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A gentle PAT approach to on-line control of the lyophilization process.

Author(s) : GALAN M., VELARDI S., PISANO R., et al.

Summary

A lyophilization process is usually only specified in terms of a 'recipe' (shelf temperature and chamber pressure vs. time). According to the recent PAT guidelines, there is the need to study in depth the lyophilization process in order to develop in-line tools to enable better monitoring and control. In this work an advanced MTM approach, called DPE (dynamic parameters estimation) is first presented, based on a complex mathematical model. In alternative, the "smart vial" is proposed, a Kalman filter based observer allowing an almost continuous monitoring without probes physically inserted into the product. Results obtained in a small industrial prototype equipped with the DPE-based LyoDriver control software, are presented. The software is capable to determine the optimal shelf temperature, ensuring the fastest drying time without overcoming the maximum allowable product temperature. Finally, the two complementary monitoring systems, the DPE and the "smart vial", are combined in an even more robust control system.

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Pages: 2007-3

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Details

  • Original title: A gentle PAT approach to on-line control of the lyophilization process.
  • Record ID : 2008-2751
  • Languages: English
  • Source: New Ventures in Freeze-Drying
  • Publication date: 2007/07

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