URS
DQ
FAT
SAT
IQ with calibration of critical components.
OQ
PQ which include:
pressure leak test, vacuum leak test, bowie dick test , vent filter sterilization test , 3 heat distribution test for empty chamber, 3 heat distribution test for each load(detect worst location), 3 heat penetration test with biological indicator challenge for each load.
Revalidation each year (one heat penetration cycle with BI for each load).