for sterilization tunnels;which one important for validation of sterilization tunnel temperature distrubition of empty tunnel or temperature distrubition with loaded ?and why?
To qualify a thermic equipment, you have to perform all of these tests. The purpose of the first one or empty test, is to have a temperature mapping, as it is called you are qualifying the operation (OQ), you just are demonstrating that the equipment runs ok and identify the cold points in it.
The second one or with load is the performance qualification (PQ), and you have to demonstrate that your cold points (discovered in OQ) can achieve the reduction of 10^-3 log your microbial load. In cold points you have to put the probes joined with biological indicators (endotoxins) and these allow you to demonstrate that in cold points the endotoxins are inactivated too (it is the philosophy of the worst case, so if in the cold points endotoxins are inactivated in hot points will be inactivated, too).
The recommendations is to perform per triplicate as the initial qualification and annually you have to verify the status of qualification with another run (OQ and PQ).
Generally, lateral sides and the first depirogenated material are the worst case.
I hope that this brief comment can help you.
Thanks Laura very informative!
As you said, the first depyrogenated material is the worst case, do we need to discard the first depyrogenated material. For example, I am running vials, do I have to discard initial depyrogenated vials. If so how many? Can you guide me to any guidelines suggesting the same. Do we need to discard fisrt depyrogenated material even in regular daily activity.
Worst case means, the max mass load configuration (maximum number of vials which can be placed for depyrogenation during routine production runs) and there is no any reqyuirement for discarding the depyrogenated vials.
As Laura mentioned that the first depyrogenated vial will be considered as worst case , In Actual it is not the case as defined.
Worst Case Scenario means that the mass load configuration which have a highest probablity to create a problem in process of depyrogenation. It has maximum number of vials of smallest sizes of change parts of that tunnel.
If an equipment qualifies for the worst case scenario with consistent satisfactory result than it will qualify for all possible conditions .
Mr. Ahsan gave nice and appropiate reply