A Glatt fluid bed drier has been installed and I am in the process of drawing up the OQ protocol for the machine. IQ has still to be performed. IQ looked at documents, piping, drawings, alarm, safety devices logging onto calibration and PPM systems.
I wonder if anyone has validated the same equipment and if anyone can give me guidelines for OQ tests to be performed. I have listed alarms, inlocks, safety device operation, calibration of critical devices (Thermocouples etc) documentation availability and training. Regarding the functionality of the various controls and sequences of the process would I have to list each sequence and download each screen to verify the operation of the steps.
First of all I would examine the FDS to find out what exactly are you requirements for testing. I find it’s a good idea to write the IQ and OQ together so that no testing is missed at the FDS level, which is the driver for the IQ/OQ testing.
Some OQ testing that sp,ring to mind include:
[LIST=1]
Verficiation of insturmentation calibration
SOP's
Discrete I/O - Inputs
Discrete I/O - Outputs
Analog I/O - Inputs
Analog I/O - Outputs
Operational Functional Testing
Trips, Interlocks and Alarms
System Error Messages
Loss of Power Test
System Start Up
Access Permission
Menu Access
Shut-Down
Screen Testing
Security Testing
Part 11 TestingI would test the functionality as per intended use, in my view why waste timing testing sequences that may never happen.
Try and pinpoint what exactly are the critical sequences in the functionality and provide screen shots if neccessary.
Organise a meeting with the people who know the system best and try and come to some agreement as to what is the best testing approach.
Doesn’t Glatt sell a validation package? I would buy that. I’m pretty sure they do a comprehensive enough package for your use. Was there start up and commisioning or FAT, or SAT? Typically those are renditions of IQ/OQ. If not do what Graham wrote.
Don’t forget the M&E - C&I stuff either. These systems are effectively huge hair dryers
So you would also need to confirm the volumetric throughput (upper and lower) and temperatures (upper and lower) of air from the HVAC system in the plant. Not forgetting all of the inlet and extract HEPAs and explosion protection devices, product contact parts, screen mesh sizes, seals and vacuum transfer hoses (if applicable) etc. Oh…and then there’s the CIP nozzles and temperature checks also.
Thanks for all your help. Problem has been that the equipment was purchased second hand, and the manuals received were basic that were handed over to us.
