As automation continues to transform production lines, highly regulated and controlled industries like pharmaceuticals and food stand to benefit the most. In pharmaceutical packaging, the adoption of robot-based automation solutions is accelerating along with the industry’s rapid growth. But aseptic conditions and rigorous cleaning can put equipment to the test. And, driven by strict US FDA regulations and the revised EU GMP Annex 1, equipment used in highly monitored Grade A rooms must constantly evolve. Challenges like these are precisely what Stäubli robots are designed to solve.

Groundbreaking Stericlean evolves into Stericlean+

The original Stäubli Stericlean robot series was launched in 2008, making it the world’s first robot designed to operate in aseptic production areas, particularly inside isolators and RABS. Today this unique range of robots is widely used in pharmaceutical and biotech labs and production facilities worldwide for the multiple tasks of fill-finish machines.

Stäubli customers have realized unprecedented gains in terms of flexibility and safety, keeping throughput at its highest. At the same time, Stäubli engineers have gained nearly 15 years of an installed base in isolators to learn from. Through its close partnerships with leading OEMs and integrators in pharma, Stäubli has expanded its robotics portfolio for pharmaceutical applications. Its new Stericlean+ series is the result: a product that goes one step ahead of hygienic design – and helps future-proof production processes in alignment with regulations.

Launched in 2022, the Stäubli Stericlean+ is designed exclusively for use in isolators. The range includes three six-axis robot series with an improved hygienic design on the covers and new FDA-compliant dynamic sealing on each joint, as well as higher cleanability thanks to a new FDA-compliant coating on the entire surface. All three series are fully tested and validated by Stäubli partner SKAN, a specialist in process isolators.

Completing the package with validation and documentation

Stäubli offers a full range of robots that are validated and include the documentation package required to help machine builders with their qualification while increasing the acceptance of the robot, which is no longer a black box. Given the critical role of decontamination processes in pharma, especially within isolators, Stäubli has run the main tests to validate its robots and evaluated their performance with various cleaning media.

Third-party validation is provided by SKAN, the leading global manufacturer of isolator systems for aseptic drug manufacturing. Stäubli partnered with SKAN’s analytical services, SKANalytix, to refine its aseptic robot design and provide customers with a validation and documentation package, along with full transparency on their robots’ performance.

“Through our SKANalytix service, we provide our customers with analytical support for their questions and concerns around aseptic processing,” says Gregor Hommes, Head of Research and Strategic Business Development at SKAN. “We offer studies around all aspects of isolators, and run tests regarding product, process and operator safety with regard to isolator and cleanroom technology.”

Performance beyond aseptic production

While robot-based automation in isolators is not new, robots are no longer limited to a single task on production lines. The emergence of gloveless isolators and the trend of personalized medicine, leading to small batch production, will broaden the spectrum of tasks assigned to robots. Today, they already manage all steps of the filling process. Tomorrow, with the coming “dark” or “lights-out” factories, robotics and mobile robotics will be at the center of solutions for unplanned tasks such as intervention for troubleshooting. New functionalities will then need to be developed.

Additionally, in factories that lack resources, robotics can expand their repertoire in many other areas; for example auxiliary processes, inspection, and secondary packaging, where many operations are still done manually, with endless loading and unloading of materials causing musculoskeletal disorders in workers. Increasing automation in all of these processes brings benefits of efficiency and error minimization, while continuous production enables manufacturers to meet rising demand.

The flexibility of Stäubli’s standard, Stericlean and Stericlean+ robots is also a key factor: Whether in a small isolator or in a complete production line equipped with multiple robots, within highly controlled areas including freeze dryers impacted by the new GMP Annex 1, non-classified rooms, or intermediate levels where cleanability remains essential, they can manage a variety of different RTU containers, making changeovers to different formats and sizes quick and easy, thanks to the Stäubli Connectors division and its variety of tool changers. This is also becoming important as personalized medicine enters the industrialization phase with production scaling up.

In downstream production, Stäubli robots continue to make significant contributions to processes in logistics areas where no cleaning requirements apply. High payload and mobile robots precisely carry out operations, providing more data and enabling the traceability required for sensitive pharmaceuticals and food supply chains, guaranteeing safe transportation and distribution. “From the first molecule to the shipment, robots play an essential role in the pharma manufacturing chain," says Sebastien Lagarde, Global Pharma & Medical Market Leader at Stäubli Robotics.

Live demo at Interpack 2023: seeing is believing

As a major event in the packaging industry, Interpack showcases innovations along the entire value chain, covering packaging materials, packaging machines and related process technologies. In Hall 15, Stand C37, Stäubli will demo the flagship TX2-60 Stericlean+ robot within a new isolator cell.

The Stericlean+ TX2-60 robot will perform each step in a standard filling application including picking containers, filling them, weighing and capping them with high repeatability, accuracy and output – bringing the degree of human intervention down to zero, significantly reducing the risk of contamination.

The new Stericlean+ range is only the beginning of the complete Stäubli pharma offering, which will bring even more advanced capabilities in the next two years. Interpack 2023 attendees can learn more about the company’s ongoing innovation in process technologies in Hall 15, Stand C37.