i have a question conserning PQ of the vacuum pump. We do have a vacuum pump that is to be used for several applications (eg. for rotary vacuum evaporator and as an waste sunction-pump for synthesizer). For all the applications the performance desired is slightly different. How do i define limits of the PQ tests here? I mean, we do need the pump to be able to reach desired pressure while connected to 100 L waste chamber during certain time, as well as in another application reach different pressure while connected to 5-10 L evaporator apparatus. Do i need to do PQ several times (for each application once)? Thanks!
If the applications are run in parallel, maybe take the worst case (all applications running) and show vacuum performance (degradation less than some %) over an extended period (shift). Otherwise, maybe bookend the PQ with the best and worst cases and run both over an extended period. That would seemingly allow justification for anything in the middle. Document your rationale for whatever you decide (that tends to force a bit more introspection, often resulting in a more conservative approach).
Hello everyone,
We have several vacuum pumps, of same type. Only we use them for different applications(filtration of liquids under vacuum, vacuum for tablet pressure for preparation of sample for IR testing). How I shall define acceptance criteria, if there are not any acceptance criteria in guidelines.