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 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

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
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

The spectroscopic performance of the ePAT611 for High Shear Wet Granulation is fully realised when combined with the ePAT611 Probe. This Diffuse Reflectance measurement probe is designed to withstand the rigours of the granulation process and can work in 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 which has been shown to significantly decrease window fouling problems. Full control of the probe together with the measured temperature readout is integrated into the latest version of NovaPAC© instrument control software. The ePAT 611 Probe umbilical is supplied in a standard 3m length. Custom lengths are available for a fully engineered PAT solution For all ePAT611 probe applications, Expo recommends the use of ePrecision.