The Impact of Automation on Aseptic Processing

By the late 1970s, there was a greater awareness emerging regarding the impact of gowned operators in aseptic processing, and some industry scientists began to state this fact clearly and publicly. A 1988 article entitled, "A Review of Current Technology in Parenteral Manufacturing," written by members of the FDA research committee, stated forcefully that the principal contamination concern in aseptic processing was personnel-related contamination. This article noted that emerging technologies were already mitigating contamination risk. It was in that same decade that the authors became fully aware of the impact of personnel-borne contamination and took part in projects in which the processing equipment was specifically designed to mitigate that risk through the application of automation. This article provides only a glimpse into the history of automation in aseptic processing and its development during the past three decades. The future of aseptic technology lies in the continued implementation of automation with the ultimate goal being the complete elimination of interventions altogether.