My question is about filled SIP (f SIP) of a fementor validation. during f SIP agitator needs to be on or off? if agitator is on thermocouples may wrap around the agitator and we can not even figure out the probe location as they me move from their location as agitator is on. in this case what we need to do. agitator needs to be on or off?
Thanks in advance.
In fermentors both CIP and SIP activities are clubbed together.
Do you use this as a Sterilization procedure or not?
Secondly are you referring a test called Fingure test to note reading on a thermocouple if the required temperature is attained or not?
Clarify these first. Then answeres will follow.
Dear Durga Prasad,
I use this as a sterilization procedure.
and we are not referring any fingure test.
Thermocouples must be arranged literally all parts of a Fermontor including entry and exit ports.
You must find a relation between the pressure and temperature for atleast 10 minutes.
Saturated steam must always been used for this purpose.
Not more than 1 psig is lost after fermentor attains 10 psig after 10 minuts.
No need to agitate the fermentor in SIP.
Do not get angry or agitated after you read commenst bellow. Its a kind advice to you.
It seems you do not get the terminology right at first place.
When you work in Bioprocess area your terminology must be very apt.
It shows that you are not from Bioprocess experience.My suggestion is before you get your methodology right, you either follow your inhouse procedure or approach a consultant.
If you have a pit fall in CIP/SIP procedure of a fermentor and its GMP contols, you end up in DUMPING all the batch before it reaches your downstream process area for clairification.
Get things very right at this stage as all the material of interest for your organization depends up on the Growth rate with out any extrernal and extraneous contaminations at its first place.
Dear Mr. Durga Prasad thank you very much for your reply.