Acambis, Inc.
Vaccine Manufacturing Facility
Massachusetts
Paulus, Sokolowski and Sartor (PS&S) provided architectural*, engineering and validation services for the renovation of a 30,000 sf biotech manufacturing facility. Major upgrades were made to process utility and building systems to bring the building up to current Good Manufacturing Practice (cGMP) operational status. Approximately 5,000 sf of shell space was fitted for manufacturing operations.
PS&S extended the existing Water-for-Injection (WFI) distribution loop to the new sterile production suites and provided WFI drops and utility panels in each suite.
Separate air handlers were provided for each manufacturing suite to ensure isolation between manufacturing operations. A 5,000 sf mezzanine was created and fitted out to provide offices and workstations, as well as a microbiology Quality Control (QC) lab. The project was designed and executed on a fast-track basis.
PS&S was responsible for the qualification of manufacturing process equipment and the supporting utility systems for the development of both viral- and bacterial-based vaccines. Laboratory facilities, including analytical and stability equipment used to test and release vaccines, were also qualified as part of the project. Validation of critical systems included the development, execution, and preparation of reports for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
*Architectural services are provided by Paulus, Sokolowski and Sartor Engineering, P.C., Paulus, Sokolowski and Sartor Architecture, P.C., PS&S California, Inc., or Paulus, Sokolowski & Sartor Architecture and Engineering Connecticut, P.C.