Incubation of Media filled Vials

GOOD VALIDATION PRACTICE (cGVP)
#1

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.
Regards

#2

Dear Durga Prasad,

Ofcourse this is not good practice, as rule says ‘that there should be place of everything and everything should be in place’, but as far as argument point of view, we can not chellange this activiy (if predefined temperature for mediafill vials is maintained in stability chamber).
Humidity will not have impact on glass containers.
The firm shall follow same procedure for mediafill container as stability samples, i.e. log of containers in stability chamber, reconcilliation etc.
There shall be procedure of chamber cleaning additionally to it, after removal of media fill containers.

#3

Thanks for your imputs.

#4

In addition, also consider the minimum number of media fill vials, it should be 4750 units per media fill run. Because if 3000 units are filled and one contaminated unit resulted, the upper 95% confidence limit for the contamination rate would not more than 4.73/3000 X 100% = 0.15%, this would not be acceptable. so, I recomend that single run should have more than 4750 units, for logical justification of set limits i.e (alert and action)