David Wolton is Global Engineering Technology Lead at Takeda.

David Wolton

The Future Robotics Special Interest Group (SIG) of the DACH (Germany, Austria, Switzerland) affiliate of the International Society for Pharmaceutical Engineering (ISPE) was founded in 2019 and is headed by Richard Denk of SKAN AG and Charly Coulon of Invite GmbH. The group’s aim is to formulate requirements in the pharmaceutical industry and, working in smaller groups, to develop possible solutions for including robotics in a user requirements specification (URS). The group will examine all processes and related issues that are required by robotics or that enable or simplify its use. To this end, an evaluation was conducted with various pharmaceutical companies to determine where robotics could be used most effectively in pharmaceutical manufacturing. A workshop was also held in November 2021, in which small groups discussed further scenarios for the use of robotics. Subsequent ranking of the scenarios then led to the various workstreams. The individual scenarios showed a trend toward the use of robotics in aseptic manufacturing. As a result, the SIG sub-group “Facility of the Future of Robotics for Aseptic Manufacturing” was established. The group brings together all ongoing workstreams related to this topic, with the ultimate goal of achieving fully automated aseptic manufacturing.

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1. EC, Draft Revision to “Annex 1, Manufacture of Sterile Medicinal Products,” (Brussels, 2020).

2. BioPhorum, “Robotics Biomanufacturing Roadmap, Draft Version 1,” presentation at the Pharmaceutical Mobile Robotics Conference (London, UK, April 21-22, 2022).

Richard Denk is senior consultant for Aseptic Processing and Containment at SKAN AG. Julien Janda is Head of Process and Technology at Takeda. Markus Stuebchen is Robotics Network Team Lead at Roche. David Wolton is Global Engineering Technology Lead at Takeda.

When referring to this article, please cite it as R. Denk, J. Janda, M. Stuebchen, D. Wolton, “Using Robotics in the Aseptic Manufacturing Facility of the Future,” 

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Several steps need be taken to achieve lights-out, fully automated operations.