Agilent 1100 PV
Posted: Wed Dec 17, 2014 9:44 pm
Hi everyone.
Hope I don't start an argument, as I'm think there may be two camps on the issue, but:
When performing the carry over tests for PV / OQ that Agilent specify Caffeine and a blank. Would you have a needle wash on in the method?
My initial thought is no as the injector purges before injection and surely you're looking for the amount of carryover from the previous vial. The NW which isn't used in all our methods would, to me, risk giving a false pass as your cleaning the needle. But the validation SOP is less than clear, no needle wash specified but use isn't ruled out.
Thoughts appreciated (or even better someone looking at the ALS settings in the method, we don't for whatever reason have there manufacturer methods on the system). Or a link to pass to QA
Thanks
J
Hope I don't start an argument, as I'm think there may be two camps on the issue, but:
When performing the carry over tests for PV / OQ that Agilent specify Caffeine and a blank. Would you have a needle wash on in the method?
My initial thought is no as the injector purges before injection and surely you're looking for the amount of carryover from the previous vial. The NW which isn't used in all our methods would, to me, risk giving a false pass as your cleaning the needle. But the validation SOP is less than clear, no needle wash specified but use isn't ruled out.
Thoughts appreciated (or even better someone looking at the ALS settings in the method, we don't for whatever reason have there manufacturer methods on the system). Or a link to pass to QA
Thanks
J