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Can vibrating screen be shared?

Writer: admin Time:2020-10-16 14:18 Browse:

A factory produces three kinds of oral solids of traditional Chinese medicine and material is extracted by water and then dried. Afterwards, dried extract is granulated, sieved by vibrating screen, mixed with appropriate amount of magnesium stearate and finally compressed to tablets. Since the extract is extracted by water, it is convenient and easy to clean equipment after production. And no problem is raised during cleaning verification. But as we all know, ingredients of traditional Chinese medicine preparations are pretty complex and we cannot determine the percentage of ingredient residue. Therefore, in the GMP follow-up inspection, the inspector doubts about the feasibility of common use of the screen.
 
However, why can vibrating screen not be in common-use while other equipment (including the equipment for extracting, drying, granulating, mixing, compressing, coating and blister packing) can.
 
In fact, the inner surface of equipment is clean and smooth. But the screen is so uneven that some material might remain on it. Besides, the screen meshes of these machines such as grinding machine or sieving machine are micro. It’s difficult for inspector to sample and for operators to clean. Also, different from the inspection for chemical drugs, there is no clear inspection and analysis procedure for traditional Chinese medicine. Anyway, it is not laborious to use one special screen for one machine. So it is suggested to manufacturers to use special screens, just like that special filtering bags are used for fluid bed drying of different medicines.

 Vibrating Screener
In GMP, screen management are stipulated as follows:
1) Manage screen receiving, providing, cleaning and using strictly;
2) Establish screen inspection records and formulate corresponding inspection procedures;
3) Formulate cycle for inspection of screen and handling measures to broken screens;
4) Store screens specially and classify them depending on their mesh;
5) Make sure that the screen is not broken and store it in dry and enclosed container depending on its specifications;
6) Check the screen before installation and usage to avoid any rupture;
7) Operate the machine at constant speed to avoid screen rupturing;
8) Stop operation, change the screen and handle it as an error for screen rupturing or medicine leaking;
9) Check the completeness of the screen after production and handle any rupture as an error;
10) Formulate procedures for screen cleaning and disinfection;
11) Clean and disinfect the screen again if it is used beyond the clean verification period.
 
 

 

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