With the revision of Annex 1, cleaning is now an integral part of the Contamination Control Strategy (CCS). Consequently, a project to implement an automated cleaning solution can no longer be approached from a purely technical perspective.
Our experience shows that success rests on three pillars:
A rigorous methodology, spanning everything from drafting the User Requirements Specification (URS) to final qualification.
Beyond regulatory requirements, a well-structured project also helps reduce qualification deviations, improve process reproducibility, and boost overall facility performance.
In our article published in issue No. 88 of La Vague, written in partnership with Virbac and Cophaclean, we share key success factors derived from real-world industrial projects, as well as the opportunities that digitalization and artificial intelligence offer for GMP cleaning systems.
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