Good morning
I have re-qualificate an existent Fermenter in manufacturing department. This is a big Fermenter (geometric volume = 100000 litres).
I have to execute IQ OQ and PQ protocol.
As I said this fermenter is already installed, so is it necessary execute IQ and what are the parameters I must consider for IQ?
Moreover I don’t have any URS, so is it necessary to issue new URS as starting of life-cycle qualification?
At he same time can you help me to consider parameters to fill the OQ protocol?
As regarding the PQ is it correct to execute three batches of standard batch to qualification of this Fermenter?
I would like to know your opinion by considering big volume of this Fermenter. I have also doubts about Performance Qualification because I don’t know what is the correct approach to follow. Can I consider the Fermenter as single equipment for qualification or do I have consider it as part of an existent line in which there are also some others collected equipments such as Germinators?
I hope to have explained well my doubts.
PS
On reading in askaboutvalidation forum I read that it is possible to carry out PQ using TSB media. What is it?
Thank you in advance
Do you have manuals for that Fermentor?
If not get manuals from the manufacturer giving him the model number.
First thing we must know where is the orginal P&ID of the fermenotor.Did any connections were changed from point of installation to this day?
Get those details. We can write a qualification protocol.
We can use our Kneat Validation solution to create such Validation protocols and Risk assessments associated with such quality documents
Hi Durga
I don’t have manual for the Fermentor, as I said it is an old equipment of manufacturing which was not used. It has been cleaned but now it has intentioned to qualificate it.
The P&ID is the same, but the change will be the linking the Fermentor to others Tanks (Germinator). These are the characteristics (by technical service): 130000 volume. It has an external cooling coil with water (3 bar at maximum). It has homologated on going pressure.
It has a stirrer and sparger. All the instruments to check in process-control is controlled by DCS system, but the opening/closing valves has executed by operators.
These all details I found now.
If you need other details you can write it please.
Do you have a CIP/SIP system attached?
Has any pipes and connections seen changed or new things attached?
Are pumps intact?
Do you have a cleaning protocolo before start up?
Just look the manufacturers name and browse in web and contact them thru E-mail. Probably they can send you another operational manual at a price.
This looks massive and expensive Dinosaur.
Try to get the lay out drawings.
I can help you with these details.
Do you have a CIP/SIP system attached?
There is not CIP but a cleaning SOP in which the cleaning is executed washing the fermentor with a water solution + NaOH (48%)
Has any pipes and connections seen changed or new things attached?
No, but as I said the Fermenter shall be linked to Germinator tank
Are pumps intact?
Yes, they are …they are FINDER model, type HC-80A -160
About Stirrer I don’t have model, it has an apparatus wit three blades, six in total
Do you have a cleaning protocolo before start up?
There is a SOP I described before
Just look the manufacturers name and browse in web and contact them thru E-mail. Probably they can send you another operational manual at a price.
OK I will try to contact him
This looks massive and expensive Dinosaur.
Try to get the lay out drawings.
Yes, I can have the lay-out
I can help you with these details.
Ok let me know what you need and how you think to do please
I will be very busy next 6 days. I shall give you a cheklist by monday evening. You can fill it up first and let me know what are missing and then we can proceed ahead.
Regards
Thank you …thank you very much for your availability I will wait for the cheklist next week.
anyway I would like to know if you are agree about the PQ please. Is it correct to execute three batches of standard batch to qualification of this Fermentor?
yes 3 standard batches with all controls in place.
But before that let us first look into what is required to qualify Fermentor (Biorecator).
Then we shall look into Standard batch.
Then another check list will be given to you before start of that batch.
We still have time to reach that point.
Regards