MicroNIR Spectrometers enable pharmaceutical CDMO & nutraceutical industries to implement QbD/PAT. Unique MicroNIR Solutions fit all stages of your production cycle, increasing process control while reducing manufacturing costs.
NIR Sensor Solutions for PAT, QbD and CM Applications
Pharmaceutical manufacturing is demanding. The need to diligently protect patient health and well-being is always primary, but the obligations of USP and EP compliance can push manufacturers into costly and time-consuming processes that complicate the mission. In response to that challenge, scientists and process engineers have been migrating traditional batch-processing of drugs to leaner methods and, increasingly, to continuous or semi-continuous processes. Key to all these trends is PAT – Process Analytical Technology – to increase quality and productivity and gain critical process insights that inform additional innovation.
Batch processing typically depends on frequent laboratory analysis to assure quality at each stage of the manufacturing process. The laboratory analysis of raw materials, intermediates, and finished products, commonly defined as Quality by Testing (QbT), is time-consuming, carries many low value-added steps, and does not always prevent material waste. By contrast, in a Quality by Design (QbD) environment, raw materials are qualified directly in the receiving area; dryers, granulators, and mixers are equipped to continuously monitor moisture content and particle size of intermediates; blend uniformity is verified in real time with no need for systematic thief sampling; and tablet presses monitor the consistency of the powder flow before compression. PAT assures that the final product is as intended, requiring periodic lab analysis only for confirmation and fine-tuning the PAT calibration. Read on to learn how Near Infrared Spectroscopy (NIRS) can improve every phase of solid dose manufacturing and form the cornerstone of a systematic Quality by Design (QbD) implementation.