PAT Realization of an automated release process for the recovery of solvents

Implementation of an online measuring system for measuring impurities in solvents

Solvents are indispensable in industry and are used in large quantities in the chemical and pharmaceutical manufacturing processes. By recovering and reusing them, companies can significantly reduce their waste disposal costs, lower their environmental impact and save on the cost of new solvents. Corresponding processes, such as distillation, are therefore widely used in these industries. To ensure product quality, impurities in the solvent must be precisely measured after cleaning and transmitted to the process control system. With the aim of being able to optimally control his process, increase process reliability and increase efficiency, an international manufacturer of active ingredients switched from offline to an online process analytics solution for process monitoring.
 

The spectroscopic process analytical solution comes from Hellma Solutions

Development and implementation of an ATEX-approved, GMP-compliant NIR measurement system for determining the endpoint of a distillation process

Working together with the customer, the team from “Hellma Solutions”, the business unit for the provision of process analytics solutions, developed an online analytical measurement system that communicates with the process control system in real time and under GMP conditions via OPC UA. In addition to the metrological solution, the project scope also included extensive support for the pharmaceutical customer with the user requirement specifications (URS), the comprehensive GMP documentation and the validation concept. The project scope also includes the annual maintenance of the spectrometer and adjustments to the chemometrics as needed.

The advantages

Optimum process control:
Thanks to the use of online measurement technology, measurements can be carried out in real time and with high precision, and the process can be optimally controlled. By determining the exact end point, efficiency can be increased and energy costs minimized.

Ensuring product quality:
The online measurements with the “Excalibur FCP HD” are characterized by high precision and excellent reproducibility. The measuring optics are made of sapphire, the surface of which reduces the accumulation of particles.

Compliance guaranteed:
The measurement cell and the spectrometer comply with all GMP requirements. The material certificates confirm the FDA conformity of the materials used.

Worry-free:
Annual maintenance of the spectrometer and adjustments to the chemometrics as required guarantee reliable measurement results in the long term.

Application Note

Do you have a specific metrological challenge and need advice from our experts?
Analyze processes, identify solutions and weigh up alternatives. Together with our customers, we develop a wide range of metrological solutions. Get in touch and find your nearest contact person!