Genzyme Train 4

Objective

Genzyme Train 4 was a $40M capital project to bring their BioRx production train online.

Equipment

Equipment supported included 2 new CIP skids, Chromatography Skids and new Columns, Cold Room, New HVAC units, new MF Harvest skid, new Buffer tanks, new CIP circuits, Sterile Media tank, Production BioReactor, Seed BioReactor, and Harvest tank.

Services

We performed system and component impact assessments and design qualifications, developed and executed final commissioning and qualification protocols and reports, executed SIP PQ protocols, system boundary assessments, FAT protocol generation and execution, and CIP cycle development.

Project Success

This project was originally scheduled October 2012 – January 2014.  However, our Project Manager reviewed the PV strategy and identified significant savings could be achieved by accelerating the schedule to allow for a single PV run utilizing the new BioRx train and the new purification suites. As a result, this project was completed 4 months ahead of schedule. We will look for ways to accelerate your project schedule as well.

Time Frame

11 months (4 months ahead of schedule)

Similar Projects