Dear forum members,
Recently we have performed cleaning validation study on Biological manufacturing process.
We have taken a Final WFI rinse sample from fermentor which is meeting the acceptance criteria for TOC i.e NMT 500ppb. Simialry we have taken a Swab for estimation of bioload after CIP, surprisingly swab found the Numerous count.
my query is " is TOC technique is not suffice the measurement of microorganism in rinse sample or can we correlate TOC with any other measuring technique’.
Thanks in advance…
R.Dasarathara Rami Reddy…