SterStar system: continuous sterile transfer by e-beam

Abstract

The choice of isolator technology and the use of tubs in a filling line necessitate sterilization of the outer surface of the tub, provided that the inside has been sterilized by another method, prior to entry into the sterile zone. It is a well-known fact that there is a relation between the radiation dose applied to the product and the log reduction of bacteria activity. Electron beam generation technique for sterilization is also well known and widely used in the field of sterilization, e.g. of non-woven materials. This paper describes the electron sterilization transfer system developed by Linac Technologies for pharmaceutical filling lines. The system, called SterStar, takes charge of products placed at the entrance by an operator, and directs the flow through the machine, ejecting into the filling isolator tubs which have been completely surface sterilized. This entirely automatic system can supply the filling machine in terms of throughput. The sterilization heads have a capacity well beyond the maximum performances of the filling line. A number of other applications of this sterilization unit are mentioned.