life sciences Case Studies

Midwest Drug Co. Upgrades Chromatography System

A large Midwest pharmaceutical manufacturer partnered with TriCore to upgrade an existing chromatography system for their plasma fractionation process. This large-scale, fully validated system upgrade required software engineering for new chromatography columns and packing skid, conversation tanks, filtration system and all associated CIP systems. In order to provide a seamless transition between old and new, TriCore designed the new system to parallel the existing one. Overall scope for the project included appropriate GAMP compliance validation documentation for functional specification, software design specification and software acceptance test specification; software engineering for PLC and HMI equipment; business intelligence comprising data collection and more than two dozen validated reports; factory acceptance testing; site installation; and site acceptance testing.