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;
- Ergonomic design generated with the aid of full scale mock-ups
- Multiple chamber arrangements providing defined barriers between process steps, enhancing aseptic performance
- Fully welded fabrications of 316L stainless steel, providing crevice free construction with internally radiused corners
- On-board recirculation laminar flow are flow system guaranteeing Grade A /ISO 5 classification
- Integration of proprietary devices e.g. RTP’s incubators, centrifuge and decontamination system etc.
- Integrated viable / non-viable systems
Main advantages of Cell Therapy Isolator compared to traditional Cleanroom operation:
- cGMP compliant design
- Increased sterility by reducing contamination risks (increased patient safety)
- Smaller operational space
- Reduced human interventions
- Physical barrier and pressure differential
- Hydrogen peroxide decontamination
- Highly controller material flow
- Full process equipment integration within grade A / ISO 5 environment
- Easier process separation (dedicated chambers)
- Different pressure regimes available within each chamber
- Full gowning not required