A novel monitoring method utilizing a visualization system for fine particles to mitigate the risk of leakage from a containment isolator

Abstract

  When an isolator for the aseptic process controlled under a positive pressure is used for high potency drugs, both of the robust containment system and the operation procedure are required to setle aseptic and safety issues. In this article, a visualization system for fine particles is proposed as a useful tool to evaluate the leakage from the containment system such as an isolator. Application of this visualization system will allow the behavior of particles scattering to be so clearly detected as to lead to easier fixing of the monitoring point for leaked particles. The test results has shown that this newly developed method has exactly been proved to be effective for resolving the challenging leakage issue by using such a reasonable and systematic risk management tool.