The world of pharmaceutical manufacturing is changing. Market trends such as small batches and broader use of gloveless isolators are moving robots to the center of production. At CPHI Frankfurt on 1-3 November, Stäubli Robotics will show how the role of robots can be optimized to deliver even more flexibility and precision.
Stäubli robots hard at work filling and stoppering a nest of ready-to-use vials.
Along with market trends, changes in the regulatory environment are driving new approaches in pharmaceutical manufacturing. Stricter EU GMP Annex 1 and US FDA regulations are heightening the need to minimize the risks of human intervention in sensitive production areas. In costly personalized medicine, the risk must be reduced to zero. Advancements in robotic process automation are removing human intervention from the aseptic process equation.
While robot-based automation in isolators is not new, it is taking on new dimensions as it extends to include auxiliary processes. In the past robots typically performed only a single task on production lines. Now taking center stage, they are able to perform all steps of the filling process, from material handling, filling and closing tasks to troubleshooting, inspections and packaging.
"The future success of market players, both established and new, can only be assured if their production structures meet the demands of a rapidly changing industry,” says Sebastien Lagarde, Global Marketing Leader Pharma & Medical at Stäubli Robotics.
New TX2-60 Stericlean+ robot designed exclusively for use in isolators.
Introducing Stericlean+: Going beyond Stericlean
CPHI Frankfurt is the world’s leading pharma event, and one of the biggest events of 2022 for Stäubli Robotics. The company has chosen this occasion for the commercial launch of its new Stericlean+ range of robots. Designed exclusively for use in isolators, Stericlean+ builds on Stäubli’s already completely aseptic Stericlean range, which has proven its capabilities in life sciences and other sensitive environments since 2009.
Stäubli Robotics worked in close partnership with OEMs and integrators to expand its robotics portfolio for pharmaceutical applications. As a result, Stericlean+ meets all of the market’s requirements today and can help manufacturers future-proof their production for tomorrow.
The Stericlean+ range includes three six-axis robot models featuring a new pharma-approved coating on the complete robot body, new hygienic-design covers, and new pharma-approved joint sealing on each axis. All three models are fully tested and validated by Stäubli partner SKAN, a specialist in process isolators for aseptic filling.
Sebastien Lagarde, Global Marketing Leader Pharma & Medical at Stäubli Robotics.
Precision in action
In Hall 6, Stand 60C70 at CPHI, Stäubli will showcase the flagship Stericlean+ TX2-60 robot for the first time within a new isolator cell. This model features a unique fully hygienic design with an optional hollow wrist and aseptic tool changer. The hollow wrist assures absolute hygienic design. The tool changer, developed in partnership with the Stäubli Connectors division, enhances the flexibility and usage of the robot, enabling quick process changes under sterile conditions.
The Stericlean+ TX2-60 robot will perform each step in a standard filling application, demonstrating its ability to reliably handle a series of auxiliary tasks, including picking containers, filling them, weighing and capping them with high repeatability, accuracy and output – and absolutely no human intervention, eliminating the risk of contamination.
Stäubli will also demonstrate robotic telemanipulation with its Swiss partner Force Dimension, which specializes in force feedback-based haptic devices. Attendees will have the opportunity to use these devices to touch, feel and manipulate vials in a virtual environment.
The right robots for a range of applications
Stäubli’s Stericlean robots are already widely used in pharmaceutical and biotech labs and production facilities worldwide. The new Stericlean+ will bring even more advanced capabilities for a range of clinical and commercial applications, including:
- API and biotherapy production
- Cell and gene therapy (CGT) development
- Biologic and cytotoxic drug processing and compounding
- Auxiliary processes, i.e. loading/unloading, component feeding, inspections
- Filling and closing of vials, syringes, bags and cartridges
- Primary and secondary packaging
Whether in a small isolator with a single robot capable of handling several independent or linked operations, or in a complete production line equipped with multiple robots, the new Stericlean+ range allows processing of different RTU containers, easily accommodating changes in production for optimal flexibility in aseptic pharmaceutical manufacturing.