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In Defense of the Nation

In Defense of the Nation

In the wake of September 11, a dedicated Building Team delivers a smallpox vaccine processing facility in just 72 days

By By Renée Young, Contributing Editor | August 11, 2010
This article first appeared in the 200305 issue of BD+C.

Smallpox, a virus that once brought rampant illness, scarring, and death to millions, was eradicated in 1977, but the terrorist attacks of 9/11/2001 restored the threat of widespread contamination.

The Federal government responded quickly and, thanks to a dedicated Building Team who delivered a manufacturing facility in record time, the U.S. is now stockpiled with enough doses of vaccine to treat every American.

Those who participated saw the project as fulfilling a mission of the national defense. It was this determination that transformed an 80-year-old steel-fabrication plant into a 9,500-sq.-ft. structure complete with a biologically contained clean room in just 72 days. As the competition judges noted, the Building Team put aside their personal lives for the sake of the country.

Taking a huge financial risk, Baltimore, Md.-based Chesapeake Biological Laboratories (CBL) launched into construction so that it could be in position to deliver the vaccine should it win the Federal contract, which it eventually did — albeit not until several weeks after construction was underway.

On Nov. 1, 2001, CBL hired The Whiting-Turner Contracting Co., Baltimore, as GC/GM to provide a turnkey project. Senior project manager Richard (Rick) Ayd, Jr., brought on long-time collaborator O'Neal, Inc., Baltimore, as architect/engineer.

Over the next couple of days, the team held a design charette. Then, on Nov. 5, 2001, the entire force of some 35 people gathered at an all-day meeting to review the building's goals, design, schedule, and owner expectations. "We all knew we had a mission to accomplish, and the feeling in the room was of complete dedication to the goal of getting this project built on time," recalled O'Neal team leader Alan Brock. "It's a feeling that definitely was unique to this project."

While the project involved a fairly routine pharmaceutical manufacturing process — taking bulk quantities of frozen vaccine (produced by Baxter International, Deerfield, Ill., and a Canadian firm, Acambis), breaking them down into single doses, and filling the vials under sterile conditions — what was not known were the requirements for processing smallpox vaccine, which had not been in use for nearly three decades, nor the dangers involved. Given the urgency of the project, the U.S. Food and Drug Administration provided extensive staffing to help the team build FDA requirements into the plan. By the end of the first day, a basic facility diagram and an equipment list were complete.

The next morning, after a sleepless night, the design team presented the layout to CBL management, who threw the designers a curve. Instead of having a Level Two biological facility (as defined by the International Society of Pharmaceutical Engineers), the owners asked the designers for a facility that, with some modification, would enable Level Three containment in the future, should CBL get into production of other biological substances.

Undaunted, by lunchtime the Building Team had a plan that called for the redevelopment of the existing structure, construction of a 3,500-sq.-ft. addition for receiving and storage, and the use of an external trailer to house changing rooms and a testing lab. This required the addition of second-stage gowning and de-gowning rooms, the use of HEPA-filters on the exhaust side, and one-pass air instead of recirculated air.

Designed in just a day and a half, this structure, with only a few modifications, is what eventually would stand on a corner of the CBL campus. It would contain a Class 100 clean room (fewer than 100 half-micron particles per cubic foot of air) and be adaptable to making other demanding biological products once the smallpox vaccine production was completed.

Where a day equals a week

"Trust, respect, and flexibility were essential to this project's success," says O'Neal's Brock. "We didn't have time for anything but full cooperation, since the project had several twists and turns that would have bunched up any normal project for weeks, and maybe months." On a project where a day equaled a week and a week a month, the Building Team adopted innovative approaches to permits, construction documents, design limitations, and procurement challenges. "We did whatever it took to keep the project moving," says Brock.

Thanks to support from the governor and the mayor, the usual permitting process, which would have taken several weeks, was thrown out. Instead, city inspectors completed their work during the late stages of construction and issued a permit shortly before the building was substantially completed.

The job became a two-shift project — they designed at night and built during the day. Eliminating Issued for Construction design drawings, the design team had several architects and engineers on site daily to produce sketches, answer questions, and issue RFIs in order to keep construction moving. Construction drawings usually were not completed until after the fact; in fact, a complete set of 95 drawings was not available until construction was two-thirds completed.

Shop drawings and submittals were limited as well. For example, no steel shop drawings were produced. Instead, the design engineer was able to see the steel and pipe as it was fabricated on site. Often, acceptance was made and documentation followed so as to avoid delay.

"We knew right away that we had to do everything we could to keep the project on track," said Bill DeLoache, O'Neal senior project manager. "To do that, we just had to keep pushing ourselves forward, even when we hit a brick wall."

For example, the original plan called for using the existing building slab, but it soon became clear that, with the demolition needed to accommodate the footings for an interstitial equipment platform and to house the underground piping, little of the original slab would remain. So the team decided to demolish it. By the next day, a new slab was being readied.

At another turn, the Building Team elected to build a separate 1,100-sq.-ft. structure to house the testing lab and changing facilities, even though a trailer had already been purchased and customized for this use. They decided that this was the best way to meet the FDA's strict requirements. This decision came late in the afternoon of Dec. 20, 2001. Within an hour or so, the team had sketched out a design for the addition on a dry-erase board. By sundown, excavation for the spread footings and at-grade slab had begun.

Similar creative thinking was applied to supplies and equipment. For example, the team determined that there wasn't enough time to purchase the boilers, chillers, cooling towers, and generators needed for the project's plant, so they rented the equipment and installed it in an open area outside the building. (Later, a central plant for the complex would be built.) "We had a very realistic approach," says DeLoache. "If a supplier couldn't make the schedule, we either came up with an alternative solution or found another supplier."

Suppliers were similarly inspired by the project's urgency. For example, Mammoth, a Wisconsin-based maker of air handlers, surprised even themselves by delivering their equipment, capable of 600 air changes an hour, in less than five weeks — something they had never done in less than 12 weeks.

While the construction schedule was paramount in their minds, the Building Team made an effort not to sacrifice the building's style. "This project really required us to be flexible, but also to identify and grab hold of an opportunity when it was there," said Brock. When the masonry supplier told him that the only product that could be ready on time was a buff-colored split-face block, Brock used the buff-colored block and red brick to complement surrounding buildings.

The sense of national mission and their ultimate success made this project one that many Building Team members say will stay in their hearts forever. "This was a once-in-a-lifetime project," says DeLoache. "It's one that brought out the best in everyone, and one I'll never forget."

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