Dear All,
I am new here but I have read some treads and they have been really useful so maybe you can help me. I am a Biochemical Engineering student on my final year and I have a case study on discussing the optimal procedures for changeover and validation of fermenters. I understand what validation means but I have no idea what to do for validation of fermenter. I know it has something to do with OQ, PQ, IQ but I do not really understand much. Any help will be much appreciated.
Thank you
Hello Doroulla,
IQ: checking all the system component as per design specificiation. i.e. make and model, range. verification of P&ID for missing component if any.
OQ: checking all the system component performance as per user requirement specification. i.e. drain ability, agitator speed check, load verification
Following tests can be done during performance Qualification of fermenter
- thermal mapping:
To check that every thermocouple inserted in the fermenter reads 121.1 0C with acceptable time lag. - Sterility testing:
Running with a media batch without inoculating with microorganism. Running this media batch as like production batch maintaining all the process parameters as it is. Collecting the samples for media for sterility, pH, Endotoxin.
[quote=prashant.chawla]2) Sterility testing:
Running with a media batch without inoculating with microorganism. Running this media batch as like production batch maintaining all the process parameters as it is. Collecting the samples for media for sterility, pH, Endotoxin.[/quote]
Hi,
If the fermenter is very very very big,i.e.200T,how should we perform the Sterility testing?We should consider the cost.What things we should do for sterilization method for the fermenter?
If your Fermenter is very big carry out media fill. You can use TSB media and fill it and sample it.Regulators are keenly looking now on this and it is applicable for Both Fermentors and aslo reactors which are used in Sterile API powders.