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How to fill a pre-filled syringe, vial or cartridge? There are two basic technological approaches for filling a liquid pharma product into a RTU container: It is differentiated between a automatic sterile filling machine with a Statistical In-Process-Control (IPC) and fillers with a 100% In-Process-Control (IPC). The decisive difference between the two methods is whether and when the objects are lifted out of the tub or nest and weighed.
Other steps like filling or stopper placement with vacuum, gassing of oxygen sensitive products as well as the use of various filling systems (i.e. rotary piston pumps, peristaltic pumps or time-pressure system) can be realized with both types.
For fillers with statistical IPC, the objects can remain in the nest during filling and stoppering. The number of weighing processes can be set via the user interface, the objects are lifted out with robotic arms and weighed before and after filling.
With these pharmaceutical syringe filling machine also suitable for cartridges, the objects remain in the nest after they have been closed and can be inspected after they have been removed from the aseptic area.
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The procedure may be different for a vial. If they are closed with integrated stopper caps, the process is similar to that for a pre-filled syringe and cartridge. However, if they are to be sealed in the traditional way with stoppers and aluminum caps, the vials are lifted out of the nests by a robotic arm and individually fed to the crimping machine.
Automated syringe fillers (as well as vials and cartridges) with 100% IPC are characterized by the fact that all containers to be filled are brought individually into a transport system after the lid and liner have been removed from the tub.
Since the separation is done with a robot arm, this only has a minimal impact on the laminar flow around the objects. Manipulated they can also be weighed individually. With these systems, it is possible to define the filling range even more precisely, since direct adjustment is just as possible as redosing or replacing missing stoppers.
The smartfill feature established by groninger also minimizes product loss when starting up or running empty.
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Filling and closing cartridges