Transfer of ready-to-use sterilised product primary packaging containers and single-use systems into small batch filling systems in isolators

摘要

This article considers methods of transfer of ready-to-use sterilised product containers for aseptic filling in small batch isolators. Ready-to-use containers are typically in nests/tubs with protective packaging that requires removal on entry to filling isolators. Two types of transfer method are considered: type 1, with an automated outer packaging decontamination process just before entry into the filling isolator, e.g. electron beam, low pressure/temperature plasma and hydrogen peroxide vapour; and type 2, mechanised de-bagging and no-touch transfer with a manual outer packaging disinfection step. The information provided aims to assist a risk-based selection process of the ready-to-use container transfer method.