(Treffer aus TechnoPharm, Nr. 03, Seite 130 (2015))
Modern Lyo Cycle Optimization / “Hot” and “Cold” Spot Determination by Wireless Real-Time Temperature Measurement as Process Analytical Technology (PAT) Tool · Weiland-Waibel A · Explicat Pharma GmbH, Hohenbrunn
Lyo cycle Critical positions Process control Product temperature Critical product parameter Modern development following ICH Q8, Q9 and Q10 in the context of freeze drying is based on the objective to design a lyophilization cycle applying a systematic and scientific approach instead of trial and error. As described by Dr. Henning Gieseler [ 1 ] the coupling link between formulation and process is the physicochemical behaviour of the formulation resulting in a maximum allowable Product Temperature T P during drying. Product Temperature T P is of utmost importance in Freeze Drying as T P is a critical product parameter which ...