Leak Testing for Blister Strips

I am having a hard time finding references for the specifications and procedures of leak testing for blister strips and i have read one of the SOP posted on this site. I would like to ask if how many samples do i need for every batch of tablets to conduct leak testing? How can I say that this batch will be rejected or passed? By the way we are using MFY-01 leak tester and we are only observing bubble formation. Thank you. I am hoping for your response. More Power!

The total number of consecutive strips sealed by the full rotation of the sealing roller in case of Aluminum strips and forming plate in case of blister are to be taken for the leak seal test and Pinhole test.

2 Likes