Manufacturing Facility

Salas O’Brien executed commissioning activities for a clean room installation. We collaborated with facility subject matter experts (SMEs) and the construction contractor to develop and execute commissioning test plans. Our team maintained a site presence throughout the construction and commissioning phases to support adherence to good engineering practices (GEP) and to prepare for qualification of current good manufacturing practices (cGMP) systems.

We documented commissioning of thirty-two air handling units and all associated HVAC utilities. We led the 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 United States Pharmacopeia (USP) Water and clean compressed air serving the International Organization of Standardization (ISO) production areas. Our thorough process delivered safe and functional systems to the end-user, with formal checks performed for both critical and indirect impact systems.