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Tools for Quality-by-Design Compliance

Viavi Solutions rolled out two new compact devices that enable on-the-spot inspection and real-time analysis of raw materials.

Tools for Quality-By-Design Compliance
Tools for Quality-By-Design Compliance

As part of the Food and Drug Administration’s current good manufacturing practice (cGMP), pharmaceutical companies must ensure the quality of drugs right down to the safety of the raw materials. That requires testing the chemical makeup of materials, and it typically means sending samples to a lab for inspection.

But now, as part of the move toward quality-by-design operations and a shift from batch manufacturing to continuous process, companies are looking for new ways to obtain real-time results.

Viavi Solutions, a provider of high-precision optics, is helping the effort by delivering two new tools as part of its ultra-compact spectrometer portfolio that enables pharma companies to obtain the analysis they need at the point of use in the field. The MicroNIR OnSite and MicroNIR PAT, announced earlier this month, are near-infrared spectroscopy devices that can simply point at an organic substance to quickly and accurately measure its material makeup while monitoring critical process parameters.

MicroNIR PAT (process analytical technology) is designed for real-time in-line monitoring of multiple points on batch or continuous manufacturing processes without the need for extensive capital costs or major reconfiguration of existing manufacturing processes. MicroNIR OnSite, a rugged handheld analyzer suitable for rapid and nondestructive analysis of raw materials, enables quality control managers in pharmaceutical, chemical—and even food manufacturing—to quickly accept or reject incoming material, as well as perform compositional testing and quality checks on products throughout the manufacturing process.

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