Program Covington: Automation & MES CQV Commissioning, Qualification and Verification

Blood Plasma Therapeutic

Overview

Shire (now part of Takeda) built a 100-acre greenfield campus in Covington, Georgia. The campus includes over 1.1 million square feet of building space that was built to manufacture human plasma-derived drug substances and dosage form products. The site includes facilities for plasma testing, fractionation, formulation and filling, packaging, warehousing, central utilities, administration, and laboratory facilities.

Sequence Scope

Sequence was responsible for developing a science and risk-based validation plan to facilitate efficient turn-key qualification of automation systems complete with a phased C&Q approach to accelerate system release. The scope included development and execution of functional testing to demonstrate the continuous and batch operations responsible for controlling clean utilities and process systems were fit for intended use per user and functional specifications.

The effort consisted of more than 100 protocols executed in both online and offline testing environments on virtualized DeltaV networks consisting of 63 control panels, 9 Charms I/O panels, 155 field panels, 137 solenoid panels, > 1,500 junction boxes, and ~17,500 I/O. In addition, Sequence was responsible for qualification of the Electronic Batch Management System on a Siemens XFP platform.

Sequence supported the risk assessment process to identify critical aspects and associated automation control strategies.

The project was successfully executed on time and within budget, received FDA approval, and received the ISPE Facility of the Year Honorable Mention Award in 2019.

Takeda

Covington, GA

Blood Plasma Therapeutic