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Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture is the guideline for the validation of computer - aided systems in the pharmaceutical industry.


Good Manufact uring Practice means compliance with international production standards, e.g. the hygiene and documentation for the pharmaceutical industry.


Granulation is defined as the production of granules and free - flowing substances. Granulation as the basic operation in pharmaceutical solid production designates the agglomeration of powder particles. Granules are therefore agglomerates of primary particles.


Machine for the production of agglomerates. Agglomeration is a process of mechanical granule enlargement. Granulation can be implemented as wet, dry or melting agglomeration.


Granules consist of solid or coarse granules with each granule bei ng an agglomerate of powder particles. Granules can contain one or several substances.


Through mechanical forces, the size of the particles of solids is reduced. The Bohle Turbo Mill ( BTM 150) is a typical mill deployed in the pharmaceutical production.

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From Powder to the coated tablet: The unique feature of the production unit QbCon® is that the tablet production can be implemented either without granulation or with dry or wet granulation, in one system.

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