Contract development and manufacturing company Vetter has announced that the company’s new filling line at its Ravensburg Vetter South facility has been validated completely and ready for cGMP filling.
The line, which currently fills 1ml standard-format syringes, has a capacity ranging from mid to large-volume batch sizes, with a maximum filling speed of 800 pre-sterilized syringes per minute.
According to the company, the commercial line has been designed to exceed cGMP requirements and features new technologies that improve safety.
Highlights of the line include minimal human contact, fully automated transfer of sterile packed tubs from preparation room to Class-A cleanroom and throughout the filling process.
The line uses Restricted Access Barrier Systems (RABS), a spray disinfection tunnel for bagged tubs, optimized personnel and material flows and one-way design to minimize potential for product mix-up and contamination risk.
Vetter managing director Peter Soelkner said the company continues to expand its prefilled-syringe capabilities with its launch of the new filling line.
"Whether our customers require small-batch clinical fills or high-volume commercial fills, we can accommodate their needs," Soelkner said.
The line consists of an end-to-end track-and-trace system with integrated scanners and printers, optimized routing that minimizes the distances between the compounding area and filling station, and 100% in-line control of syringe closures using a 3-D scanner before filling.
