TCS has managed numerous projects for our clients in both the human and animal health fields. Our diverse project portfolio in this arena includes both new facility construction as well as renovations and expansions to existing facilities. When working in an existing facility, it is critical to minimize production interuptions and communicate clearly with the stakeholders. Our experience allows us to anticipate and minimize potential impacts to operations which leads to a better project outcome. Select projects from our portfolio are listed below.
Filling and Freeze Drying Production Facility
TCS served as the lead Owner’s Representative / Engineering Project Manager for the design, implementation and qualification of a ~47,000 sqft GMP facility including CLA sterile aseptic blending, 600vpm filling, automated freeze drying, refrigerated storage, ancillary support areas and area for a future sister line. This brownfield site was completed in under 24 months from initial construction through facility qualifications and start of production, all occuring without interuption to the Owner’s adjacent operating and production facilities. This project was successfully and safely implemented for the Owner with zero lost time injuries across more than 650 contractors and >160,000 craft and site team hours.
Single Use Bioreactor Train Production Suite
TCS served as the lead Project Manager for the design and of a production suite renovation. The existing suite will enable the production of three new products by modifying the existing suite to include (2) Single Use Bioreactors (SUBs) and one new concentrator. Transfer piping and control modifications will be made to four (4) existing 2400L stainless steel bioreactors and a centrifugal separator to incorporate into the new bioreactor trains. TCS is responsible for the facility modifications as well as managing the purchase, design, installation and qualification of the new process equipment.
Production Facility Decommissioning and Process Equipment Relocation
TCS served as the lead Owner’s Representative and Engineering Project Manager to coordinate, decommission and mothball a 40,000+ sqft Biopharmaceutical Production Facility. Existing production operations were transfered to another sector within the business network. TCS addressed specific risks created by the consolidation of production entities and developed and maintained the project schedule for operations, quality and business continuity. Our team also governed contractual relationships in the transfer of valuable production equipment and processes.
LN2 Freeze Dryer Upgrades & Relocation
TCS was the Engineering Project Manager for this fast-tracked design/refurbishment-upgrade/implementation project. The decommissioned freeze dryer was disassembled, transported to it’s OEM manufacturer for refurbishment, including up-fitting with Steam-In-Place (SIP) capabilities and -50C tray loading capability, for transport and installation into +1K Sq. Ft. renovated facility. The project delivery method shortened the Client’s schedule by +3-months, supporting their aggressive approach for improvement in site supply reliability. The project included a class-A production suite, supported by N+1 MEP equipment, including a custom fan-wall AHU, HEPA exhaust system, HEPA re-circulation modules, supporting process equipment and piping. TCS managed the project from design through PQ activities, including Factory Witness Testing for contractual compliance and schedule adherence.
QC Laboratory Expansion
TCS served as the lead project manager for the design and construction of Immunochemistry and Virology labs for our client’s Quality Control department. This design-build project was fast tracked in order to accommodate an influx of new production at our client’s facility.
Master Seed Freezer Suite
TCS was the lead Engineering Project Manager for another fast-tracked design-build project. This project included the renovation of existing underutilized space within the client’s production facility into a new master seed storage area. The new suite was configured to house a mix of LN2 and -80°C freezers. The suite also included a control rate freezer and portable LN2 dewer fill station. The existing AHU was replaced and upsized to handle the increased heat load. A redundant fan coil unit, emergency generator and BAS monitoring were added for added protection against lost contents.