Validation of a separator CSA8 regarding sterilization for aseptic processes

Abstract A method for the validation of a solid ejectic disk centrifuge is described with respect to sterilizability and aseptic processing. The validation run was carried out in a pilot plant classified as S2, without any additional filter equipment in the ventilating system to fulfill classifications for the particle loading in the surrounding. As a part of the validation a monitoring concept is presented which indicates that the equipment meets the defined functionality (sterilizability). A short overview is given for the different direct microbiological and indirect physical and chemical methods used as monitoring systems. Many aspects of the work described in this paper should be generally valid with respect to the validation of sterilization and aseptic processing. These general aspects generate the possibility for transferring the results to additional equipment that may be based on similar design concepts.