Please suggest,
What should we have to do if terminal sterilization load fail during sterilization of vials during commercial production batch?
E.g. If sterilization hold time is 20 min. and cycle found with 16 min. then what to do?
Hi,
perform sterility testing and after test results sell the product.
[quote=mit patel]Please suggest,
What should we have to do if terminal sterilization load fail during sterilization of vials during commercial production batch?
E.g. If sterilization hold time is 20 min. and cycle found with 16 min. then what to do?[/quote]
First, you should make RA to see what is your input and what did you get.
See bioburden before sterilization, in a manner to know how your solution was challenged.
Second, see the cycle, compare with validated state (temp, Fo values, )
Collect all informations - did you spike stoppers , which BI and similar.
After all write rationale i explain impact on product and calculate PNSU.
IF PNSU still 10 at -6 release batch.