無菌プロセスアイソレータシステムにおける環境モニタリングプログラム策定のためのグリッドプロファイリングと気流可視化調査を活用したリスクアセスメント手法の研究

抄録

Our group has studied the procedure for the development of a unified risk assessment and environmental monitoring program in aseptic process isolator systems, based on the grid profiling approach (BioPhorum's Approach). We adopted the REM/I-REM approach for risk assessment in grid profiling and incorporated airflow visualisation studies into this. The purpose of airflow visualisation studies is not only to assess qualification, but also to develop a product/process contamination control strategy based on a risk assessment that takes into account the results of the study.