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.
Life Impact
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The Takeda state-of-the-art facility is providing much needed additional capacity for meeting increasing global demand for plasma-derived therapies. Ig is a critical treatment for primary immunodeficiency (PI) diseases in which part of the body immune system is missing or functions incorrectly.
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Manufactured drugs include FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN), Immuno Globulin. Source