Uploaded by BECTOCHEM1978 on Jul 28, 2011
GRANULATION: "A physical and chemical process where by small particles are gathered into larger, permanent masses in which the original particles can still be identified." Also, known as the most complex and difficult process to control during manufacturing.
CONTAINMENT:
"Pharmaceutical material, Personnel and the environment surrounding them forms the basis of any manufacturing facility in Pharmaceutical Industry. And the containment is the isolation of the first of these components from the other two."
CONTAINMENT STRATEGY FOR GRANULATION MACHINES:
The closed loop systems link mixing, fluid bed drying, sieving, milling and blending together.
This yields several benefits.
Reduces Dust, improving house keeping
Reduces Transfer Handling and product loss
Improves worker safety
Quality and consistency
Integrated line consisting of High Shear Granulator and Fluid Bed Dryer is the most advantageous of all, because it combines the most efficient granulator with the most efficient dryer to achieve high output can be realized. Additionally the high shear granulation process avoids any issues with material separation which can be challenging when micronized APIs are used. Another advantage is
the robustness of the granulation process which allows, for example, the opportunity of compensating for fluctuations in raw material quality by adjusting the process parameters, hence felicitating consistency. This option also requires the use of a high quality, high-shear granulator liquid. This avoids subsequent problems with uneven drying and extended time needed for the
milling of the granules after drying.
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