Successful Large Volume Parenteral (LVP) Manufacturing Expansion and Upgrade?Triggers Additional Collaborations with Leading Medical Device Manufacturer of IVs

One hallmark of a great project team is the ability to effectively manage and mitigate risk. On a series of projects in Irvine, CA, to upgrade and expand B. Braun Medical Inc.’s Southern California LVP manufacturing facility, the DPR team faced a myriad of challenges associated with the technical complexities of the projects. Employing extensive preplanning, the latest laser-scanning and building information modeling (BIM) technology, and a highly collaborative approach, the team successfully completed its first two projects on site, and has begun work on a third.

The $20 million Water for Injection (WFI) Storage and Generation System Upgrade Project was designed to provide a robust, flexible, energy-efficient, cGMP-compliant and cost-effective automated purified water generation system that will be able to quickly respond to the changing production needs of one of the world’s largest producers of infusion therapy and pain management products. It will also allow for future expansion now that the 35-year-old facility has exceeded its expected life of 15-20 years.

DPR broke ground on the WFI upgrade project in March 2009. The project?scope included:

replacement of city feedwater booster pumps; three pretreatment trains; three 6,000 gph vapor compression stills; two 15,000-gallon storage tanks; interconnecting piping, pumps, and heat exchangers; all necessary instrumentation and controls for a fully automated system;
relocation of existing maintenance support areas;
handling all required installation, start-up and enhanced commissioning activities for this validated facility; and
the interface of the new generation and storage system with the existing WFI distribution system.
Extensive preplanning and collaboration among DPR, B. Braun, the architect, CRB Consulting Engineers, and key subcontractors began in preconstruction and continued through project completion in December 2009. That proved especially critical in overcoming one of the more formidable challenges that involved 40 utility tie-ins, with crews working around the clock during a three-day plant shutdown. The operation was carefully planned well in advance, down to the hour, and flawlessly executed.

The team performed another successful shutdown over Labor Day weekend, September 5th, tying three new lines into the existing facility’s validated WFI system. DPR was able to submit validation paperwork to B. Braun immediately upon completion—a process that typically takes weeks—enabling the company to continue production without any impact to its operation.

Another notable challenge, according to DPR Project Manager Rudy Olaguez, entailed replacing the facility’s four existing city water booster pumps—the “lifelines” of the facility—with three new pumps during normal operations. Once again, DPR accomplished this without any impact to plant operation. “There was an enormous amount of risk associated with that work, and it went without a hitch,” Olaguez said.

DPR’s work on the WFI project also included coordinating and managing the entire manufacturing equipment purchase and installation for the upgraded facility. Prefabrication played a major role in this process; some 75 percent of the piping and other materials were fabricated off site based on a detailed BIM model of the project. A complete laser scan of the building’s interiors helped ensure accurate information in the BIM model and aided with the prefabrication specifications. Vendors from Connecticut to Missouri shipped the prefabricated sections to the jobsite on modular skids for onsite re-assembly.

“This helped our schedule tremendously,” said DPR Project Engineer Justin Anderson. “It was amazing to watch the rigging of the pre-manufactured heat exchanger and process piping pump skids into place?below the 15,000-gallon storage tanks. These were shipped in four sections and were on individual skids, minimizing the amount of welding required in this highly congested area.”

The end result of the team effort is DPR’s completion of the WFI project months ahead of schedule and with substantial savings to the owner. “It was a very positive experience,” said Chris Herman, B. Braun’s project manager.

The success of that project led to the award of two additional projects to DPR: a $34 million construction project that includes a utility upgrade with renovation of utility systems throughout the facility and changeover of packaging lines. This project is currently underway with anticipated completion in mid-December.

B. Braun Medical Inc.

B. Braun is a leading manufacturer of infusion therapy and pain management products with an environmentally friendly focus. Guided by the company’s “Sharing Expertise” philosophy, B. Braun addresses the critical issues of infection prevention, medication safety and environmental responsibility by promoting best practices that help clinicians reduce medication errors, prevent healthcare-acquired infections and achieve sustainability objectives.

PROJECT HIGHLIGHTS:

• More than 40 utility tie-ins completed with minimal interruption to production and operations over a three-day plant shutdown period
• Streamlined validation process spared client unnecessary production interruptions
• Laser scans and BIM modeling permitted prefebrication of 75 percent of the piping and other materials
• Project completed months ahead of schedule and below budget