quality, Qualit├Ąt, Microverunreinigungen, micro impurities, PAT, Process Analytic Technology, Raman Spektroskopie, Raman spectroscopy, Quality by Design, QbD,

In-line Detection of Micro Impurities

Micro impurities play a roll

In the highly regulated pharmaceutical sector, the FDA guidance documents on Good Manufacturing Practices, Process Analytic Tool (PAT), and Quality by Design (QbD) changes the way they do function. PAT is a technique that detects any process diversion, which cannot be detected with discrete gauges, like temperatures, pressures, or flow rates. PAT is utilized as a feedback loop or to test systems adjusting the process in real- time enabling a high-quality product. Thus, obtained data are in accordance with the principle that quality cannot be tested, but should rather be built into the product.

Utilizing PAT

Industrial processes with demanding requirements for maximal purified processing water, air, gases ensure highest product quality. Modern and complex lab equipment measures these impurities. Such devices are At-Line, are used for different analytic tasks, and are slow in delivering quality process data. More efficient is to set up a measurement In-Line to ensure a constant, reliable production quality and to adapt in a dynamic manner process deviations.

Rascope’s solution

Our tailored solutions based on non-contact hyperspectral measurement ensure highest production quality down to micro particles. If a process monitors in-line proteins, water, hydrogen, or any other gaseous substance at critical process stages, the data are used to actively control the process. Thus, production is consistent, reliable and at lower cost.

Your benefits at a glance:

  1. Reliable, stable production process at lower cost
  2. No sample preparation necessary
  3. Insensitive to water
  4. Monitoring on trace levels