Media fill- product sterilization- urgent query

Validation
1

Dear All,

Is it acceptable if my media sterilization !!

condition is 121C for 40min and actual observed as 121C for 29 min then observed reading as 120C for next 4 min and again reach to 121C for 7 mins…
Can we proceed for filling or batch to be discarded?

Thanks.

2

As per as regulated market is concern it is not acceptable

1 Like
3

Thanks