Specification for on-line steam sterilization of sterilization filter

In the safe production of pharmaceutical technology, on-line steam sterilization is required for the terminal sterilization filter. Since a filter element unit is composed of different kinds of polymer materials, the high-temperature disinfection of the filter element should be strictly controlled according to the requirements, otherwise it will easily lead to the filter element. damage.

The online steam sterilization steps are as follows:

1. Close the outlet valve, slightly open the inlet valve, adjust the inlet steam pressure P0.1-0.13MPa

2. Open the outlet valve and see that the outlet valve is closed when the steam is emerging, and keep it at 0.1 MPa for 30 minutes.

(Note: Do not let the outlet valve be fully opened, so as to prevent the steam from flowing through the filter and causing high temperature steam filtration and damage to the filter element)

3. After disinfection, quickly fill the clean N2 or air to maintain the system pressure. The gas pressure is 0.02MPa higher than the steam pressure during disinfection.

4. When the system temperature is lower than 100 °C, increase the gas pressure and blow the filter element cold.

5. If the filter element is wet and the steam is not easy to pass through, the water in the micropores of the filter element should be evaporated out at a lower steam pressure. When the downstream steam emerges, the pressure required for disinfection is raised.

Precautions:

1. Strictly control the steam inlet pressure, the pressure holding value is controlled at 0.13MPa

2. Try to control the humidity of the steam. If the moisture content is too high, it may cause the high temperature water filtration membrane to damage the membrane pores.

3. During the sterilization process, the condensate should be drained through the filter drain valve to ensure that the high temperature water does not filter through the membrane.

4. Cooling of the filter, which is critical, it is possible to close the upper and lower valves for pressure-holding natural cooling, and is also an ideal cooling method, or follow step 3 above. Do not cool with high pressure air or use cooling water, which will cause the polymer material to shrink and deform.

5. During the disinfection process, pay attention to the opening degree of the outlet valve to prevent the pressure difference between the front and the back exceeding 0.12 MPa.

6. After the online steam sterilization, the integrity test of the filter element should be carried out to confirm the integrity of the filter.