Key Characteristics
-Flexible technology for standard wet granulation, melt granulation, pelletizing or effervescent production, combined with vacuum or microwave drying
-Swinging bowl options during vacuum drying results in an improvement of the granule characteristics and a reduction in drying time
-Easy and efficient cleaning (CIP)
-Compact technology – reduce space requirement by incorporating several processing steps into one machine
Definition
A single pot processor is a high-shear mixer-granulator that is also equipped with drying technologies. Thus, single pot processing is the production of pharmaceutical granules using a wet granulation process in which dry mixing, liquid addition, wet granulation, drying and sizing of the granules is done in one machine.
Main Benefits
-By integrating granulating and drying capabilities into a single unit, capital investment in equipment and good manufacturing practice (GMP) floor space is lower than other alternatives.
-The number of material handling steps is decreased: consequently, the total processing time is shorter while maintaining a high yield and keeping production support to a minimum. At the same time also the number of required operators is reduced.
-Environmental variables, such as humidity, are eliminated from the manufacturing process, which may offer advantages for processing moisture-sensitive formulations.
-Requirements for solvent recovery systems are lower for single-pot processors compared with fluid bed dryers.
-Reaching a high level of containment is easy by application of the correct measures at in- and outlet valves.
-A single pot can be changed over in less than 2 hours, which makes it a very attractive technology if a large number of different products- demanding a high number of product changeovers- has to be produced.
Applications
-Contained production of highly active of toxic products
-Effervescent production
-Wet granulation using organic solvents
-Multiple product facilities requiring fast change-over
-‘special’ applications (e.g. melt granulation, crystallization onto substrates)
