Recently I visited a small volume parenteral manufacturing unit and audited that facility as a pre-audit to WHO audits. WHO may visit by end of next month.
I participated in Media fill validation of 10 ml vials. (Their polocy is to fill media every 3 months once). What I observed is after they filled media they put all these 3000 vials for incubation in a Stability chamber.
I argued about humidity in Stability chamber. I found out all their 5 incubators are full with media plates and hence 2 stability chambers were used for this purpose.
I have my own doubts about using Stability chamber-- I think its not a wise move.
I request experts to share some of their opinions on using Stability chamber as an alternative to Inubator.
Thank you all in advance.