Unit Operation: High Shear Wet Granulation

The ePAT 611 High Shear Wet Granulation Monitor is a real time, NIRS based, continuous PAT analyzer developed specifically for the pharmaceutical industry. The system monitors water content and that of all blend components such that end -point determination can be controlled and maximized. The ePAT 611 Monitor also comprises an on-board computer and a remote measuring head with umbilical fiber optic and heated measurement probe sample interface in order to keep the measurement window clean once implemented into the granulation bowl. The device is designed to work in ATEX classified areas Zone 1, 21. The system includes an embedded computer which communicates with a remote base station computer, so that measurements can be viewed and recorded in real time. All data is recorded locally within the embedded computer such that no data is lost in the event of a communication failure.

The measurement probe can work under temperatures up to 250°C and pressures of up to 10 bar. The probe head can be heated to ±1°C between 30°C and 70°C.

The instrument is capable of measuring samples at the probe tip which is typically inserted through the wall of the granulator, but it may be configured to measure through the lid.

The system contains a Diode Array based NIR spectrometer module.

The ePAT 611 can be directly installed onto existing High Shear Wet Granulation equipment with some modification. Expo Technologies can undertake all implementation work. It is easy to calibrate, install, and operate. Complete turn-over documentation is offered to assist with your validation.

Outline Specification of ePAT611 High Shear Wet Granulation Monitoring System

Spectral Range	1100-2100 nm
Resolution	4nm
Wavelength Accuracy	<1.0 nm
Wavelength Reproducibility	<0.1 nm
Base Line Drift	< 2mAU/Hr (across entire wavelength range)
Light Source	Tungsten Halogen
Noise ( Pk to Pk )	< 0.2mAU (across the entire wavelength range)
Power	110/240VAC
Sampling Interface	20 mm diameter heated Range: 30-70°C Reproducibility: ± 1°C cGMP compliant, IP65
Sampling Area	5 mm²
Working Distance	At the outside surface of the probe window
Instrument Enclosure	cGMP, IP65, ATEX Category 2 Zone 1, Zone 21
Size (Enclosure)	800h x 450w x 350d (mm)
Communication	Wireless 802.11g with WPA security and an optional direct Ethernet connection
Computer	Embedded, ruggedized, removable flash memory

Umbilical Fiber Optic & Measurement Probe

A key part of this measurement device is the probe for the High Shear Wet Granulation Monitor. It can be configured in various lengths, but the standard configuration is a 3m long umbilical with 27 mm diameter. The diameter of the temperature controlled measurement probe is 20 mm. It can withstand temperatures of up to 250°C and pressures up to 10 bar. The probe window is heated with an integral heater contained within the spectrometer enclosure.