The Aeromatic-Fielder™ Granulator control system can be supplied with standardised or bespoke SCADA interfaces, utilising software, such as iFIX™ from GE Fanuc Automation, to provide data collection, management and recipe driven processes, fully compliant with FDA 21 CFR Part 11.
In order to ensure safe, efficient operation of the Granulator, the system is controlled through an industrial computer HMI, with all functions deriving from a PLC controller. This design allows the control interface to be completely washed down during product changeover. Furthermore the HMI may be upgraded to allow processing with flammable organic solvents, in an ATEX Zone 1/21 area. Completing the ATEX Zone 1/21 upgrade, flammable gases may be prevented from entering the controls enclosure in the base of the Laboratory PMA-Compact™ machines by purging with compressed air.
The physical safety of the operator is assured with the use of safety locks and proximity sensors to prevent access to the bowl and discharge when the equipment is operating. Binder addition and end point determination may be controlled through the HMI, manual control or fully automated, recipe control for the unit. Data acquisition can be delivered through a 21 CFR Part 11 compliant, on-board data capture device recording critical parameters throughout the process and allowing information downloads through an Ethernet connection.
End-point control
A choice of automated end-point control facilities, with trending for process optimization, is offered with all of the system control options - manual as well as PLC-based. Options include fixed process time, automatic end-point control based on power consumption, and a high-accuracy torque-based system. Both the power- and torque based options can be used to optimize spray rate and wet massing time, for faster, more uniform granule growth. It is also possible to control in-line the growth of the granules with FBRM.
Granulation comparison
Insoluble active
Granulation graph showing the improvements gained in a straight walled vessel when using the M8 impeller, include reduction in binder solution, reduced granulation time and enhanced end-point definition.
PAT integration - Lighthouse Probe Technology™
GEA Pharma Systems (GPS) has joined forces with J&M Analytik AG to create a compact and cleanable in-process optical probe for use in powder processing equipment.
The result is the novel LighthouseProbe™, which can be used with a range of spectroscopic techniques, including NIR and UV/vis, to overcome the traditional problem of product sticking to observation windows.The probe is compact and easy to installand makes it possible to take a reliable in process measurement of quality critical product characteristics including:
- Material and active content identification
- Active content uniformity during high shear blending operations
- Moisture content and end-point during drying processes
- Coat growth during coating processes
Optical methods such as UV/Vis or NIR spectroscopy can be very powerful tools for analysing a range of product characteristics, but in processes involving wet and sticky powders it is necessary to ensure that the system has a clear view of the product. Conventional windows used in process equipment such as fluid bed systems or high shear granulators, have always suffered from the risk of window fouling. The Lighthouse Probe™ has overcome this problem.