This document summarizes the risk analysis carried out as part of the control of particle contamination contamination of single-use assemblies (SUS) manufactured by Pharmasep.
Particulate contamination risks were identified on the basis of a 5M analysis.
This analysis enabled us to identify the appropriate means of controlling the particulate identified.
Click here to find out more : GEN-042.01 Brochure Contrôle Particulaire