Pharmaceuticals and cosmetics
How to optimize production quality and ensure that every product consistently meets specifications?
Pharmaceutical and biopharmaceutical development and manufacturing is becoming increasingly complex and expensive. The need for more elaborate material characterization and tighter quality control requirements combined with tighter time constraints place considerable demands on analysis. Benchtop X-ray fluorescence (XRF) is a rapid non-destructive analytical technique which can reduce analysis time providing higher throughput leading to lower costs and a shorter time to market.
Current good manufacturing practice (cGMP) and FDA 21 CFR Part 11 legislation require original data to be secure and user actions to be traced (audit trail). The Epsilon benchtop instruments with the enhanced data security software are the ideal solutions for enabling operation in highly regulated environments. With our Epsilon benchtop instruments we offer a wide variety of applications to help optimize your product quality.
Residual catalyst analysis
Do you need to control for residual catalyst metals as part of ICH Q3D or USP<232>?
Catalyst metals including ruthenium (Ru), rhodium (Rh), palladium (Pd), iridium (Ir) and platinum (Pt) can remain during the production of active pharmaceutical ingredients (APIs). The Epsilon benchtop instruments offer non-destructive, rapid and easy quantification of catalyst metals at levels required by ICH Q3D and USP<232>.
Foreign particle and raw material identification by FingerPrint
Do you encounter unexpected foreign particles in the production line?
The Epsilon benchtop instruments using Fingerprint can help identify foreign particles and raw materials from different suppliers. The software module uses advanced algorithms of principal component analysis (PCA) and cluster analysis. This is useful for distinguishing small changes in the quality of the raw material, without the need of elemental concentrations as input.
Elemental impurity determination
Do you need to control elemental impurities in pharmaceutical products?
Pharmaceutical legislation including USP<232/233> and ICH Q3D stipulates a number of elemental impurities that are required to be controlled in pharmaceutical materials, like Pb, Hg, As and Cd. The Epsilon benchtop instruments offer non-destructive, rapid and easy quantification of a number of trace elements at the levels required by governing bodies.