It is a centrifugal processing of single unit operation.
The process involves the deposition of successive layers of an active compound onto nonpareil seeds resulting in the formation of uniform size pellets.
The operation is carried out using a Drug layering rotating plate, Dry powder dusted on nonpareils adheres, increasing their size and forming larger pellets. As per requirements.
Growth occurs by a process of blending of powder / liquid binding and consolidation. After liquid addition and dusting creates the correct diameter pellets, then tumbling of the coalesced aggregates increases their sphericity.
The requirements of process validation or Good Manufacturing practices (GMP) are simplified as the complete spheroid production process is restricted to a single processor, min. size possible 200 microns.
Setup and Preparation:
Purge Air: First, we blow air to clear out any particles that might get stuck between the layering plate and the drum.
Load Granules: We place the initial small granules (called starter granules) onto a rotating plate.
Powder Feeder: We put the powder we will use into a funnel that feeds it onto the granules.
Solution Tank: We prepare the liquid solution that will help the powder stick to the granules.
Start Rotation: We start the plate rotating at the speed we need.
Layering Process:
Wet Granules: While the plate is spinning, we spray the starter granules with the liquid solution.
Add Powder: At the same time, we dust the granules with the powder. This helps the powder stick to the wet granules.
Build Up Layers: As the granules keep getting wet and dusted with powder, they start to grow in size.
Shaping and Discharging:
Tumbling: The growing granules are tumbled around to help them form a more rounded shape.
Discharge: Once they reach the desired size and shape, they are automatically pushed out of the machine through a door that opens. The finished granules fall into a collection hopper.
Control System:
Electrical Panel: An electrical control panel or touchscreen (HMI panel) manages the whole process, adjusting settings and ensuring everything works smoothly.
In summary, this process involves rotating a plate with starter granules, spraying them with a liquid, and dusting them with powder. The granules grow larger and become more spherical as they rotate and are treated with the liquid and powder. Once they are the right size and shape, they are discharged into a collection container.