Ramesh Raju Mavuleti*, rrajum@gmail.com, is head of operations, Validation Services India, at Merck Life Sciences Pvt, Ltd.
Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing
Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
Review of SUT Adoption in Biopharma Manufacturing
The evolution of therapeutic modalities drives the adoption of single-use technologies.