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Importance and shape of pilot scale-up of homogeneous emulsifying machine


Release time:

2019-07-11

When the laboratory process of chemical pharmaceutical process research is completed, that is, after the drug process route is determined by demonstration, it is generally necessary to go through a pilot scale amplification that is 50-100 times larger than the small test scale, so as to further study the change law of reaction conditions in each part of a certain scale device and solve the problems that have not been solved or found in the laboratory stage. A certain number of samples are also needed in the development of new drugs for clinical trials and for drug testing and sample retention. According to the size of the drug dose, the length of treatment, usually need 2-10kg quantity, which is difficult to complete the general laboratory conditions. Determine process path

When the laboratory process of chemical pharmaceutical process research is completed, that is, after the drug process route is determined by demonstration, it is generally necessary to go through a pilot scale amplification that is 50-100 times larger than the small test scale, so as to further study the change law of reaction conditions in each part of a certain scale device and solve the problems that have not been solved or found in the laboratory stage.
A certain number of samples are also needed in the development of new drugs for clinical trials and for drug testing and sample retention. According to the size of the drug dose, the length of treatment, usually need 2-10kg quantity, which is difficult to complete the general laboratory conditions.
After determining the process route, each step of chemical synthesis reaction or biosynthesis reaction will not change significantly due to small-scale, pilot scale-up and large-scale production conditions, but each step zui good process conditions, with the test scale and equipment and other external conditions may need to be adjusted.