We have a biorreactor, used for 3 different production process. So, we have different setup of this machine in different process (different pO2, agitator and temperature control). Do I have to document the performance qualification of each setup?
Can anybody help me? Thanks in advance
[TD=“align: left”]I would suggest that the risk assessment should identify the requirements for the validation strategy. If the OQ has tested the equipment across the range then a basic PQ to demonstrate that the equipment is suitable would be supplemented by on-going PV with appropriate in process controls and data acquisition and review. Essentially it depends on the level of confidence you have in the equipment and what design space you are working in with your process.
I would expect each setup to be included in the review but I would not necessarily require all setups to have been run to accept the equipment into general use. I would be very interested to see what approach others would take here.
[TD=“align: left”]By Chris Morgan[/td]
PQ covers the actual performance of the equipment with actual product or the Placebo. The bioreactors are designed to hold the Microbial or other cells for the required time maintaining the sterility during the interventions. Hence a media hold study for the reactor can demonstrate that the reactor is capable of holding the batch in sterile condition along with the samples withdrawn as planned during the batch.
The parameters inside bioreactor remain same as during the batch. [/color]
This study not only will prove the holding time but also give you assurance that the sterility will be maintained when you start with actual batch.
Sr. Engineer-Validations & Compliance at MNC
Thanks Graham to take here the Linkedin answers! It was very useful! And thank you all for taking time to respond.