TABLE X

Assessment of Process Equipment Hazard

HazardSub-FactorsDescription and ReasonWeighting/Score
Equipment severityFixedThis factor weights fixed equipment in the cleanroom as a greater risk than mobile equipment in the cleanroom. This is based on mobile equipment more often being directly sanitized or autoclaved prior to use and therefore this would be given a lower weighting than equipment that is permanently housed in area and thereby more likely to be exposed to the general environment.1
MobileThis factor weights fixed equipment in the cleanroom as a greater risk than mobile equipment in the cleanroom. This is based on mobile equipment more often being directly sanitized or autoclaved prior to use and therefore this would be given a lower weighting than equipment that is permanently housed in area and thereby more likely to be exposed to the general environment.2