TABLE V

Assessment of Processing Hazard

HazardSub-FactorsDescription and ReasonWeighting/Score
Processing severityOpen processingThis factor considers processing where the product is exposed for x amount of time to be a greater risk where processing is taking place, but the product remains sealed for the duration of the activity (for example, a sealed vessel wheeled into a temperature-controlled for processing and then wheeled out again).2
Closed processingBased on the above assessment, closed processing is a lower risk activity than an open processing activity.1
Nonprocessing roomsRooms that are not used for processing but are captive to the process area, and therefore have cleanroom status through being connected to a particular air-handling system. However, these rooms have no direct impact to the process although the risk of possible carry-through of any surface contamination from a non-process room to a process area remains. This risk is considered to be relatively small, therefore a low weighting is given.0