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The University of Chicago Kovler cGMP Laboratory: Converting Basement Space to BSL-3 and Class 10,000

Michael Yoshimura, AIA, OWP/P Chicago

This $2.1 million Kovler Hall upgrade provides The University of Chicago Biological Sciences Division (BSD) with a high-purity clinical Good Manufacturing Practices (cGMP) facility that will support the development and clinical trialing of new groundbreaking technologies in the areas of stem cell pancreatic islets, dendritic, hepatic, and bone marrow applications. The facility is a Biological Safety Level-3 (BSL-3), Class-10,000 stem cell production lab that provides the stringent clean room environment to limit particle interference so the outcome of the cell and gene therapy work is not affected by impurities.

This project required the design team to convert an underutilized basement space below existing labs within a two-story building into a cGMP biological pilot plant providing the stringent clean room environment required for cell and gene therapy work. Technical performance, process and cost controls, timeliness, and a high level of service resulted in two high-purity cGMP lab suites.

With a collaborative team approach, this challenging project met the rigorous FDA standards for clean room construction. Our procedures proved so effective that the testing and certification process determined that, in addition to easily meeting all the targeted Class-10,000 requirements, the lab met two of the three parameters for a Class-1,000 space.

Phil Lasarsky of Steve Rosenstein & Associates, the lab planner who collaborated with us on this project has said:

"With an intense schedule and a level of complexity not usually encountered, the quality of construction was beyond our expectations. We believe the facility will become the benchmark the industry will want to emulate."

Findings:

Indoor air quality was an important consideration on this project to support the occupants' work in a cGMP Class-10,000, BSL-3 environment. The lab spaces were designed at air change rates higher than required by the City of Chicago Building Department and the Illinois Department of Public Health, and were designed to comply with the current ASHRAE 62 indoor air quality standard, and the current ASHRAE 55 thermal comfort standard. The design air change rates also meet the current needs and anticipate the future needs of the lab suites.

One of the key challenges to the project was to minimize disruptions to the existing Kovler Building's occupants and systems, specifically the lab space located directly above our proposed lab suites. Compounding this issue was the need to design a cleanroom ceiling without any access doors and a low floor to floor height of 12"-0". These space constraints required locating the new exhaust air dampers and air valves in congested existing mechanical spaces; the creative use of existing chases for the new supply air and BSC exhaust air ductwork; the creation of two new chases for the general lab exhaust air ductwork and the creation of a new mechanical penthouse to locate the new supply air dampers, hot water reheat coils and air valves.

As a result, we were able to work around the existing lab space on the floor above, except for the creation of two chases in the men's and women's locker rooms. We were successful in maintaining the operation of the existing lab with only minor inconveniences to the occupants outside of the lab.

Labs21 Connection:

The construction process was especially demanding because of the extreme standards of cleanliness required to obtain certification of the finished facility, and because of the stringent documentation procedures established for each phase of the work. Every tradesman received advance training and instruction on the strict guidelines required for working within the area. Each separate piece of ductwork was fabricated, numbered, cleaned and sealed offsite, then cleaned again before being brought into the space, unsealed at one end, installed, and written off the check list.

Addition of more sophisticated controls and monitoring/measuring equipment allows the system to react to the actual demand conditions and to be more energy efficient; allows for daily system adjustments; allows preventive maintenance to occur; reduces costly repairs; and prolongs the life of the equipment. The new head end control system for the cGMP Lab was interfaced with the existing campus building automation system to eliminate the need for a 24/7 on-site building engineer.

The scope of this project did not provide us with an opportunity to make an environmental impact in terms of reducing CO2 and CFC emissions. However, our design did have an environmental impact in terms of the specified zone pressurization controls and fume hoods ensuring contamination control and greater occupant safety. (By definition, BSL-3 labs are areas where work is done with indigenous or exotic agents that can cause lethal or serious disease through inhalation.) As noted, 100% outside air was used to maximize dilution of harmful airborne contaminants. The specified exhaust fans have a very high effective stack height to avoid re-entrainment of air into the building.

Biography:

Michael S. Yoshimura, AIA-In more than 20 years of working with The University of Chicago, one of the premier research institutions in the nation, Mike has developed extensive laboratory credentials. In 1997 and 2002, he added to his existing credentials with studies in laboratory design at Harvard University's School of Public Health and Graduate School of Design. Mike's experience in developing laboratory environments is second-to-none and is displayed in his work with University of Chicago Hospitals, Northwestern Memorial Hospital and the University of Illinois at Chicago. A principal of OWP/P, he is a licensed professional architect and a member of the American Institute of Architects and the Society for College and University Planners.

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