Steriline, the well-recognised manufacturer of complete lines for the aseptic processing of injectable products, is receiving visitors at Pharmintech 2022 in Milan, Italy, the international trade show running from 3 to 6 May.
Hosted in the booth (Hall 2P, stand N° B74) of its Italian representative, TechPharma, Steriline is showing its Robotic Nest Filling Machine (RNFM2) equipped with two filling heads and peristaltic pumps.
The RNFM2 is a stand-alone solution developed in response to the request of an Italian producer of veterinary drugs to enlarge its product portfolio adding single-dose glass pre-filled syringes (PFS) to the multidose vials already in production.
The machine is equipped with two manual loading and unloading stations, where an operator inserts tubs previously peeled under a Laminar Air Flow. A robotic arm grabs the nest in the tub containing the empty PFSs and positions it under the two filling heads connected to the peristaltic pumps, which can potentially fill glassware from 0.1 ml to infinite capacity. In addition to the double filling heads, the machine is also equipped with two stoppering heads. Filling and stoppering are performed simultaneously, and once completed, the robotic arm repositions the tub in the nest at the exit station, ready for the operator to withdraw it and transfer it to the secondary packaging process.
“RNFM2 represents a great innovation for the Italian market” states Federico Fumagalli, Chief Commercial Officer at Steriline. “A few years ago we delivered a prototype solution to another Italian customer, but further investigation was already planned. Since then, significant technological improvements have been made to the machine, earning it GMP compliance certification as suitable for drug production. Innovation is the foundation of our business. Our solutions are the result of research and projects development with the goal of offering state-of-the-art solutions”.
The machine exhibited has a footprint of 1.250 m x 1.250 m under the Open Restricted Access Barrier System (ORABS), but can also be equipped with isolators if required by the process. It has a production capacity of up to 2,900 pieces/hour and is designed to manage 0.5 ml PFSs. The machine allows easy format changes, resulting in a very flexible solution that can easily be adapted to businesses’ emerging needs.
“This extremely compact solution allows injectable medicines to be packaged in single doses with a very limited investment in both the short and long term” affirms Filippo Parini, Area Sales Manager at Steriline. "Maintenance and format change costs are very low, and the double inlet/outlet stations reduce machine downtime by optimising production capacity."