dear sir,
i am working in a biopharma. pl guide me, how to validate the O2,CO2,N2 and air system for fermentation system.
thanking you
rajnikanth,
Let’s see where to begin. I will start with the assumption that you actually need to validate these systems. So with that, you would need to do an installation qualification - including P&ID verification, calibration, procedural controls, cleaning. Operational Qualification - system use at load, pressures volume, etc. Next you may do a PQ or this may be performed in the OQ, USP testing for the gases. Also you will need to look at the requirements for the fermenter and asssure that your gas system meets them. Oh, if there are any alarms for this system test them in you OQ.
Interesting, I have never done this type of validation before, does calibration testing cover testing the concentration levels of the gases?
The calibration testing in the OQ is the same as any other IQ, verify that gauges are calibrated and in a PM program. (I am guessing pressure, temperature and possibly concentration) Most of the time in the states, we get a CofA for the gas, but QA always requires some sort of identity test.
I am wondering why to even validate this. I was thinking this could be a commission only type utility. There are probably valves at the fermenter to control pressure and input. You could just verify in the fermenter that the proper utilities are present. The gases are not being generated on site.
Yes agreed Mr Myrete! It seems that the gaseous supply are required to feed and stream the fermentation process in gaseous phase. The flow rate and pressure gauges of gases need to be calibrated. The flow rate can be in Mol/min or Litr/minute. So the concentration of required gases should be assured.
Dear All,
How to qualify the commpressed air distribution system.
[quote=sandesh.deshpande]Dear All,
How to qualify the commpressed air distribution system.[/quote]
Dear Sandesh deshpande,
Verify first the PID of the system if it suits your facility, check the operating procedure and maintenance, qualify the design. It would be safe if you would make a URS as basis whether or not your system meets the requirement of your production facility. If necessary, ask for material certificates during design qualification. When conducting tests such as leak test etc., tabulate the results vs. the pressure used. e.g. result @ 120 psi o result @150 psi. Perform IQ, OQ, and PQ.
Not fully ellaborated but hope this helps!
ruthy shelly
+63916-6031021
[quote=sandesh.deshpande]Dear All,
How to qualify the commpressed air distribution system.[/quote]
Dear Sandesh,
Kindly go through below link
http://www.askaboutvalidation.com/forum/showthread.php?t=50
Thanks