Holding time tank media fill

Production
1

Hi all!
Is there a specific time require for the holding time of the medium in the tank of media fill.

Is it ok to connect immediately after the filtration the tank to the machine?

In which guide can I find some rules. PDA? Annex?

Thank you in advance for the answer!!

2

Dear,
Yes the maximum hold time period of media should be established, as bioburden limit as NMT 10cfu/ml, before filtration…

Also the filtered bulk hold time should be also established…as sterile
The filling should be started just after manufacturing and filtration. The activities to be simulated as Media fill run/ Regular batch process…

Guideline
PDA 22
PICS

Thanks

3

Thank you very much @AsifHussain !!!

Wish you a nice day!

4

any reference for bioburden limit 10 cfu/ml before filtration???