The Hillsboro operation for this California based biotechnology company currently runs two production lines, where it packages bulk drugs into individual doses and vials for distribution.
he facility was needing to expand to allow for a third filling line within the company’s existing 340,000 square foot facility.
Harris Group provided mechanical, electrical, and plumbing (MEP) systems to meet stringent client, FDA and European regulatory standards as they apply to current good manufacturing (cGMP) processes, clean utilities and facilities.
Several phases of the design needed to be coordinated with key shutdown periods that are required for support and component preparation areas along with the new filling suite.
Over 70 subject matter experts and engineers supported this work primarily from Harris Group’s Portland, Oregon office with addition support from Seattle, San Francisco, Denver and Charleston. The designs provided to the client were successfully implemented into the construction phase.
Modifications to component preparation was implemented in parallel as part of the overall project. Equipment modifications included demolition in component prep area to include removal of existing heat exchanger, ultrasonic sink, parts washer, and some wall partitions. Harris Group relocated a stopper loader unit and upgraded component prep layout/wall configurations. We converted existing shell space to create a new formulation suite where we installed two new 2000L formulation tanks and WFI heat exchangers with associated piping and utility systems.
Multidiscipline design implementation into successful construction design.
Modifications to component prep areas included the installation of 2 new pass through parts washers, three new filter integrity stations, a new HVAC unit, and new autoclave and stopper processing systems with associated processing vessels.
Plant utilities modifications included piping for refrigerated water distribution to provide sufficient capacity to users. We increased the size of refrigeration glycol pumps with associated piping changes to provide sufficient capacity to users.
Harris Group replaced the existing Lyo area PWW lift station pumps and piping, installed a new PWW equalization tank in the waste water treatment area and increased PWW heat exchanger capacity.