The second is the fact sheet that follows with a series of bullet points divided by topic that list the advantages of isolation technology applied to regenerative medicine.
Future of ACT
More challenging applications in Advanced Cell Therapies
Increased number of laboratories, clinical groups and companies ready to jump in the clinical phase
Stronger manufacturing requirements addressed by GMP in cell-based preparations
Easier GMP Compliance with a Glove Box
GMP, Annex 1, (21) “The utilisation of isolator technology to minimize human interventions in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment.”
Higher safety with a Glove Box
Top class sterilization protocol of the critical areas using VPHP cycle
No manual intervention in environmental sanitization brings less risk of human errors
Better space management with a Glove Box
Smaller footprint of the classified areas allows a glove box to be installed in smaller facilities
A larger Class A space available, compared to the BSC used in the Cleanroom
Other Savings and Comparisons
Total sanitizing costs using a glove box: average cost of 1 L H2O2 cartridge is 7 Euro. Typical consumption is 1 cartridge per 5 cycles.
Average running cost of a glove box is one third of a small size clean room
No sterile gowning for operators needed with a glove box
Time savings for operators
Easier validation procedure with a glove box.
Comparable yearly validation costs and building costs.