The blending of powders and granulates is a very important unit operation in the Pharmaceutical Industry. The Content Uniformity (CU) of each of the components which forms the blending is reached through this operation therefore, the next elaboration steps (compression, filling of capsules or pouches, etc.) can be carried out without any problem and the units have the appropriate content.
A standard blending process is conducted in two steps:
- In the first step the granulate or active is mixed with the excipients (diluents, binders, glidants, dyes, etc) and…
- In the second step the lubricant is added and the blending is extended for a few minutes more.
PLC with coloured touch screen panel.
Process edition by product.
Graphics outline.
Printing reports.
Automatic stop, in load and unload position.
According to GMP guidelines.
FDA - Compliance / 21 CFR part 11.
FAT – SAT – Validation documents.
The double cone blender DVC Pharma has been conceived considering the three main blending variables:
A) Geometry of the container.
B) Equipment filling or loading level.
C) Blending speed.
Powders with “Free flow” features can be blended for a certain number of revolutions (time, RPM) regardless of the chosen speed, while the blending of the “Cohesive” type must be blended at high speeds in order to improve the shear cut and blend of the components.
MIXING EXPERIMENTAL PROTOCOLS USING DVC Pharma:
“Curves of Mixed and variables that affect the Uniformity of Content (UC) of the actives in the mixing”:
a) Load level of the double cone
b) Rotation speed of the double cone
c) Flow characteristics of the formulations to mixing