Two large air-handling systems providing air to an ISO 5 Sterile Filling Area were analyzed for reliability.
Fault Tree Analysis (FTA, graphic example at left) and Failure Mode and Effects Analysis (FMEA) were used to identify and quantify 53 different failure events. The goal was to address HVAC system shutdowns and issues with controlling cleanroom pressures.
G/BA’s report provided 23 recommendations for improving reliabiltiy and reducing lost-production-time events. Strategies ranged from modifying differential pressure sensors and adding vertical louvers for snow and ice protection, to a variety of controls adjustments and addition/replacement of equipment.
The client also received an equipment report card estimating condition and service life of existing equipment.