Cronimo: High Shear Mixer

Wet granulation involves mixing dry powders (consisting of excipients and active pharmaceutical ingredients) in a mixing vessel with a liquid binding agent. The action of the slowly-rotating impeller blade and the faster rotating chopper blade in conjunction with the liquid binder causes the wet mass to agglomerate into granules.

Since wet granulation is a batch process, the amount of material that can be processed in a given batch is dependent on the size of the mixing bowl. Cronimo’s line of mixer granulators come in a wide range of sizes, from 2 liter bowls (0.3-0.8 Kg capacity, depending on powder density) used in R&D and formulation development work, up to production units with a working bowl volume of 1,250 liters (approx. 600 Kg capacity.)

All product contact parts as standard are constructed of 316 Stainless Steel and and polished to a #7 mirror finish with a surface roughness of Ra. < 0.20u. Non-product contact parts are 304 Stainless Steel with a #4 finish.

The control systems available are dependent upon the customer’s specified level of system functional control and the sophistication level of data collection and analysis to be performed by the control system.

For formulation development purposes. The Cronimo Model MB5 High Shear Granulator is designed with a standard 5 liter bowl but has options for 2, 10 and 15 liter interchangeable bowls. The standard controls include a simple push button based system with variable speed chopper and mixer drives. The MB5 is provided with a cart with large wheels to provide mobility, safety and a convenient location for mounting the control cabinet and a variety of options that may be selected.

The Cronimo MB5 can be provided with a wide variety of mechanical options, such as bowl jackets, lighted bowl, liquid preparation system, heater/chiller units, vacuum loading, Stainless Steel filter housing and other features. Some of the options are not available on the 2 or 5 liter bowls due to size restrictions.

The Cronimo Production High Shear Granulators include the following bowl sizes: 25, 80, 125, 250, 400, 600 and 1000 liters. Each of these machines can be designed for “In-Room” construction or “Thru-The-Wall” construction for either non-explosion or explosion proof rated environments. The control systems selected can be very simple standard PLC-based pushbutton controls to a fully automated system using either Allen Bradley or Siemens based controls including a touchscreen HMI. A fully automated system can be offered in full compliance with 21 CFR Part 11 and GAMP IV, including the required documentation. All production sized granulators have available as an option the Cronimo TTM™ True Torque Measurement system for end point detection.