Continued Process Verification Methods In Cleaning Validation

By Sara Ferreti, Ph.D, R&D Fedegari Autoclavi SpA

An increasing interest in continued process verification has led to the spread of on-line assay methods in cleaning processes. This paper deals with two different on-line applications: conductivity sampling and the Total Organic Carbon analysis for washing machines.

The U.S. FDA process validation guidance document released in 2011 increased the emphasis on continued process verification: “ongoing assurance is gained during routine production that the process remains in a state of control”.