BUILDING P VIRUS MODERNIZATION
The purpose of this project is to renovate approximately 4100 square feet of existing virus manufacturing and laboratory space constructed in the early 1980s to meet current USDA good manufacturing practices, including ISO-level clean room and containment designs. Designed upgrades and modification include the following:
- Reconfiguration of manufacturing spaces to achieve multiple imperatives, including: separate clean cell manufacturing activities from virus manufacturing activities; improve flow of personnel, including one way flow in virus manufacturing suite; provide separate airlocks for personnel entry, equipment entry, and exit; separate cleaning and sterilization activities from routine manufacturing activities to improve risk profile.
- Design of two separate clean room air handling systems, including class C space for clean cell propagation and Class A / B / C space for virus manufacturing in roller bottles, stainless steel bioreactors, and single use bioreactors.
- Design of walk-in incubators designed to control temperatures from 25 – 40 *C.
- Process utility design for clean-in-place generation and distribution; USP purified water generation, storage, and distribution; USP pure steam generation and distribution; relocation and expansion for existing USP Water for Injection (WFI) generation, storage, and distribution; process gas generation and distribution, including clean compressed air, nitrogen, carbon dioxide, and oxygen; process waste collection, inactivation, and pH adjustment.
- Process and HVAC automation system design, including cascading room pressurization control.
Design and construction is phased to allow continuous, but reduced, operation of existing manufacturing activities, in order to minimize production shutdowns. Design and construction is complicated by extremely tight floor to structure dimensions, requiring very tight coordination between all disciplines. Design was also coordinated with the owner’s key personnel for testing and balancing, as well as facilities maintenance personnel to assure that the facility meets their requirements for ongoing maintenance and service work.