Extract Technology’s Cell Therapy Isolators are designed to provide an ergonomic and practical alternative to traditional clean rooms for stringent cGMP and international regulations for the production of cells for clinical use.
The utilisation of isolator technology...
to minimise human integration in processing area results in a significant decrease in risk of microbiology contamination from the environment within the aseptically manufactured products. The air classification required for the background environment depends on the design of the isolator and its application. It should be controlled and for aseptic processing it should be at least grade D/ISO 8.
Isolator systems will be custom designed to suit individual customer requirements but will generally include the following;
Main advantages of Cell Therapy Isolator compared to traditional Cleanroom operation: