Client Goal

To complete the process validation effort in a timely and accurate manner.

Project Overview

The facility consists of small scale and large scale production trains supported by a common media and buffer preparation area.  Each production train consists of a cell culture area with progressively large bioreactors, followed by centrifugal separation, chromatographic purification, ultra filtration and formulation.

At peak utilization, the paper-based quality system required augmentation by electronic (computerized) tracking systems to manage the large number of documents and activities.

The process control system is based on the Rockwell platform with 35 ControlLogix PLC’s, RSViewSE HMI’s, RSBizWare Batch and OSI Pi Historian.  The majority of the control software was developed following a SP88 batch software architecture. 

Scope of Supply

Tegron was among a number of teams subcontracted to provide software validation support services.  Tegron provided nearly one year of software validation services for Client at their facility.

The Outcome

Project was completed on time and under budget.