Immediate use BUD (Any storage condition)
4 hours
Category 1 Room Temp BUD
12 Hours
Category 1 Refrigerated BUD
24 hours
Category 1 Frozen BUD
N/A
Category 2 Room Temp BUD
1-45 days
Category 2 Refrigerated BUD
4-60 days
Category 2 Frozen BUD
45-90 days
Category 3 Room Temp BUD
60-90 days
Category 3 Refrigerated BUD
90-120 days
Category 3 Frozen BUD
120-180 days
Immediate-use environment
Uncontrolled (no PEC)
Category 1 Environment
ISO 5 PEC in SGA
Category 2 Environment
ISO 5 PEC in cleanroom
Category 3 Environment
ISO 5 PEC in cleanroom with additional requirements