On the Design of a Fuzzy Logic-Based Control System for Freeze-Drying Processes

J Pharm Sci. 2016 Dec;105(12):3562-3572. doi: 10.1016/j.xphs.2016.08.018. Epub 2016 Sep 28.

Abstract

This article is focused on the design of a fuzzy logic-based control system to optimize a drug freeze-drying process. The goal of the system is to keep product temperature as close as possible to the threshold value of the formulation being processed, without trespassing it, in such a way that product quality is not jeopardized and the sublimation flux is maximized. The method involves the measurement of product temperature and a set of rules that have been obtained through process simulation with the goal to obtain a unique set of rules for products with very different characteristics. Input variables are the difference between the temperature of the product and the threshold value, the difference between the temperature of the heating fluid and that of the product, and the rate of change of product temperature. The output variables are the variation of the temperature of the heating fluid and the pressure in the drying chamber. The effect of the starting value of the input variables and of the control interval has been investigated, thus resulting in the optimal configuration of the control system. Experimental investigation carried out in a pilot-scale freeze-dryer has been carried out to validate the proposed system.

Keywords: control; freeze-drying/lyophilization; fuzzy logic; optimization; process development; processing.

MeSH terms

  • Freeze Drying / methods
  • Fuzzy Logic*
  • Mannitol / chemistry
  • Research Design*
  • Sucrose / chemistry
  • Technology, Pharmaceutical / methods*

Substances

  • Mannitol
  • Sucrose