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In the safe production of pharmaceutical process, online steam disinfection is required for the terminal sterilization filter element. As a filter element is composed of different kinds of polymer materials, the disinfection steps of the filter element at high temperature should be strictly controlled according to the requirements, otherwise the filter element will be damaged easily.
The online steam disinfection steps are as follows:
1. Close the outlet valve, slightly open the inlet valve, and adjust the inlet steam pressure p0.1-0.13mpa
2. Open the outlet valve slightly, and close the outlet valve when steam comes out, and keep it at 0.1 MPa for 30min
(Note: do not open all outlet valves to avoid high temperature steam filtration and damage to filter element due to steam flowing through filter element)
3. After disinfection, clean N2 or air was quickly filled to maintain the system pressure. The gas pressure was 0.02MPa higher than the steam pressure during disinfection
4. When the system temperature is lower than 100 ℃, the gas pressure can be increased to cool the filter element
5. If the filter element is wet and the steam is not easy to pass through, the water in the micropore of the filter element shall be evaporated at a lower steam pressure, and then the pressure required for disinfection shall be increased when the downstream steam is observed
matters needing attention:
1. Strictly control the steam inlet pressure and keep the pressure value at 0.13mpa
2. The humidity of steam should be controlled as much as possible. If the moisture content is too high, the membrane pore of high temperature water filtration membrane may be damaged
3. Ensure that the water is not discharged through the high temperature filter during the process of sterilization
4. The cooling of the filter is very important. The upper and lower valves can be closed for natural cooling under pressure. It is also an ideal cooling method, or according to step 3 above. Do not use high-pressure air cooling or cooling water cooling, which will lead to excessive shrinkage and deformation of polymer materials.
5. In the process of disinfection, attention should be paid to the opening degree of the outlet valve to prevent the pressure difference between the front and rear parts exceeding 0.12mpa.
6. After online steam disinfection, the integrity test of filter element shall be conducted to confirm the integrity of the filter.
