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Sie suchen in allen Bereichen nach dem Autor Weiland-Waibel A.
In der Rubrik Zeitschriften haben wir 2 Beiträge für Sie gefunden
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MerkenWireless Temperature Measurement in Lyo Process Development, Validation and Production
Rubrik: Originale
(Treffer aus pharmind, Nr. 05, Seite 719 (2019))
Wireless Temperature Measurement in Lyo Process Development, Validation and Production / Weiland-Waibel • Wireless Temperature Measurement · Weiland-Waibel A · Explicat Pharma GmbH, Hohenbrunn
Critical Formulation Temperature (CFT) Product Temperature (T P ) Critical Product Parameter (CPP) Wireless Temperature Measurement (WTM) Process Performance Qualification (PPQ) Continuous Process Verification (CPV) It is known that the product temperature (T P ) is of utmost importance in freeze drying as T P is a critical product parameter, which determines the important critical product quality attributes (see table 1) such as physical appearance, residual moisture, storage stability, reconstitution time, etc. T P cannot be controlled directly, but is influenced by shelf temperature, chamber pressure, product resistance and various other factors such as super cooling, environment, etc. T P must ...
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MerkenModern Lyo Cycle Optimization
Rubrik: Verfahrenstechnik
(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 ...
