A prosperous strategy for the long-term vision of robotics, fostering a partnership for more than 10 years

Robot nest filling machine (RNFM1-Lab) and vial capping machine (VCM50)

Robot nest filling machine (RNFM1-Lab) and vial capping machine (VCM50)

Steriline and Shilpa Medicare are one of the world's largest specialty generic drug companies, headquartered in India, and recently developed a cutting-edge filling, stoppering and capping solution for injecting tumor products. The two companies have been cooperating for more than 10 years and signed their first cooperation when they both had the emerging reality of expansion strategies, and they have been growing together ever since.

Shilpa Medicare's request is to establish a new pilot production line with a very small footprint for processing vials, prefilled syringes (PFS) and cartridges for injecting tumor drugs. These production lines can work with very limited human intervention.

To meet customer requirements, Steriline designed a robotic production line consisting of a semi-automatic robotic nest filling machine (RNFM1-Lab) and a capping machine (VCM50), both of which can handle the three required formats. The two machines are designed to work together: they operate independently and require manual intervention to move the container from RNFM1-Lab to VCM50.

RNFM1-Lab is equipped with a foothold where the operator can manually peel off the sterile bag containing the bathtub. Tyvek can also be removed from the ready-to-use container using hand tools. The entire peeling process is carried out under laminar flow, which complies with the requirements of the International Pharmaceutical Manufacturing Guidelines (GMP). Once the action is over, the operator puts the nest box with empty glassware into the machine's take-out station, where the robotic arm picks up the nest box and moves the container under the filling needle and stopper.

Half-stopped vial, ready to be lyophilized

The filling process is performed by a peristaltic pump, which can fill an unlimited range of containers with different capacities. A tube connects the pump to a ready-to-use (RTU) bag, opens and fills the components of the injectable mixture under laminar flow for storage. The process is continuous and simplified, and does not require changes related to the volume of the glassware. At the end of the process, the bird's nest with filled and plugged glassware is discharged by the robotic arm of the exit station. RNFM1-Lab is also equipped with a continuous air monitoring system to detect live particles and non-live particles to check environmental parameters: particle count, microbial count, and bacteria monitoring in accordance with the requirements of GMP and FDA compliance practices.

Once RNFM1-Lab exits the nest, the operator moves the glassware to the input station of the VCM50 and removes the nest of the vial with the help of tools. Here, the rotating table moves the container to the capping area. Provide continuous monitoring of viable and non-viable particles, and the sensor will automatically reject all glassware that is not properly capped. VCM50 can process 50 pieces/minute.

Steriline is a pioneer in the application of robotics to its solution, which has a number of valuable advantages: According to the requirements of international standards, and in this case, according to the specific requirements of the customer, it controls the area of ​​the machine and the replacement operation Staff and reduce the overall size. The solution does have a truly compact design, which is very suitable for the area that Shilpa planned for it: RNFM1-Lab is about 1.20 meters long, while VCM50 has an area of ​​about 1.0mx 0.7m.

Filling process performed by a peristaltic pump

In addition, the smaller design makes it easier to access every part of the machine while wearing gloves. The robot also increases the flexibility of the machine, enabling it to handle different types of containers with minimal format changes and downtime.

"In the mid-to-long term, robotics can help bring sustained benefits in terms of cost-effectiveness. It requires higher investment at the beginning, but afterwards, the additional cost of adaptation and improvement is very low. Steriline can even be tested Offering robotic opportunities online, Shilpa Medicare understands all these advantages that robotics provides,” said Filippo Parini, Steriline Regional Sales Manager.

In addition, another strategic skill that Shilpa Medicare considers in the long-term vision is that Steriline can assist Indian customers and solve problems in only 24-48 hours, thanks to the expert agents and technicians on site.

“Steriline’s engineers and technicians are very experienced and understand our requirements accurately,” said Pradeep Shivkumar, Vice President of Formulation Development at Shilpa Medicare. "At the beginning of this project, we had a very good technical discussion with the design team. Throughout the development phase, Steriline provided us with very detailed information about the machine design. This machine was completely customized according to our needs. Not surprisingly."

Shilpa Medicare successfully received and installed a robot production line in its factory, and now expects two complete robot production lines, including isolators, and placed an order with this Italian supplier a few months ago. “Steriline and Shilpa Medicare have grown together and are facing a similar expansion path. Our cooperation is based on mutual trust and is a turning point for the two companies to thrive,” Steriline Chief Commercial Officer Federico Fumagalli emphasized.

Despite the constraints of the pandemic, and because currently available software tools can perform virtual factory acceptance testing (FAT), etc., the project was delivered in less than a year.

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