Pharmaceutical Technology - May 2022

Pharmaceutical Technology- May 2022

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Page 40 of 63

40 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Aseptic Processing T he Future Robotics Special Interest Group (SIG) of the DACH (Germany, Austria, Switzerland) affiliate of the In- ternational 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 vari- ous 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 fur- ther scenarios for the use of robotics. Subsequent ranking of the sce- narios 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. Regulatory requirements In the production of sterile medicinal products, there are very strict product safety requirements relating to particles and microorganisms. Production employees pose a possible source of contamination. Look- ing at regulatory requirements for the manufacture of sterile medicinal Using Robotics in the Aseptic Manufacturing Facility of the Future Richard Denk, Julien Janda, Markus Stuebchen, and David Wolton Several steps need be taken to achieve lights-out, fully automated operations. Richard Denk is senior consultant for Aseptic Processing and Containment at SKAN AG. Julien Janda is Head of Process and Technology at Takeda. Markus Stueb- chen is Robotics Network Team Lead at Roche. David Wolton is Global Engineering Technology Lead at Takeda. ARIS SUWANMALEE - STOCK.ADOBE.COM

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