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GRANULATION CPP

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 Critical process parameters (CPPs) in granulation, whether wet or dry, are those that directly impact the Critical Quality Attributes (CQAs) of the final granules, such as particle size distribution, bulk density, and flowability. These parameters need to be carefully monitored and controlled to ensure consistent and desired granule properties.  Key CPPs in Granulation: General Granulation: Impeller/Rotor Speed: Affects granule size, density, and uniformity by influencing mixing intensity and particle interactions.  Chopper Speed: Controls the size reduction of granules during the granulation process.  Granulating Solution Addition Rate: Influences granule growth and homogeneity by controlling the liquid binder distribution.  Massing Time: Impacts granule growth, density, and strength by controlling the duration of mixing.  Moisture Content: Crucial for granule formation and stability, affecting flowability and compressibility.  Drying Temperature and...
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PHARMA KNOWLEDGE PROFESSOR BHUPESH SOLANKI

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  Skip to content Most Frequently Asked Pharma Interview Questions 1.What is the definition of SOP?  SOPs are detailed written instructions for the operations routinely performed in the course of any activities associated with pharmaceutical manufacturing.  Or  A written authorized procedure which gives instructions for performing operations not necessarily specific to a given product / material, but of a more general nature the equipments preventive maintenance and cleaning; recall of products; purchasing; cleaning of premises and environmental control; sampling and inspection etc.  Or  These are guidelines which describe how the activity is to be performed. To achieve uniformity of results by each individual, it is mandatory to follow these guidelines. SOP is like a “TELL and SHOW” concept.  Tell – means to establish and teach how the activity is to be carried out.  Show – means to provide the documented proof for the activity carried out. 2. Wh...
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