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The flooring in the entire department is coated with epoxy with a clear coat of
polyurethane in order to have an impervious microbe resistant floor. The walls of
entire department is treated with water base epoxy primer and finally with polyurethane
paint.
Positive air pressures are maintained in the air lock between the primary corridor
and granulation to ensure that outside air does not enter into areas.
Department is separated as per the process step.
Granulation section: Air supplied to granulation section is filtered
through 10µ filter and 5µ filter.
All machinery installed is made as per GMP Standards. Main equipments are 150 liter
SS 316 Jacketed Paste kettle, 36" SS 316 Vibro sifter, SS316 Communating mill having
300 kg capacity of pulverization, 600 liter Rapid mixing granulator with PLC, 600
liter Fluid bed dryer with PLC, 1800 liter octagonal blender.
This section is equipped
to take batch sizes from 100 Kg to 600 Kg.
Compression Section: To prevent cross contamination with granulation
section & Coating section it is separated with by positive air lock. Compression
Area having independent AHU, these are circulatory type through a bank of 10 µ -
/ 5µ and terminal HEPA filter .3 µ to achieve class 10000. Class 10000 is comprises
of air changes of 30 and particle count for viable and non-viable and DOP test,
10% fresh air is used. There is total 4 Nos of compression section. Presently 27
stn. D tooling, 35 stn. B tooling machine are installed
Coating section: Section is separated with positive pressure of
air with separate AHU's. 2 no. of 48" SS 316 coating pan are installed. SS 316 Jacketed
solution preparation tank is provided to prepare the solution between 50-100 ltr.
To make controlled release pellets 60 kg of SS 316 Pelletizer (Fluid bed coater)
is provide. Additional to maintain the GMP standard, process of loading of raw material
is done by IPC Lifter in every step. |
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