Specifications include, but are not limited to: 1.1The purpose of this Statement of Works (SOW) is to describe the TAMUS CIADMrequirements for a Commissioning, Qualification and Validation (CQV) contractor. Work will be performed in support of TAMUS CIADM’s Fill-Finish development at its Westinghouse facility to enable design, construction, qualification and validation of a Bio-Safety-Level-1 (BSL1) fill-finish operation capable of producing 1.25 Million vials per month. The CQV contractor will be responsible for advising TAMUS CIADM regarding the Architecture and Engineering (A&E) aspects of the facility design, and for performing and advising TAMUS CIADM regarding CQV tasks, as described herein.1.2The entirety of the TAMUS CIADM activity at its Westinghouse facility encompasses two (2) distinct components, all of which will share certain centralized utilities and services such aselectrical power, HVAC, water, security, etc. The 2 components are identified as:1.2.1Fill Finish Facility (subject of this SOW).1.2.2Process Development Lab (separate TAMUS CIADM initiative).1.3This SOW describes ONLY the requirements for the Fill Finish Facility. This includes the extent to which it integrates with centralized utilities and services.
