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World’s first unmanned, fully aseptic multi-functional commercial filling line for the bio-/pharmaceutical industry

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Enhanced robotic arms revolutionise filling and closing of pharmaceutical containers

Robots play an integral role in the pharmaceutical industry as it continues to push technological innovation to meet product demand. A new system transforms robotic capabilities for a critical area of operations: the pharmaceutical filling line.

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Two major areas where robots can help the industry is in assuring sterility and reducing contamination risk. Traditional filling lines based on mechanical solutions fall short in these respects, potentially exposing machine operators and future patients. The Aseptic Smart project sought to address these challenges by integrating robots into machines and developing machine vision and control systems. Did it achieve its goal? “The answer to this question is enthusiastically affirmative,” states project coordinator Cinzia Butini. Specifically, the project advanced particular aspects of anthropomorphic arms, developed by Denso Robotics, that are used for filling and closing containers. It integrated a system of cameras into the arms that guarantees complete control of the process. End effectors developed within the project are suitable for handling a full range of pharmaceutical containers, from vials and ampoules to syringes and cartridges.

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“The robotic arms interact with robotic groups developed by Pharma Integration, giving rise to an aseptic filling line without the need for manual intervention using gloves and without the need for sensors’ manual adjustment,” Butini explains. A PC-based vision system application makes the latter aspect possible. The cameras on the robotic arms conduct all checks needed to ensure compliant execution. A complex control system enables movement along the line through a single human-machine interface. This is comprised of modular hardware and software packages and based on fieldbus communication, input/output handling and logic functions. Aseptic Smart developed a supervisory control and data acquisition system to allow the smooth transfer of data from the hardware to the software package. Regarding validation of the complete system, Butini remarks that this has been “one of the most important project phases.” A class C facility was utilised to test the functionality of the different system components integrated into a complete filling line. Extended tests have assessed system reliability and performance with a full range of different containers and formats. Notably, the facility fulfilled the same requirements of the final destination environment of a pharmaceutical production department. Two different vial and syringe formats have been run three times in batches of 15 000 pieces each.

Innovation securing today and the future

Aseptic Smart further lived up to its status as an Innovation Action project. “The dark period of the global pandemic had an unexpected fruit, that of the development beyond all expectations of a disruptive simulation tool,” Butini says. A constellation of emulators makes up the simulator and together they recreate the same interface as the real machine in a virtual environment. They also react the exact same way the physical system reacts. “Thanks to the simulator, process code can be written and tested during the phase of physical production of mechanical components and during the integration phase,” Butini concludes. It can be used to develop new solutions and many technical aspects can be thoroughly verified during the mechanical design phase. Used with a virtual reality headset, the system is also an effective training tool for personnel.

Keywords

Aseptic Smart, robotic, pharmaceutical, robotic arm, filling line, simulator

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