Dear daniel_aut:
I want to ask you more info on your "daily performance verification." What tests do you perform for what modules?
I am asking you because I know what must be done, and the time needed for the "performance verification." We need 2-3 days to complete all tests for our "performance verification." Our frequency is six months. Are you in USA? We have been audited year after year!
The title of the post is about LC vials. But then the actual question is about the septa/septum of the vial caps.
I have written about the risk of using the vial caps with non-cut septa on this forum a few times. I called it the "first injection penetration problem."
Perhaps daniel_aut is a newbie? Just start to learn the rope?
From my experience, you shall avoid the caps with non-cut septa. We have done that ~ 10 years ago.
I have seen needles of autosamplers (Shimadzu, Perkin-Elmer, etc) could not penetrate the septa, and the needles pushed the septa down into the vials.
I was in a supervisory position when I had to write two OOS investigations (~10 years ago) related to the vial caps.
The first OOS occurred when a chemist used the caps with non-cut septa on the Shimadzu HPLC. All vials had the first injections with significantly lower areas than the following injections. Prior to this OOS, we allocated the caps with non-cut septa for the Dionex HPLC, and the caps with pre-cut septa for the Shimadzu HPLC. As a CAPA from this OOS, we discard all caps without pre-cut septa, changed our SOPs, re-trained chemists.
The second OOS occurred because the vial caps without pre-cut septa were used. We ordered the right caps; however, the vendor made mistake and shipped some caps without pre-cut septa. Our CAPA was to inspect each shipment of vial caps, and remove/reject the wrong caps.
Thanks for reading. Today is Veteran Day in the USA. Thanks to those who served!
Alfred