QC Lab

A confidential client possesses an 88,000-square-foot greenfield building designed to accommodate multiple biotech manufacturing buildings and processes on-site. The QC Lab, a three-story facility, contains laboratory and office spaces on each level. The labs are qualified as either Grade D or Grade F and meet Biosafety Level 2 requirements where applicable. The building is supplied with electrical power, plant steam, instrument air, chilled water, and potable water from the site, and it generates clean steam and purified water for internal use. Further, the building has been designed to meet LEED standards in achieving LEED Gold Certification.

Project goals include consolidating the quality control laboratory operations into a singular facility and fostering a unified organizational structure. The project requires start-up, transfer and qualification of all laboratory analyses, and the execution of analytical assessments—all while maintaining the current operations. Once all methods are successfully validated in the new building, the decommissioning of the existing facilities will be carried out as part of a separate project. Gain insight into the services CAI provided that helped the project team meet the target date for achieving the qualification/method verification of the 1st analytical method and remain on track to deliver the project as scheduled.