7 Steps For A Reproducible Cycle Development Plan

By Stefan Kleinmann PhD, Matthias Scheu, Christian Fecht, METALL+PLASTIC

Decontamination cycle development takes place between the completed operational qualification and the subsequent process validation. It also determines the parameters for a successful, effective and repeatable decontamination process that complies with the requirements of both regulatory agencies and end users. The PIC/S guide for isolators states that an isolator decontamination cycle using a minimum 6-log spore reduction is often applied (1). During routine operation, pharmaceutical isolators and material transfer chambers use decontamination cycles to yield a theoretical 10- to 12-log spore reduction for additional safety.