Regarding validation of a chromatography column
Posted: Thu Feb 07, 2008 10:56 pm
Hi there,
An existing process runs 2 cycles through a chromatography column and has been validated.
The process is changed and now 4 cycles run through the fermenter.
What would need to be revalidated and why?
so far i have column capacity and the CIP/SIP procedures as well as scheduling of the overall process.
any more ideas???
An existing process runs 2 cycles through a chromatography column and has been validated.
The process is changed and now 4 cycles run through the fermenter.
What would need to be revalidated and why?
so far i have column capacity and the CIP/SIP procedures as well as scheduling of the overall process.
any more ideas???