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Fit-for-Purpose Near Infrared Analyzer: MicroNIR™ PAT–W Spectrometer - For Quality-by-Design Manufacturing

Fit-for-Purpose Near Infrared Analyzer: MicroNIR™ PAT–W Spectrometer - For Quality-by-Design Manufacturing

The MicroNIR™ PAT-W spectrometer is a fit-for-purpose near-infrared (NIR) analyzer for quality-by-design (QbD) manufacturing. The spectrometer is a rugged, scalable, next-generation system for real-time process monitoring in blend homogeneity, loss on drying, content uniformity, compaction and other process analytical technology (PAT) applications. With proven Viavi linear variable filter (LVF) technology, the PAT-W has the smallest form factor in the process monitoring instrument market in a fit-for-purpose design. This makes it perfect for use with processing equipment of various sizes, with the stability and performance to enable efficient and smart manufacturing.

The user-friendly MicroNIR™ PAT-W was designed for today's demanding GMP-regulated environments yet requires marginal system maintenance. There are no moving components or expensive fiber optic cables, thus enabling excellent instrument stability and performance in harsh process environments. Its stainless steel/brushed aluminum cabinet resists water and dust to IP67 standards and cleans easily.

Key Features

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

Applications

Pharmaceutical Manufacturing

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

Food and Feed Manufacturing

  • Nutritional assay
  • Moisture content
  • Fat
  • Protein

Industrial Processing

  • Polymers
  • Reaction monitoring
  • Petrochemicals

MicroNIR Software

The software suite allows for positioning flexibility from process/product development to manufacturing environments and features audit trails, encrypted secure data storage, comprehensive user management and a number of other capabilities needed for regulated GMP environments.

  • The MicroNIR PAT control software enables easy data acquisition, instrument performance qualification per USP 1119 criteria, technique investigation, technique development, user management and the visualization of moving block standard deviation (MBSD) trends
  • Viavi Unscrambler® X Lite regression and classification software offers a full 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 various process techniques from different MicroNIR spectrometers. Process Engineers can easily monitor collected data and trend results in real-time with simultaneous output of key process data to the plant control system.

Mounting and Process Integration

The MicroNIR PAT-W has been built with highest flexibility in mind to meet the numerous different criteria for process integration. It adds into a process three different mounts:

Standard

This includes a weld in base flange, a sapphire window, a 2” sanitary (hygienic) flange mount 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 window, sanitary flange mount and retaining ring are assembled. The PAT-W with an adaptable collet then secures against the window and a sanitary flange using a standard tri-clover clamp (or C-clamp). All pieces can be taken apart for easy cleaning and maintenance.

Threaded

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

Standard mount

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

Specifications

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

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