The line’s capacity ranges from mid- to large-volume batch sizes, with a maximum filling speed of 800 pre-sterilized syringes per minute. The line currently fills 1ml standard-format syringes, with additional formats to be added in the near and long terms.
Minimal human contact to enhance safety, with use of use of Restricted Access Barrier Systems (RABS), and fully automated transfer of sterile packed tubs from preparation room to Class-A cleanroom and throughout the filling process. A novel approach to zonal transition when moving tubs to higher cleanroom classes is used.
Optimized personnel and material flows with one-way design to minimize potential for product mix-up and contamination risk.
Advanced track and trace: an end-to-end track-and-trace system with integrated scanners and printers, including automated disposal of rejects and sample removal following the filling process
Techniques and technology to maximize API yield include optimized routing that shortens the distances between the compounding area and filling station. Also, 100-percent, fully automated in-line control of syringe closures using a 3-D scanner prior to filling, to minimize API loss and reduce risk of contamination, and in-line monitoring of filling quantities using an automatic weighing system.