Does anyone check blister perforations during validation of packaging process? If so, how do you do it?
Hello
No, however, if you want to do the PAT process, you should do that. And there are cpp like a normal and worst speed,
a pinhole test and a temperature for 3 batchs
however, PQ should be completed even if pv is not necessary.
thank you
Yes. Depending on your customer’s “need” or internal SOP it can be check many ways.
Typically what I have seen is a visual inspection. Complete perf, incomplete perf missing perf etc. You can hold the blister card up to the light and look through the perf to see if it cut through completely.
There is always a physical (destructive) test where you just rip the card down the perf and see how it reacts.