A combination to guarantee safer processes and minimise sterility breaks
Steriline, the European manufacturer of standard and robotic lines for the aseptic processing of injectable drugs supplying pharmaceutical companies worldwide, welcomed visitors to its booth #E69, Hall 3.1 at Achema 2022, 22 - 26 August.
After four years, the international trade show for the process industries that attracts visitors from all over the world arrived back in-person. Steriline presented a Robotic Vial Filling and Capping Machine under isolator (RVFCM50) and a Robotic Nest Filling Machine under double-wall isolator (RNFM5).
The RVFCM50 can process up to 2,400 pcs/h. Once vials are washed and depyrogenated, the first of three robotic arms grasps two vials at a time and places them under the filling heads, which are linked to two peristaltic pumps that potentially allow infinite capacity filling. This step happens directly on two weighing cells, so that the filling volume can be checked in real-time during filling operations and the recipe parameters can be met.
Once they have been properly filled, the vials are moved to the second robotic arm for the stoppering process and then to the third robotic arm for capping. Whenever the check sensors detect any non-conformity during filling, stoppering or capping, the process can be repeated to guarantee the conformity needed according to the company’s “robotics zero-loss philosophy”. “The main processes of primary packaging are three: filling, stoppering and capping,” explained Filippo Parini, Area Sales Manager at Steriline. “In traditional solutions, they may fail, leading to non-compliant products being rejected. Steriline’s ‘Zero-loss philosophy’ aims in this case to avoid waste. Sensors combined with robotics can detect any problem and ensure the process is repeated until the requested standards are achieved.”
The machine was designed to manage highly potent drugs that are potentially dangerous for people and, for this reason, it is equipped with an isolator that ensures the sterility of the processed vials and protects the operator at the same time. This new robotic line will allow the customer, a Contract Development and Manufacturing Organization (CDMO), to:
After the successful delivery in 2021 of a pilot line for the primary packaging of small batches, the order from the customer for this line comes as a testament of its satisfaction with Steriline’s solutions and services.
The RNFM5 under double-wall isolator can process every container that comes in nested form, including syringes, vials and cartridges. In the filling area, a vertical manipulator, equipped with suction cups, removes the nest from the tub, allowing the first robotic arm to pick up the nest and place it under the filling needles and stoppering heads. A second robotic arm picks up containers and performs the statistical weight checking process, with the help of five high-precision weighing cells located on the machine baseplate. The glass containers are then moved under five dosing heads and simultaneously stoppered. Seals are used on syringes and cartridges, while vials are stoppered with the all-in-one closure system developed by ARaymondLife (which integrates plastic push-fit caps). In addition to the weight-checking sensors, which ensure the right fill quantity, the machine is also equipped with Steriline’s smart bung system, which can detect the conformity of the stoppering process. “Every step of the process must strictly fit the customer’s and industry’s requirements to ensure the highest product quality,” said Federico Fumagalli, Chief Commercial Officer at Steriline. “Steriline’s projects are always developed to provide the highest quality standards and, with this in mind, we are committed to intense R&D activity to develop innovative tools capable of improving the performance of our solutions. In this case, Steriline’s smart bung system relies on pressure sensors to monitor the stoppering process. If anomalies are detected, the process can be repeated to ensure containers are hermetically sealed as requested.”
The RNFM5 answers to the client’s need to introduce a new production line to start the commercialisation of a new biotech drug. Its output is up to 10,000 pieces/h with a double-wall isolator solution that guarantees sterility throughout the entire process and maximum safety for operators. This solution perfectly satisfies all the requirements for the production of extremely sensitive drugs, such as biosimilars and monoclonal antibodies, in addition to biotech drugs.