Manufacturers in the chemical and pharmaceutical industry must comply with GMP regulations, which place strict requirements on hygiene, premises, maintenance and calibration of equipment, documentation and traceability of measurement results. They must also ensure that the measurement technology does not compromise product quality and safety.

The guidelines further require that the PAT measurement system, in particular the spectrometer, is compatible with 21 CFR Part 11, which regulates electronic systems in FDA-regulated industries. The measurement interface must contain only FDA-approved materials and must ensure sufficient accuracy in the determination of impurities in the process.

Due to the highly flammable nature of the organic solvent, the measurement technology must also be suitable for use in an ATEX zone 1.

At the end of a distillation process, the end point release is monitored. Various impurities are measured in the process, so far only offline. As part of a joint project, a process analytical technology for this application is being developed and implemented to optimize the process, particularly with regard to compliance with environmental regulations and to save energy and process time. The aim is to improve process control and increase the number of daily batches produced.