Purpose: The efficacy of hydrogen peroxide and peracetic acid as isolator sterilization agents was compared. Results: In an efficacy test conducted with an empty isolator, the sterilization time ...
Isolators move into smaller-volume processes, including cell and gene therapy manufacturing. The use of isolators for aseptic manufacturing has increased, driven by the effectiveness of the equipment ...
A comparison of conventional cleanrooms, restricted access barrier systems, and isolators, shows the benefits of using isolators in high-potency drug manufacturing. The use of isolators has grown with ...
Validation of the sterilization cycle guarantees material sterilization. In daily use, bacterial load is not checked after each sterilization cycle. Our system allowed us to monitor contact time, ...