Hi,
Does anybody know about any stability test which link to Limulus Amebocyte Lysate (LAL) Test?
I know it is all about sterility testing only. Can anybody help?
Hi Ethan.
The LAL testing concerns to the endotoxin limits in a solution or for a product after the extraction from it into a solution.
We have the same LAL tests done on our pure water which corelates well with the pooled endotoxin test of the medical devices that are subjected with this water during the calibration, leak test and final cleaning process. This is a sort of stability test for our pure water system performance.
Sterility concerns to distruction of bacteria while LAL test concerns to level of dead bacteria shell of the gram negitive which in excess to some limit is disease causing