Phase III Clean Room Installation

The Salas O’Brien GMP Commissioning and Validation Team was tasked with executing commissioning activities for the Phase III Clean Room Installation Project at the Pall Manufacturing Facility in Duncan, SC. This 100,000 sq/ft project involved the development and execution of commissioning test plans and cases in collaboration with facility SMEs and the construction contractor. The team maintained a site presence throughout the construction and commissioning phases to ensure adherence to Good Engineering Practice (GEP) and to prepare for qualification of critical or cGMP systems.

The commissioning scope encompassed the documented commissioning of thirty-two air handling units and associated HVAC utilities, certification of environmental conditions in forty-five ISO 7 and ISO 8 production and packaging rooms, and the commissioning of GMP critical utilities such as USP Water and clean compressed air serving the ISO production areas.