Alex Jezequel talks about designing roboFIL™
In the ever-evolving pharmaceutical manufacturing landscape, 3P innovation is making waves with its cutting-edge roboFIL™ system. This innovative aseptic filling solution represents a significant leap forward in addressing the industry’s growing demands for flexibility, sterility assurance and operational efficiency. Alex Jezequel, Projects Director at 3P innovation, discusses how roboFIL™ is transforming pharmaceutical fill-finish operations and the thought process behind its design.
What is roboFIL™ and how does it address the evolving needs of the pharmaceutical industry?
RoboFIL™ is a fully automated robotic system designed for aseptic liquid and/or powder filling of ready-to-use (RTU) containers. As the pharmaceutical landscape continues to evolve, 3P innovation recognised the need for a solution that could meet the demands of smaller batch production and an increasing diversity of product formats and batch sizes.
“Our goal was to enhance sterility assurance while also ensuring that the system could handle varying product formats and batch sizes,” explains Alex. “With the shift towards higher value medicines with smaller production batches, flexibility is critical to manufacturers. The system accommodates vials, cartridges, syringes, traditional closures and press-fit caps, all in different sizes and it uniquely supports both powder and/or liquid filling. As far as we know, this is the most flexible fill-finish system on the market for RTU containers.”
What inspired the design of roboFIL™?
When asked about the motivation behind the development of roboFIL™, Alex emphasised that it wasn’t about solving a single challenge but rather, addressing multiple operational hurdles within the industry. The team sought to deliver a solution that would overcome the limitations of existing systems.
“We provide some of the benefits of gloveless automation while maintaining the operational flexibility needed to intervene when necessary,” Alex explains. “Gloveless systems are vulnerable because if an unexpected issue arises, you can’t simply put your hands in to fix it. With roboFIL™, we’ve minimised gloved interventions, for example by adding automatic settle plate and active air sampling changeover, providing some of the benefits of gloveless automation without the added risks.”
How did you enhance contamination control in roboFIL™?
Contamination control takes centre stage - roboFIL™ was meticulously designed to minimise risks from every angle. According to Alex, the team designed roboFIL™ from the ground up in line with the latest Annex 1 regulations.
“We took detailed advice from multiple regulators, including some original contributors to Annex 1 ” Alex shares. “This approach led us to take very careful steps in the equipment design to enable a compliant setup procedure. For example, to ensure that pre-sterilised change parts can be installed aseptically, without compromising first air during the setup process.”
The result is a machine which supports a robust Contamination Control Strategy (CCS) by significantly reducing contamination risk at every step.
Where does the term ‘Plug and Go’ come from?
“One of the standout features of roboFIL™ is its compact height and footprint, which not only simplifies installation but also reduces energy usage. This design ensures seamless integration into existing cleanrooms with minimal disruption – i.e. ‘plug and go’. Our on-board air recirculation system further reduces installation complexity by minimising the need for external services, streamlining the process.”
Can you tell us more about the vision-based picker system?
Another innovative feature of roboFIL™ is its vision-guided picker system, which was developed in collaboration with Asyril, an industry leader in flexible feeding systems. Unlike traditional bowl feeders, which require specialised designs for each product, roboFIL™’s vision picker can quickly adapt to handle a variety of components, such as press-fit caps, crimp caps, stoppers, and plungers. The system uses a camera to locate components on a tray and signals the robot to pick them.
“The vision picker enables multiple component formats with just a simple recipe change,” Alex explains. “This approach reduces downtime and increases flexibility, providing CDMOs with the agility they need to meet changing demands. Also, gone are the requirements to wrap bowl feeders and transfer them through lower grade environments, this vision picker allows safe hygienic transfers via beta containers in Grade A environments”
How do automation, machine learning, and AI play a role in roboFIL™?
Incorporating cutting-edge automation, inspection and measurement technology, roboFIL™ provides precision across a range of processes. Alex highlights the advanced technology behind the system’s operations, including the use of Stäubli Stericlean+ robots, Zimmer electric grippers with inbuilt position feedback, and multiple 100% inspection and feedback systems.
“With powder applications, we use closed-loop algorithms to dynamically adjust powder dosing parameters in real-time,” Alex says. “This ensures that environmental factors such as humidity or temperature don’t impact the consistency or quality of the product. With this level of automation and feedback, roboFIL™ can maintain a consistent output while minimising human intervention. We also include 100% stopper and vial inspection as standard”
What are the upcoming developments for roboFIL™?
The future looks bright for roboFIL™, with exciting new applications already in the pipeline. “Our first real-world application of roboFIL™ is with Dalton Pharma Services in Canada, where they required a flexible system capable of handling challenging powders,” Alex reveals. “Our patented Fill2Weight™ gravimetric powder filling technology has proven to be particularly effective for their needs.”
As the pharmaceutical industry continues to evolve, roboFIL™ is poised to play a central role in the future of aseptic filling operations. Its ability to adapt to a wide range of product formats, while maintaining high standards of automation and sterility assurance, positions it as a future-proof solution for manufacturers looking to stay ahead of the curve.