What will happen to a freeze dryer in case of failure of electric power supply during drying?
Have you done risk assessment for the same?
No, I don’t have the procedure for Risk Assessment also.
Do risk assessment for the manufacturing equipment. Refer these documents.
Lyophilization is very critical process.if power fails for long time it will affect the cake formation and there will be Chance of batch fail.continue monitoring of lyophilization is required.Alarm will generate during power failure.Power failure should not be more than 2minute.
IN your SOP you have mentioned RPN criteria is 3-6 how it comes is it RxPxN or R+P+N???
thanks for your question if the electricit powe is swithched off or there is a powe failure it impacts the cycle leading to change in the physical characterstics of the cake including the collapse or disapperance of the cake etc so it is very much advisable to connect the lyophilsier to 24 x7 uninterrupted power supply when the main power is cut off the generator should be immediately connected with automatic change over
Is there any guidelines or allowable time for each powerfailure
There is no guideline for power failure timing, maximum time taken by DG set to start is 2 minute. you can validate the time.