Designing and Quality Aspects of Aseptic Process Simulation

Abstract

Aseptic process simulation is a crucial validation technique carried out before a new product or aseptic process is introduced in the facility and also to prove on regular intervals that the existing manufacturing operations are carried out in a state of aseptic conditions. Aseptic process simulation involves conducting aseptic production using a sterile growth medium instead of actual drug solution and excipients. The processes involved in aseptic validation include the identification of process mechanisms, variables and control methods and that also include product, component, and sterilization of equipment, sanitary facilities, environmental checks and staff training on gowning procedure. This review addresses the nature of the study involved in aseptic process simulation, speed and number of runs, runtime, the atmospheric conditions, line speed, the media used, incubating and analyzing media-filled units, data interpretation, worst-case parameters, interventions, case study on interventions and the regulatory aspects concerned with the simulation.