High Risk from Human Intervention during Aseptic Filling


It is well known that human intervention increases the risk of finished product sterility failure during the aseptic filling process. For traditional aseptic filling lines using RABS, human intervention is often required, such as adjusting conveyor belts, turntables, vibrating bowls, star wheels through gloves. Viable or non-viable particles may be introduced into the finished product during human intervention.

To minimize the risks, isolators have been widely adopted in recent years. However, due to the inherent design of the filling machine, the above risk of human intervention still exists if the glove breaks during the aseptic filling process.

To further eliminate the risk of human intervention, Amaran Biotech features the Cytiva SA25 Aseptic Filling Workcell, a redesigned robotically integrated gloveless isolator that utilizes semiconductor robots to transfer single-use container-closures in tub/nest within the workcell during the aseptic filling. By leveraging this advanced technology, our customers’ products can be manufactured without the risk of human intervention.