-
stability test
Good day all,
I would like to ask, if the lab scale sample pass the stability test, can we assume there should be no problem with production scale? thank you:) -
6 Replies
-
Of course not, you can only pray. There are countless things that could go wrong. And that’s if you can successfully scale your lab sample.
Given the fact that you can’t replicate the exact conditions in both batches you must make another.
-
thank you for your opinion DAS, that’s mean we dont have any choice but proceed to production scale and do the stability test and see whether it is the stable or not? thank you:)
-
The lab scale stability test usually gives a good indication that the product should be stable when made at a production scale but it is certainly not a guarantee. As @DAS mentioned there are many things that can go wrong when scaling up from lab size samples to production size.
-
Or in another words, EVERY batch needs to go through testing as per specs.
-
Of course, if you do a stability test on a lab sample and it fails, you certainly wouldn’t want to proceed to production with that formula.
-
All the final results (like stability test) should be made for the normal industrial batch you are going to put on the market.
Log in to reply.