Implementing Automated Batch Control of a Biotechnology Manufacturing Facility using S88.01 concepts – A Case Study

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Genentech Inc. recently completed the design, construction and automation of a new, multipurpose, biotechnology drug, bulk-manufacturing facility in the United States. This project accomplished many first-time implementations for Genentech. This paper presents a case study discussing factors involved in the conceptualization of automation requirements and the challenges posed in designing and implementing them. Along the way, it highlights the efficiencies gained in using S88.01 principles of partitioning and modularity. Also addressed are the challenges posed to “Change Management” personnel involved in the startup, commissioning, qualification and validation of an S88.01 based system under the Good Manufacturing Practices guidelines of the Food and Drug Administration (FDA). It is Genentech’s desire to maximize plant output. To meet this goal, project teams are currently involved in devising schemes to ready the facility for a product changeover while the plant is in operation. The changeover involves some minor physical modifications along with control software changes. The challenges encountered and methods employed to meet them without compromising the Validated production environment of the control system will be highlighted.

Author: Chinmoy Roy, Senior Automation Engineer, Genentech, Inc; Geoffrey Wyshak, Senior Automation Engineer, Genentech, Inc.  | File Type: PDF

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