Dear all,
As guidelines, for aseptic fill with sterile filtration, we can prepare the solution at Grade C enviroment; If we prepare the solution at Grade C, can we transfer the mixing tank/storage tank to Grade B enviroment, and filtered before filled?
When transfer the tank to the Grade B area, any procedure need to be done?
Can we install any WFI point in Grade B?
Thank you and regards,
Teo
Dear Mr. Teo ,
As guidelines, for aseptic fill with sterile filtration, we can prepare the solution at Grade C enviroment; If we prepare the solution at Grade C, can we transfer the mixing tank/storage tank to Grade B enviroment, and filtered before filled?
Ans: It is not recommended to transfer tank from Class C to Class B, it is better to filter the solution from Class C to Class B by applying nitrogen pressure in manufacturing tank to Filling tank through silicon tubes.
When transfer the tank to the Grade B area, any procedure need to be done?
Can we install any WFI point in Grade B?
It is not recommended to install WFI in Class B area.
Regards,
Y.Nagesh