Dear friends,
i m trying to get information about fermentor - performance qualification…can any one guide me… if anyone hav model protocol for the same pls send me to k.jegadeesh@gmail.com
regards
jagadeesh
We do not send protocols by mails.
We will post here in Bioprocess section.
I need to know what fermentor you are using for: is it for bacterial/yeast cells or CHO/cell lines?
we are using bacterial/yeast
regards,
K.jagadeesh
Dear friends,
can any one tell me what are all the studies need to incude in the performance qualification of fermenter.
We have fermenter with the capacity of 1 KL sartorius make and we are using for bacterial / yeast
Regards,
jagadeesh
Dear Mr.Jagadeesh,
I think Sartorius would have given you the PQ protocol for their fermentors.This is a standard pratcice for that company as per their installation program. More over the head office in India is in the same city where you are sitting right now.
Do you have any problem with their protocol?
Honestly speaking PQ protocols are based on URS. We do not have any information on your system specification and interface softwares.We do not have even how many dosing ports and extra pumps you have for loading media and or we do not know if you are doing a FED BATCH or Batch fermentation for your recombinant cells.
With too little information we cannot write a protocol.
I would kindly suggest you to contact Sartorius.
There is a reason specific reason and it is that if you write all the details here you would leak the company information regarding the key fermentation parameters to manufacture Biosimilars or Biobetters at your facility.This will bring unfortunately bad repute to you.
We do not want to share the critical details with you too. We have some Non Disclousure agreements too at our end here.
The best thing is that you mail to Mr.Graham (The moderator). We will make a good PQ and send thru mail if our moderator agrees for this.
Otherwise its too difficult to share information and also specific knowledge.
If Moderator agrees we assure that you will have that PQ protocol for free (with out charging you a penny or a rupee) shall be mailed to you.
This is a sensitive issue so right now we cannot take any call on this particular issue.
Regards
Dear Frnd,
thanks a lot for your valuable suggestion, could u send me Mr.Graham (The moderator) mail id
Thanks & Regards
jagadeesh
Look profile of Mr.Graham. Then you can send a personnal message to him from his page. That is the easiest way.
Regards.
thanks a lot durga prasad
regards,
jagadeesh