Glove Box vs Cleanroom: are Glove boxes better than Cleanrooms in Advanced Cell Therapy Applications?
Glove boxes, or Isolators as we call the next generation of glove boxes, are often not used because organizations are not aware of their advantages versus standard cleanrooms.
We have prepared two tools that can help you compare and decide.
The first is this infographic with a side-by-side comparison of the two technologies:
The second useful tool is this list of Key Facts related to this topic, which lists the advantages of isolation technology applied to regenerative medicine.
KEY FACTS
Future of ACT
- More challenging applications in Advanced Cell Therapies are coming
- Increased number of laboratories, clinical groups, and companies ready to move to 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 utilization 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
- The 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 a 1-liter H2O2 cartridge is 7 Euro. Typical consumption is 1 cartridge per 5 cycles.
- The average running cost of a glove box is one-third of the running cost 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.
