Risk Assessment for Vial Filling & Stoppering Machine

The Vial Filling & Stoppering machine shall be an automatic machine with preferably 8 different stations to fill 8 vials at a time and stoppering the filled vials.

The sterilized and depyrogenated vials shall be transported from the upstream depyrogenation tunnel into the filling and stoppering machine via infeed turn table, infeed transfer system and star wheels.

From the infeed star wheel the vials shall be handed over to infeed conveyor, which shall transport the vials through the filling and stoppering machine.

IPC tare weighing and gross weighing stations with star wheels shall be provided before and after filling, for checking weight of product filled. Pre and post –gassing station for vials shall also be provided before and after filling.

At the filling station, the vials shall be filled with required volume of product solution, using rotary piston pumps. After IPC gross weighing station, the vials shall be transported via the conveying system to the stopper inserting station. At the stopper inserting station the vials shall be inserted with stoppers and the stoppers shall be pressed down. The machine shall be suitable for both type of stoppering i.e. half stoppering (for products to be lyophilized) and full stoppering (for liquid filled product). During stopper inserting also, the vials shall be gassed with inert gas. The vials shall then be checked for stopper presence. Faulty detected vials shall be rejected in the reject station via reject star wheel.