Continued process verification methods in cleaning validation
نویسنده
چکیده
The U.S. FDA [1] 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”. Until recently, in a washing system, conductivity analysis was the only on-line method used to monitor the quality of the final rinse water. Now, developments in the Total Organic Carbon (TOC) technology allow its integration into washing systems. A general description of these two assay methods is reported in the next section. In closing, the on-line application of conductivity and TOC on Fedegari washing machine will be briefly described.
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