Recommendations for Risk-Based Microbial Testing of Cell Therapies Based on Type of Containment
| Manufacturing Environment | Containment System | In-Process Monitoring | Final Product Microbial Testing |
|---|---|---|---|
| Biological safety cabinet in a classified area | Open | Yes | Yes |
| Closed | No | Yes | |
| Barrier system in a classified area | Open | Yes | Yes |
| Closed | No | Yes | |
| pen isolator system | Open | Yes | Yes |
| Closed | No | Yes | |
| Closed isolator system | Open | Yes | Yes |
| Closed | No | No | |
| Gloveless, robotic, isolator system | Opena | NA | NA |
| Closed | No | No |
↵a Open systems would not be used in this environment.