PERFORMANCE

QUALIFICATION
By: Veryco Budianto
ISOLATOR
Aseptic Hold Time
Conducted in 3 days
Isolator and symbio pump in operational
state
Viable & non-viable parameter must be
conducted in day 0, 1, 2, and 3
Performance qualification is performed
after the equipment is turn on from off
mode
INCUBATOR & REFRIGERATOR
Heat distribution:
◦ Empty load
◦ Maximum load
Door Opening Recovery Test
Worst Case Study
AUTOCLAVE
Vacuum Leak Rate Test
Steam Penetration (Bowie-Dick)
Heat Distribution:
◦ Max load/Fixed load
◦ Min load/Empty load
Biological
Challenge Test
Chemical Challenge Test:
◦ Autoclaves tapes
WATERBATH
Heat distribution:
◦ Empty load
◦ Maximum load
Door Opening Recovery Test
Worst Case Study
OVEN
 BIOSAFETY CABINET

HEPA Integrity Test

Air Flow
PASBOX
Particulatetest
Microbiological test
Air flow test