Pharmaceutical freeze-drying machine, also known as the pharmaceutical freeze-drying machine, pharmaceutical freeze-drying box sterilization of the lyophilizer methods mainly include steam sterilization, ethylene oxide sterilization and vaporizing hydrogen peroxide sterilization.
chemical sterilization method on pharmaceutical lyophilizer corrosion effect, but also easy to have chemical residues, affect the product quality.
Steam sterilization method using saturated steam albumin denaturation to kill microbes, the cell is a highly effective and reliable method, no pollution, no residue.
as a result, the pharmaceutical freeze-drying machine adopts high temperature steam sterilization.
The pharmaceutical in the sterilization of the lyophilizer (
SIP)
Is a key process to ensure the quality of biological products and pharmaceuticals.
In the sterilization is refers to the system or equipment in the original installation location do not make any moves steam sterilization.
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As shown in figure)
For the lyophilizer saturated steam sterilization SIP system of simple process, freeze-drying box wall, side panel, pressure device, the condenser inside, detection of original and related piping, valves, etc must be sterilized, so for the sake of their resistance to high temperature and high pressure.