Unit Operation: Blending

The ePAT 602 Blend Monitor is a real time, NIRS based, continuous PAT analyzer developed specifically for the pharmaceutical industry. The system monitors the uniformity of all blend components such that end -point determination can be controlled and maximized. The ePAT 602 Blend Monitor also comprises an on-board processor allowing on board spectral storage and measuring head, connected via a rugged umbilical containing fiber optics.

The on board processor communicates with a remote computer, so that measurements can be viewed and recorded in real time. All data is recorded locally within the embedded electronics such that no data is lost in the event of a communication failure.

The measuring head is configured for convienent, non-contact analysis with a nominal 10mm, measurement area and a standard focal distance of 18mm.

The instrument is capable of measuring samples through a window, typically inserted into the lid of a blender bin and triggered by the blender's rotation.

A flush mounted window design can be manufactured and implemented by Expo Technologies on behalf of the client.

The system contains Diode Array-based NIR spectrometer.

The ePAT 602 can be directly installed onto existing blending equipment with minimal modification. It is easy to calibrate, install, and operate. Complete turn-over documentation is offered to assist with your validation.

Outline Specification of ePAT 602 Blend Monitoring System

Spectral Range 1100-2100mm
Resolution 5nm
Wavelength Accuracy < 1.0nm
Wavelength Reproducibility < 0.1 nm
Base Line Drift < 2mAU/Hr (across entire wavelength range)
Light Source Tungsten Halogen
Noise - Pk to Pk < 0.02mAU (across the entire wavelength range)
Data Acquisition Time 10ms
Power Hot swappable batteries - 6 hr operation
Optional 110/240VAC
Optional 12VDC
Sampling Interface Non-contact
Sampling Area 40mm spot size - other sizes available on request
Working Distance 18mm
Enclosure cGMP, IP65 and NEMA 4X
Weight (Enclosure) 9.2kgs
Weight (Batteries) 1.5kgs
Weight (Measuring Head) 1.1kgs
Size (Enclosure) 160h x 400w x 269d (mm)
Size (Measuring Head) 131h x 118w x 118d (mm)
Communication Wireless 802.11g with WPA security and an optional direct Ethernet connection

Triggering

Triggering measurement can be done in a couple of ways. The software can be set to make measurements as spectral criteria are met, or, the preferred method is to incorporate an optical trigger switch that can be bolted to the instrument or the blender. It is important that the robustness of this triggering device is characterized and understood. Expo Technologies' document 601-RR-18-0117-C Triggering Robustness (PDF).

Hot Swappable Batteries

Four batteries and mains charging system are supplied. Two batteries can be charging on the mains charger while the other two batteries are utilized on the ePAT601. Both the batteries and the battery charger have inbuilt charge indicator levels.

Having two batteries attached to the ePAT601 allows power to be hot swapped.

ePAT 602 Overview

  • Interchangeable measuring heads
  • Hot-swappable batteries
  • Embedded processor
  • cGMP, 21CFR11, IQ/OQ
  • Robustness documentation

ePAT 602 Photos

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