Use of Experimental Design for the Characterization of a Depyrogenation Machine

Abstract

Depyrogenation tunnel are used in pharmaceutical filling lines to sterilize glass containers before they are aseptically filled. These tunnels use unidirectional hot air at temperatures up to 350°C and can be used to sterilize and depyrogenated glass vials and glass containers. The experimental design presented in this project describes the performance qualification activities process in the dry heat depyrogenation tunnel at worst case conditions ensuring the integrity of the HEPA filters. The parameters considered were: belt speed, temperature and endotoxin reduction. The parameters identified after analyzing the measurement are to be improved by applying DMAIC methodology from Six Sigma. Key Terms - DMAIC, experimental design, performance qualification, HEPA filters.