Most literature for the PQ of a vial washer states that the following tesating should be perfromed.
Can someone explain why endotoxin is performed instead of microbial testing?
We are trying to get away from endotoxin testing as we do not perform it in house and it is expensive!!!
[quote=Austin]Most literature for the PQ of a vial washer states that the following tesating should be perfromed.
Can someone explain why endotoxin is performed instead of microbial testing?
We are trying to get away from endotoxin testing as we do not perform it in house and it is expensive!!![/quote]
Dear Austin,
BET testing is nessacary in PQ of vial washing b/c if the vials wil have previously contaminated with endotoxin, so Hot WFI can get rid or reduce the endotoxin level beore entering the depyrogenator due to this the efficiency and assurity of depyrogenator can be easily get . as far as cost of endotoxin testing, it is not v expensive if you use gel clot method.
Thanks
We currently test the WFI inlet to our vial washer, do anyone of you experts out there know what the requirement for the rinse water is. I think that I have read somewhere that the final rinse water shall have WFI quality, for injectables, and since you should test the water as it is being used this means that you should test the water coming from the rinse needles. So my question is a variation of Austin´s, is it neccesary to analyse the WFI rinse water from the needles in a vial washer or is it sufficient to analyse the WFI feed to the machine, or can you skip microbiological testing completely and just go with endotoxin test and particulate matter?