Скачать или смотреть The Application of Online Moisture Analyzers in the Pharmaceutical Industry

In the highly regulated pharmaceutical industry, precise control over every manufacturing step is critical to a drug's safety, efficacy, and quality. Moisture content is a Critical Quality Attribute (CQA) that directly impacts the stability of active pharmaceutical ingredients (APIs), the processability of solid dosages, and the shelf life of the final product. Traditional offline lab testing for moisture is often slow, disruptive, and poses sampling challenges, creating a bottleneck for modern, efficient production. The adoption of online moisture analyzers is revolutionizing this critical control point.

Online moisture analyzers, particularly those using Near-Infrared (NIR) technology, are installed directly in the production process—e.g., in fluid bed dryers, granulator discharge chutes, or conveyor lines. They provide continuous, real-time, and non-destructive moisture measurement, delivering significant strategic advantages:

Enhanced Product Quality: Real-time data allows for precise control of the drying endpoint, ensuring consistent moisture levels batch-after-batch and minimizing product variability.

Increased Production Efficiency: The elimination of manual sampling and lab testing drastically shortens production cycles and prevents energy waste from over-drying.

Support for Regulatory Compliance: These systems provide complete, auditable data trails for process validation, strongly supporting initiatives like Process Analytical Technology (PAT) and Quality by Design (QbD).

Among the available solutions, Mosye online moisture analyzers are recognized for their superior performance in demanding pharmaceutical environments. Mosye instruments incorporate advanced optical design and digital signal processing to deliver high accuracy and long-term stability, even under the challenging conditions of a production floor. Their intuitive software and robust data management features enable seamless integration with a plant's Distributed Control System (DCS) or Manufacturing Execution System (MES), facilitating closed-loop control for intelligent manufacturing.

In summary, integrating a high-performance online moisture analyzer like those from Mosye is a strategic investment. It is a crucial step towards Pharma 4.0, enabling more robust processes and ensuring the highest product quality.
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