Modern Lyo Cycle Optimization
“Hot” and “Cold” Spot Determination by Wireless Real-Time Temperature Measurement as Process Analytical Technology (PAT) Tool
Verfahrenstechnik
Key Words Lyo cycle | Critical positions | Process control | Product temperature | Critical product parameter
Abstract
Traditional lyo cycle development leads to a predetermined program that usually is subject of process validation. As a consequence this cycle needs to be applied for the fabrication of the product under all circumstances. If for any reasons e. g. only a part of a total batch size can be manufactured, no adaptations are possible, i. e. the shortening of the cycle is not allowed due to regulatory compliance.
This article demonstrates a new conceptual design to the development and modern validation of lyo cycles applying process control by determination of Product Temperature (TP) in critical positions (“hot” and “cold” spots) which allows for adaptation of the lyo cycle. Furthermore usage of these positions in development scales during scale-up and routine production is shown.
Korrespondenz:
Dr. Andrea Weiland-Waibel, Explicat Pharma GmbH, Georg-Knorr-Str. 4, 85662 Hohenbrunn;
e-mail: a.weiland@explicat.com
 | Dr. Andrea Weiland-Waibel Dr. Andrea Weiland-Waibel is Managing Director, QP and founder of Explicat® Pharma GmbH and expert in CMC project management. She is a frequent lecturer and holds several patents in pharmaceutical development, GMP-related subjects and lyo formulation and previously was Head of Pharmaceutical Technology at Pfizer. Explicat Pharma has been assigned several projects in relation to lyo products applying the modern process validation approach, including lyo cycle |
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