Validation Of Aseptic Processes
Sterile Products may be broadly classified into two main categories, according to the manner inwhich they are produced: those which are sterilized after the product has been filled and sealed inthe final container(s) (“terminally sterilized” products) and those where the sterilization stage (orstages) takes place is it before or after the bulk product filled in to final container. In this latterinstance, all subsequent processing (typically, the filling and sealing operations) must be conductedaseptically in order to prevent recontamination of the sterilized product. The two most commonpharmaceutical applications of aseptic processing methods are (a) the filling of liquid productsfollowing sterilization by filtration and (b) the filling of previously sterilized bulk powderproducts. An aseptic processing operation should be tested using a microbiological growth medium(media fill) during lyophilized injection formulation, filling, loading, lyophilisation, stoppering, andunloading activities.