Real-time monitoring of the moisture content in different type of dryers by NIR spectroscopy as a PAT tool
The Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives have been of interest for pharmaceutical manufacturing in the last years. Implementation of PAT/QbD approach involves monitoring and controlling critical process parameters that influence the critical quality attributes of the product. One of the prime processes in pharmaceutical solid dosage form is granulation and drying process. With the PAT and QbD initiatives, the FDA aims to increase efficiency of the pharmaceutical production by real-time process analysis and control. Near Infrared spectroscopy (NIRS) is well accepted as a potential PAT analyzer due to its rapid and nondestructive technique that additionally requires no sample preparation.
Metrohm is well-established in determining the moisture content by Karl Fischer titration in every conceivable type of product. To provide advance solutions for pharmaceutical customers, Metrohm now is moving forward, bringing NIRS to help customers to optimize the use of raw materials and to consistently run production closer to target specifications with time- and cost-saving analytical techniques.
During this pharma webinar, we showed the use of NIR in the process that allows for monitoring low levels of residual moisture and other process constituents to yield better process control and endpoint determination.
What attendees learnt during this webinar:
- Developing robust and precise method
- Minimizing implementation efforts
- Ensuring calibration model transferability between analyzers.
Dr. Volker J. Frost (Head of Competence Center Spectroscopy, Metrohm NIRSystems)
Dr. Volker J. Frost is the head of the Competence Center Spectroscopy at Metrohm NIRSystems, Metrohm International Headquarters in Herisau, Switzerland. He got his PhD in Chemistry in the research topic of NIR spectroscopy, dedicating to chemometric software. After that, he has been working for 15 years in the NIR business.
Wim Guns (Chief Sales Officer, Metrohm NIRSystems)
Wim Guns is based in The Netherlands and has a degree in Chemical Engineering. He is Chief Sales Officer at Metrohm NIRSystems. In his role, he is responsible for NIR sales and second line support for all Metrohm daughters and distributors in Europe, Middle East, Africa, and Russia.
His first contact with NIR was in 1993 when he started at Perstorp Analytical as sales engineer for the Benelux focusing on the chemical and pharmaceutical market. After 20 years of involvement with NIR in the industrial market, he now uses his experience to grow the business for Metrohm.
Supported by Metrohm
Metrohm is one of the world’s most trusted manufacturers of high-precision instruments for chemical analysis. Metrohm was founded in 1943 by engineer Bertold Suhner in Herisau, Switzerland. Today, they are present in more than 80 countries with our own subsidiaries and exclusive distributors.
Find out more: www.metrohm.com