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The negative pressure weighing hood fully reflects the objective regulations and requirements of the

日期:2024-04-26 15:52
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摘要:Article 52 of the new version of GMP: The weighing of raw and auxiliary materials of preparations should usually be carried out in a specially designed weighing hood. Generally speaking, the weighing process of the preparation workshop is carried out in a separate weighing hood. Considering the dust problem, the weighing hood is generally straight row! In this case, fifty-two requirements have been met, but many companies still buy the negative pressure weighing hood separately. Is it a lot of w
Article 52 of the new version of GMP: The weighing of raw and auxiliary materials of preparations should usually be carried out in a specially designed weighing hood. Generally speaking, the weighing process of the preparation workshop is carried out in a separate weighing hood. Considering the dust problem, the weighing hood is generally straight row! In this case, fifty-two requirements have been met, but many companies still buy the negative pressure weighing hood separately. Is it a lot of work? In fact, it is necessary for the company to purchase the negative pressure weighing hood separately. If it is only scattered When weighing materials, it is not necessary to open the negative pressure system of the entire weighing hood, the weighing hood is enough. In addition, if some materials are easy to agglomerate and need to be sieved for pretreatment, the function of the negative pressure weighing hood is reflected. In addition, the negative pressure weighing hood can also remove the dust on the weighing personnel.

     Article 53 of the new version of GMP points out: The dust-producing operation room (such as the sampling, weighing, mixing, packaging and other operation rooms of dry materials or products) should maintain a relatively negative pressure or take special measures to prevent dust from spreading. Cross-contamination and easy cleaning. EU GMP guidelines require: Weighing of starting materials usually takes place in a weighing hood that is isolated and designed for use. China's pharmaceutical GMP guidelines believe that large dust will also be generated during the weighing process, and contamination and cross-contamination should be avoided to the greatest extent possible. It is recommended to operate in an area equipped with a dust removal system. From the requirements for weighing raw and auxiliary materials, it can be seen that the weighing of raw and auxiliary materials must meet the following requirements:

(1) There is a special weighing cover;
(2) There are measures to maintain relative negative pressure or special isolation;

(3) There is a dust removal system

      In the production process, the negative pressure weighing hood is not linked. In the general air conditioning system of the clean workshop, the air conditioner of the clean workshop is the guarantee of the environmental temperature and humidity control in the normal operation of the clean workshop. While the weighing hood with negative pressure is separate,