I’m looking for a little advice . We have been re-qualifying our washer and tunnel yearly using our 20ml production size vial. we have now introduced a 10 and a 5ml vial size to our production line . These new vial sizes have been fully PQ`d but for re qualifications going forward i read that i only need to re-qualify the worst case vial.
does anyone have any experience in determining the worst case vial size for vial washing or Tunnel depyrogenation ?
Any reference doc / papers who be greatly appreciated
The other approach is yearly rotation of the vial size for requalification.
[quote=griffinneil]Folks,
I’m looking for a little advice . We have been re-qualifying our washer and tunnel yearly using our 20ml production size vial. we have now introduced a 10 and a 5ml vial size to our production line . These new vial sizes have been fully PQ`d but for re qualifications going forward i read that i only need to re-qualify the worst case vial.
does anyone have any experience in determining the worst case vial size for vial washing or Tunnel depyrogenation ?
Any reference doc / papers who be greatly appreciated
Hi,
Regarding the Tunnel requalification, first of all, you need to issue an assessment report to evaluate the worst case vial; the parameters to evaluate are the following:
Fh results (assuming that you did 3 runs for each vial in the PQ);
Exposure time above 230 or 250 ºC;
Vial height, usually the worst case is the highest vial;
Vial neck, usually the worst case is the narrow neck.
Vial mass, usually the worst case is the highest mass vial.
Regarding the washing machine, again, an assessment report must be issued in order to evaluate the following:
Vial neck, usually the worst case is the narrow neck.
Internal area to wash, the bigger the area the worst case.
Yes, it is common to validate worst case configuration. But for tunnel and washing machine is often hard to define worst case configiration.
Why?
For depyrogenation tunnel it is easy if all parameters are the same, then you can check initial qualification and see Fh values and temperatures.
Usually paramaters are not the same (temperature, belt speed) so you must make a evaluation of parameters and datas.
For washing machine is problem that you have no data if you perform only NaCl testing. From my experience small format is worst case but critical parameters are pressure, temperature and time (speed) of washing. After resume all of this parameters you can define worst case.
After completing PQ of each vial size (3 runs each initial/middle/end). It is expected to verify each vial yearly by taking 1 run as vials are coming under critical load.