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    Home > Active Ingredient News > Drugs Articles > The negative pressure weighing hood fully reflects the objective provisions and requirements of the new version of GMP

    The negative pressure weighing hood fully reflects the objective provisions and requirements of the new version of GMP

    • Last Update: 2022-10-01
    • Source: Internet
    • Author: User
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    Negative pressure weighing hood fully reflects the objective provisions and requirements of the new version of GMP Article 52 of the new version of GMP: The weighing of raw materials and excipients of the preparation 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 inline! In this case, fifty-two requirements have been met, but many companies still buy negative pressure weighing hoods separately, so is it troublesome? In fact, it is necessary for enterprises to purchase negative pressure weighing hoods separately, if it is only a scattered weighing point material, there is no need 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, the need for sieve pretreatment, the role of the negative pressure weighing hood is reflected, and the negative pressure weighing hood can also remove the dust
    on the weighing personnel.

    Article 53 of the new version of GMP points out that the dust production 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 the spread of dust to avoid cross-contamination and facilitate cleaning
    .

    EU GMP Guidelines: The weighing of starting materials usually takes place
    in an isolated and purpose-designed weighing hood.

    China's drug GMP guidelines believe that large dusts will also be generated during the weighing process, and pollution and cross-contamination
    should be avoided to the greatest extent.

    It is recommended to operate in an area equipped with a dust removal system, from the requirements for the weighing of raw materials and accessories, it can be seen that the weighing of raw materials and auxiliary materials needs to meet: (1) There is a special weighing hood; (2) There are measures to maintain relative negative pressure or special isolation; (3) There is a dust removal system in the production process of negative pressure weighing hood is not linked, in the clean workshop of the total air conditioning system, clean workshop air conditioning is the clean workshop normal work of the ambient temperature and humidity control guarantee
    .

    The negative pressure weighing hood is separate, in the weighing process there is a vertical unidirectional air flow from top to bottom, from top to bottom to take away the dust, to prevent cross-contamination, is an independent auxiliary measure, can also be considered as an independent dust removal device
    .

     
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