The MicroNIR enables quality by design (QbD) principles to be adopted in batch and continuous pharmaceutical manufacturing processes. Manufacturer JDSU explains how its small, cost effective innovation is rewriting the rules for spectroscopy.
Many of the regulatory agencies around the world, including the United States Food and Drug Administration (FDA), have emphasised applying QbD principles to the developing and manufacturing of pharmaceutical products. QbD, along with online, at-line, and in-line process analytical technology (PAT) tools, leads to a greater understanding of the process and the product. This enhanced understanding enables systematic and scientific process-control strategies and instant process feedback, as well as continual knowledge-building of processes themselves. The benefits are considerable and include higher quality, improved consistency, reduced development and manufacturing costs, and faster regulatory approval.
Near-infrared (NIR) spectroscopy is one of the PAT tools that can be used at various stages of process manufacturing, from raw material verification, moisture content monitoring in drying processes, and end-point monitoring in blending to active-ingredient tablet assay. Conventional NIR spectrometers tend to be expensive, bulky and designed with Czerny Turner grating-based systems, or Fourier-transform technology in mind. Fourier-transform infrared technology, in particular, requires high precision and costly mechanical components.
Additionally, many of the existing NIR spectroscopy instruments are designed for a range of purposes, and exceed the needs of specific applications, increasing capital investment costs, while their large size often limits their utility on existing process installations.
Smaller, cheaper, better
North California-based JDSU is a global public company that specialises in thin-film coatings and optical systems, and has six decades’ experience designing, developing and manufacturing optical products for anti-counterfeiting, defence, consumer and analytical instruments.
JDSU has developed the world’s smallest NIR spectrometer with the highest performance-to-price ratio. The MicroNIR weighs less than 60g and measures less than 50mm in diameter. It is used as an online and at-line tool for process development, transfer and monitoring and control. It relies on high performance, reliability and linear variable filter (LVF) technology as the dispersing element. The latter is an inorganic thin-film optical coating deposited on a glass substrate mounted over a diode array detector that separates incoming light into individual wavelengths
The MicroNIR integrates the light source and readout electronics. The MicroNIR 1700 covers the wavelength range of 950-1,650nm, while the MicroNIR 2200 covers 1,150-2,150nm.
The MicroNIR small footprint and cost-effectiveness make it ideal not only for batch processes (fluid bed dryers and granulators, for example), but also for the new continuous manufacturing processes that require multiple NIR sensors across various points. Optional external IP65 housings made of stainless steel, with sapphire windows, are available to place the spectrometer inside the enclosure. The MicroNIR can be mounted directly on the window of a blender, a fluid bed dryer, or any other process without the need for costly fibre-optic probes. Other sampling interface options are also possible.
A new approach to QbD
The MicroNIR PAT is battery-powered and equipped with user-selectable wireless (Wi-Fi or Bluetooth) or Ethernet connection for data communication and is the smallest product of its type. It weighs less than 1.5kg, is housed in IP65 housing and complies with cGMP requirements. While it has been designed to be used for end-point monitoring on a rotating blender, it is suitable for other processes. The MicroNIR family is offered with intuitive user-interface software and the ability to build classification and regression NIR models, perform real time prediction, or continuously monitor specific parameters.
The MicroNIR offers the highest return on investment to companies looking to adopt QbD. It has been adopted by R&D scientists, PAT engineers and QC managers for raw material identification, moisture monitoring on tray and fluid bed drying, ribbon density on roller compactors, API concentration on tablet-press feed frames and end-point monitoring on blenders. The MicroNIR redefines how NIR spectroscopy can be used, from cost-effectiveness, to simple installation and ease of use.
