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2023 Aseptic Conference

SES201a - Technology Drives Change: New Concepts for Gloveless

‐ Mar 7, 2023 12:30pm

New transport technologies based on electromagnetic levitation are going to change aseptic manufacturing. Introducing new degrees of freedom to gently handle individual doses and environmental monitoring goods. That will carry "Dark-Cold-Dry" manufacturing concepts from vision into reality. Manual interventions including trouble shooting could be replaced by robotic systems, which are easy to teach/manipulate. This perfectly matches requirement for "Appropriate Technologies" in New EU GMP Annex 1 by separating operators from aseptic core environment, replacing manual handling by automation and by speeding up microbiological assays to confirm sterility of manufacturing environment and product. The combination with traditional robotics opens even more flexibility for individualized medicine under 100% control and tracking of product doses. Replacing manual work by automated procedures might even push ATMP manufacturing into ATMP production on highest GMP level.


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