INTRODUCTIONThe shape, size and size distribution of the pharmaceutical solids particles, are the three principal factors that can affect primarily the fluency of a mix and so have a bearing on the dosage operations as are the compression and filling of capsules.
They can also affect other unitary pharmaceutical operations as the wet granulation of high shear mixer, since the changes in the size of raw material particles are converted in changes on the surface and the volume of the agglutinating liquid and the end point (torque) of the process are modified.
Also the size of the particle of the actives has a great incidence over the speed dissolution.
Particle size reduction, grinding or calibration, are some of the denominations that are given to an important stage in the manufacture of solid pharmaceutical products which has as an objective: “Reduce and standardize the size and affect the shape of the soild particles of raw material and dry or wet granules”
From the launching of high shear granulators (MIC) to the pharmaceutical market by means of which you get firm granulated products, it was necessary to use the Conical Screen Mills (CSM) with the capacity of reducing the particle size of strong granulated material, offering size uniformity, short time process and minimum heat development.
The calibration of the granulated material using in the conic calibrator produced the impact and cutting chamber and an impeller which is turning round at high speed tangentially towards the holes of a selector screen or cone (see figure 1). The conic mill calibrator CPS Line has been manufactured with the purpose of offering higher calibration versatility, in such a way that a great variety of goods could be calibrated with the highest accuracy required. CPS versatility is due to the possibility of 5 controllable variable combination, in a unique configuration for each type of material to be calibrated:
1- Impeller speed.
2- Impeller shape.
3- Size and shape of the selector cone holes.
4- Distance between the impeller wall and the selector cone wall.
5- The total area of holes in the selector cone.
Each of these 5 variables will affect on the features of the obtained calibrated material in different ways.
Keeping 4 constants of the 5 variables and changing the fifth one, you could see a change in the features of the obtained calibration in accordance with the following general rules:
– The impeller speed increase or reduction will reduce or increase the medium size of the obtained calibration, respectively.
– The flat side face impeller shall produce finer granules than the round face impeller.
– The cone hole size and shape shall determine the particle medium size and its shape.
– The impeller-cone distance shall affect the medium size.
– The total biggest opening area of the cone shall give the lower proportion of fine granules.
EXPERIMENTAL CALIBRATION PROTOCOLS
Using CPS Line
Impact and cutting chamber: the impeller turning
round at defined speed, impacts the particles
impelling them tangentially and forcing through
the screen holes.
Separator washer defines the distance between the
screen wall and the impeller.
Using the same cone, impeller, separator washer and cone opening area, the increase of the impeller turning speed determines smaller particles sizes.
Dry coarse granulate shows amplitude PSD centered at 2300 microns. After calibration in CPS Line PSD range is reduced and centered at 400 microns.
The cone mill calibrator CPS Line, allows accurate control of parameter of milling process of size reduction or solid particles calibration of raw materials, dry or wet granules.
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