India-based Shilpa Medicare Limited is one of the largest specialty generic pharmaceutical companies in the world. They sought a new pilot line with an extremely small footprint to process vials, pre-filled syringes (PFS), and cartridges for injectable oncology drugs. Another caveat: they wanted to system to function with very limited human intervention.
They worked with Steriline, an Italian provider of aseptic processing machinery and 10-year partner to Shilpa Medicare, to develop an innovative filling, stoppering, and capping system.
Steriline designed a robotic line composed of a semiautomatic Robotic Nest Filling Machine (RNFM1-Lab) and a Vial Capping Machine (VCM50), both able to process the three required formats. Steriline reports, “The two machines were designed to work together: they operate independently with human intervention needed to move the containers from the RNFM1-Lab to the VCM50.”
The RNFM1-Lab is equipped with a foothold station where operators manually peel sterile bags containing tubs; Tyvek is also removed from the ready-to-use containers using a manual tool. Per GMP guidelines, the entire peeling process is performed under laminar flow.
The operator then places the tub containing the nest with empty glassware into the machine’s withdrawing station, where the robotic arm takes the nest and moves the containers under the filling needle and stoppering head.
Steriline reports that the filling process is performed by a peristaltic pump, and it can fill a wide variety of containers. Tubes link the pump to ready-to-use (RTU) bags, opened under laminar flow and filled with the components of the injectable mixture to store. The continuous process does not require changes related to glassware capacity. At the end of the process, the nest with filled and stoppered glassware is discharged by the robotic arm of the exit station.
RNFM1-Lab is also equipped with a continuous air monitoring system for viable and non-viable particles to check environmental parameters as required by GMPs and FDA-compliant practices: particle counts, microbiological count, bacteria monitoring.
Once the RNFM1-Lab has discharged the nest, an operator moves the glassware to the entering station of the VCM50, de-nesting the vials with the help of a tool. A rotating table moves the containers into the capping area. Viable and non-viable particles are continuously monitored, and sensors automatically reject any incorrectly capped glassware. The VCM50 can process 50 pieces/min.
Steriline is well-versed in implementing robotics in its solutions, which have several benefits: containing the machines’ footprint, replacing operators to reduce exposure risk, and reducing overall dimensions. With machine size a critical factor, the system fit into Shilpa Medicare’s planned space: the RNFM1-Lab is approximately 1.20 meters long, while the VCM50’s footprint is about 1.0 x 0.7 m.
Additionally, the smaller design makes it easier to reach every part of the machine through gloves. Robotics also increase the flexibility of the machine, allowing it to process different kinds of containers with minimal format changes and downtime. “Robotics contributes to consistent benefits in terms of cost-effectiveness in the medium-long term. It requires a higher investment at the beginning but, after that, very low additional costs are needed for adaptations and improvements.,” noted Filippo Parini, area sales manager at Steriline.
Shilpa Medicare was also interested in Steriline’s capacity to assist Indian clients and solve issues with prompt interventions in 24 to 48 hours, thanks to technicians onsite. “Steriline’s engineers and technicians are very experienced and understand our requirements precisely,” said Pradeep Shivkumar, AVP formulations development at Shilpa Medicare. “At the beginning of this project, we had a very good technical discussion with the design team and, during the entire development phase, Steriline provided us with very detailed information about the machine’s design. It is not a surprise that this machine was customised exactly as we needed it.”
The robotic line is now installed at Shilpa Medicare. The project was delivered in less than one year despite the restrictions imposed by the pandemic situation—software tools to perform virtual Factory Acceptance Tests (FAT) assisted in the effort. Shilpa Medicare is already looking ahead, having placed an order for a second robotic line with an isolator.