from the beginning, but often overlooked [6]. ...