Pharmaceutical manufacturing process

Wet chemical and spectroscopic methods for process monitoring

Pharma process monitoring

Powerful in-process analysis

Reliable analysis results are determined directly in-process with the latest methods of ion analysis and spectroscopy: measurement of pH value, conductivity, redox potential, (Karl Fischer) titration, photometry, ion-selective electrode measurement, ion chromatography, voltammetry, and near-infrared and Raman spectroscopy.

We are your inline, online, and atline analysis specialist with more than 40 years' experience. A broad program of process analyzers and sample preparation systems for a large array of applications in the pharma industry is awaiting you.

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The real-time approach: NIRS

Tablet production
PAT and QbD – with NIRS in search of the best of all methods

The FDA's stated goal is to cut development time for new drugs while at the same time significantly improving quality. This requirement can only be fulfilled with analytical techniques which monitor the entire process – from incoming raw materials throughout the process to final inspection. To achieve this, perfect PAT sensors are needed that enable "live" tracking of the manufacturing process. NIRS is the technique that makes this possible. An inline sensor monitors product quality in real time. This prevents out-of-spec products and reduces overall costs.

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Eye on the process: Granulation and drying

NIRS analysis: moisture vs. time
Reduction of the water content in a pharmaceutical powder over time

A key manufacturing process in the pharmaceutical industry is the granulation and drying process for powders that precedes tablet manufacturing and makes it possible to press powders into tablets in the first place. NIRS is the method of choice for determining the reaction endpoint when pressability is at the optimal point. Probes in the drier or granulator make it possible to track the process in real time. This reduces the process duration and thus increases the drying and granulation capacity of the system. At the same time, it minimizes the deviation from the required setpoint values. For the determination of the water content, the calibration model uses Karl Fischer titration as reference method.

Webinar: NIRS

Tablets on book page
A PAT tool from raw material identification to process monitoring

Implementation of FDA’s PAT and QbD initiatives involves monitoring and controlling critical process parameters. NIRS is one of the most promising PAT tools. This webinar shows how to implement NIR for raw material and process control testing as well as for examination of final products.

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Further applications and products

NIRS XDS Analyzer

NIRS XDS Process Analyzer

Discover the NIRS XDS Process Analyzer. This online spectroscopy system allows you to monitor the manufacturing process in real time and on up to 9 measuring channels. With a scan range from 800 to 2200 nm, this analyzer is suitable for a wide range of applications. The NIRS XDS Process Analyzer is the perfect tool to avoid out-of-spec products and implement the FDA's PAT initiative.

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Detail of an industrial plant

Process Analytics Applications

We have compiled 40 years of our experience in process analysis control into one handbook. This volume contains all applications that we have sold to customers from various industrial fields, such as chemical and petrochemical, semiconductor, power, pharmaceutical, automotive and aerospace, and many more.

Download the applications handbook