Cell Therapy Isolators

ALTERNATIVE TO TRADITIONAL CLEAN ROOMS FOR STRINGENT CGMP

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.

ISO Kinetic cone
Cell Therapy Isolator
Integrated Incubators

ENGINEERED ASEPTIC SOLUTIONS

Availability

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.

Design Advantages

IMPROVED STERILITY

ASSURANCE

Reducing contamination Increasing patient safety

FULL PROCESS

INTEGRATION

Customer propriety equipment fully integrated

Offering

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