In combination with the requirements of GMP for equipment and the characteristics of biological fermentation itself, the following conditions should be met when preparing the URS file of biological fermentation system equipment:
(1) Material requirements for equipment ( fermenter ). The material in contact with the culture medium (including the feed material), the fermentation broth (microorganisms, bacteria, vaccines, cells, etc.) must be made of a material that is non-toxic, corrosion-resistant, does not absorb the above substances, and does not chemically react with the above substances. . Often used materials are 316L, 304;
(2) The biological fermenter should be carried out under aseptic conditions for the whole biological culture. The tank should have a SIP process, so it should be in accordance with the "Steel Pressure Vessel" (150-1998) and "Steel Pressure Vessel Welding" during the production process. Regulations (JB/T4709-2000), "Non-destructive testing of pressure equipment" (JB/T4730-2005) and "Pressure Vessel Safety Technology Supervision Regulations" and other standards. At the same time, the inner surface of the fermenter should be smooth and free of dead angles to prevent accumulation of materials and easy to clean and sterilize after fermentation;
(3) The external parts of the biological fermenter should adhere to three convenient conditions, namely, installation and disassembly, cleaning and sterilization, convenient operation and maintenance, and can withstand high-pressure steam sterilization;
(4) The biological fermenter involves the active substance in the cultivation process, so it must comply with the biosafety standard, and it is necessary to prevent all external microorganisms from being polluted, and also to prevent the culture material in the fermenter from polluting the surrounding environment. Therefore, the biological fermenter should be a system device with good sealing performance, and the venting, discharging gas and liquid in the tank need to be filtered to remove the active material;
(5) The biological fermenter should have excellent mass transfer/heat transfer effect and excellent material mixing properties in order to provide the most suitable growth temperature for the culture. In the culture of animal cells, in addition to being able to fully mix well, it is necessary to not break the animal cells to ensure the smooth progress of the biological fermentation culture process.
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