High Capacity Sterile Filling Line Is a Masterpiece of Sophistication

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It starts and ends with safety

The star feature of the machine is the customized conveyor system which was only incorporated into the planning in early December 2009, i.e. when the design had already been signed off and the isolator was already at the planning stage as well. Even after the event, it is a situation that still brings the project manager out in a cold sweat. The clever part is that each vial is individually drawn into the filling & closing machine by pneumatic means and read by a sensor. From this point onward, the vial can be identified and traced across the entire process. At the end, a 2D data matrix code ensures that the vial is assigned to the correct batch.

“The customer expects a reduction in rejection rates from the Track & Trace System,” says Wieland, based on the capacity of the system to attribute reject products to specific process steps and therefore allow the respective process steps to be optimized. The spoke wheels of the conveyor system may look like classic car parts but the design is deliberate with their minimal aerodynamic drag and the need for a particulate-free environment. In addition to this, the delicate design of the vial holders is best suited for transport by air conveyor in the filling section.

As the filling process involves extremely costly medicines, in-process monitoring has also been optimized. Two electronically controlled precision scales calculate the effective filling quantity by determining the tare weight prior to dosing and the gross weight after the dosing process. The net weight forms the basis for electronic monitoring of the amounts dispensed, which corrects automatically to the target value when required. A record with statistical evaluation is created of all the objects checked by the in-process monitoring system. The system works with a four percent check rate for this line, which Wieland believes is currently unbeatable: “I am not aware of any higher IPC rates currently on offer.”

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