MicroNIR PAT-W

A fit-for-purpose near-infrared (NIR) analyzer for quality-by-design (QbD) manufacturing

The MicroNIR™ PAT-W is a battery-powered rugged NIR spectrometer equipped with WiFi connectivity for data communication making it suitable for use on rotating blenders as well as other stationary process equipment.

MicroNIR PAT-W

The MicroNIR PAT-W spectrometer is a fit-for-purpose near-infrared (NIR) analyzer that is meant for quality-by-design (QbD) manufacturing. The spectrometer is a sturdy, scalable, next-generation system for real-time process monitoring in blend homogeneity, content uniformity, loss on drying, compaction, and other process analytical technology (PAT) applications. With the well-established Viavi linear variable filter (LVF) technology, the PAT-W has the smallest form factor among commercial process monitoring instruments in a fit-for-purpose design. This makes it ideal for use with processing equipment of a variety of sizes, with the stability and performance to facilitate efficient and smart manufacturing.

The user-friendly MicroNIR PAT-W was engineered to handle today's challenging GMP-regulated environments yet requires minimal system maintenance. There are no expensive fiber optic cables or no moving components, thus enabling superior instrument stability and performance in challenging process environments. Its stainless steel/brushed aluminum cabinet is water and dust resistant according to IP67 standards and cleans easily.

Key Features

The key features of the MicroNIR PAT-W spectrometer are as follows:

  • Non-destructive, non-invasive, and real-time near-infrared analysis
  • User-selectable Ethernet or Wi-Fi for data communication and system control
  • User-replaceable, rechargeable Li-ion battery with over eight hours of uninterrupted run time
  • Integrated PC enables fast and secure store and forward of gathered spectral data
  • Incorporated multi-axis triggering
  • Trigger options for a variety of applications: internal orientation timer, push button and external
  • Real-time moving block standard deviation (MBSD) and %RSD analysis for end-point determinations for granulation, blending, drying, and coating processes
  • Washable, IP67-rated enclosure

Applications

The main applications of the MicroNIR PAT-W spectrometer are as follows:

Pharmaceutical Manufacturing

  • Blend uniformity
  • Content uniformity
  • Fluid bed drying
  • Granulation

Food and Feed Manufacturing

  • Moisture content
  • Nutritional assay
  • Protein
  • Fat

Industrial Processing

  • Polymers
  • Petrochemicals
  • Reaction monitoring

MicroNIR Software

The software package allows for positioning flexibility from process/product development to manufacturing environments and offers audit trails, comprehensive user management, encrypted secure data storage, and several other capabilities required for regulated GMP environments.

  • The MicroNIR PAT control software enables instrument performance qualification per USP 1119 criteria, easy data acquisition, technique investigation, user management, technique development, and the visualization of moving block standard deviation (MBSD) trends.
  • The Viavi Unscrambler® X Lite regression and classification software provides a complete set of chemometric tools for calibration model development and data analysis, supporting MBSD model development with % RSD and PCA-based blending tools
  • The MicroNIR Process software is programmed for easy process monitoring of a variety of process methods from different MicroNIR spectrometers. Process engineers can easily monitor gathered data and trend results in real-time with concurrent output of important process data to the plant control system

Mounting and Process Integration

The MicroNIR PAT-W has been designed with maximum flexibility in mind to meet the many different criteria for process integration. It incorporates into a process three different mounts.

Standard

This includes a weld in base flange, a 2” sanitary (hygienic) flange mount, a sapphire window, and a retaining ring with O-rings. The base flange is welded into a hole cut in the lid of a blender and then the sanitary flange mount, window, and retaining ring are assembled. Next, the PAT-W with an adaptable collet is secured against the window and a sanitary flange using a standard tri-clover clamp (or C-clamp). All pieces can be dismantled for easy cleaning and maintenance.

Threaded

The threaded mount allows a user to weld a mount into the process equipment and then link the PAT-U using the threaded tip of the spectrometer. This mount also has a removable window to allow easy cleaning and maintenance.

MicroNIR PAT-W
MicroNIR PAT-W

Standard mount

When used on a rotating blender, the PAT-W has an integrated nine-axis inertial measurement unit (IMU) that consists of a three-axis gyroscope, a three-axis magnetometer, and a three-axis accelerometer. The IMU enables highly accurate and repeatable triggering of the PAT-W.

MicroNIR PAT-W
MicroNIR PAT-W

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Technical Specs

Parameter

Specification

Illumination source

Two integrated vacuum tungsten lamps

Bulb life

>40,000 hours

Illumination geometry

Flood illumination/ 0° observer

Input aperture dimensions

2.5 x 3.0 mm

Sample working distance

0-15 mm from window

Dispersing element

Linear variable filter

Detector

128-pixel InGaAs photodiode array

Pixel size/pitch

30 µm x 250 µm/50 µm

Wavelength range

950 – 1650 nm (10,526 – 6060 cm-1)

Pixel-to-pixel interval

6.2 nm for 950-1650 nm

Spectral bandwidth (FWHM)

<1.25% of center wavelength (1% typical) (for example, @1000 nm, resolution is <12.5 nm)

Analog-to-digital Convertor

16 bit

Dynamic range (max)

1000:1

Measurement time (typical)

0.25 – 0.5 second

Integration time

10 ms typical, minimum 10 µsec, maximum limited by dark signal

Computer interface

TCP/IP Cat5 Ethernet 802.11 g WiFi

Spectrometer weight

Less than 1.4 kg (3 lb)

Size

160 mm x 136 mm x 136 mm
(6.3 in x 5.37 in x 5.37 in)

Power

Battery: 7.5 V @6.4 Ah for >8 hr run time
External: 110-240 V AC

Data format

Encrypted, Unsb, CSV, and SPC output

Operating system

Windows 8.1, 8, and 7

Software available

MicroNIR PAT, Unscrambler X Lite, MicroNIR Process

Operating temperature

0 – 40 deg C (non-condensing)

Enclosure

Stainless steel and aluminum: dust and waterproof, sealed and cleanable to IP67 standard

Trigger

Internal 9-axis IMU, external 24 V input

Mounting

Adaptable stainless steel tri-clover mount