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1. The in-line steam sterilization specifications of sterile grade filter cartridge
The bacterial removal terminal filters need to be in-line steam steriled for the safety production in pharmaceutical industries, because of their different high polymer materials construction, the steam sterilization have to followed such procedures as below strictly, or the filters would be damaged easily.
In-line Steam Sterilization Procedures:
1).Fully close the outlet valve, slightly open the inlet valve to adjust the steam pressure at 0.1-0.13 Mbar.
2).Slightly open the outlet valve and close that valve when steam begins to discharge, holding 30min at pressure 0.1MPa.
(Note: Do not fully open the outlet valve, or the mass steam would damage the filter by high temperature)
3). When sterilization line is complete, immediately introduce clear air or N2 into the system, keep the pressure at 0.02 Mpa above the steam pressure.
4). Holding until the temperature is below 100℃, increase the air pressure to cool the filter cartridge.
5). If the filter cartridge is too wet to be flowed through by steam easily , we need to evaporate the water in the filter first at low steam pressure, then increase to the requested pressure for sterilization when the steam release from the outlet valve.
a)Strictly control the steam pressure, keep it at 0.13Mpa when sterilization.
b)Steam used for sterilization should be free from condensation, which would flow through the membrane and damage it by high temperature.
c)Adequate means for condensate drainage should be employed to ensure steam is free from condensate in sterilization.
d)Cooling the filter system is the key step, an ideal way is to close the valves and maintain the pressure to cool naturally, or according to the above step 3. High pressure air and cold water are neither allowed to damage the filter cartridge by out of shape.
e)In sterilization, slowly adjust the outlet valve to control the differential pressure below 0.12Mpa.
f)The integrity test is necessary to assure the filter is undamaged after steam sterilization.