TCS has assisted our clients in the procurement of a wide range of custom equipment. Our experience managing these specialized vendors helps drive a successful project that finishes on time and within budget. We draft User Requirement Specifications, develop Request for Proposals (RFPs) and assist client Sourcing Managers with bid levelization and vendor selection. Once an order is released, TCS oversees design, delivery and installation and CVQ activities. TCS has served as the lead technical Owner’s Representative for national and global clients during equipment factory acceptance tests.
Production Equipment
Refurbished and Upgraded Liquid Nitrogen Lyophilizer
TCS provided Engineering Project Management support to our Client 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.
Single Use Technologies: SUBs, SUFs and SUMs
TCS has managed several projects involving the sourcing, installation and qualification of single use bioreactors, fermentors and mixers. We are experienced with multiple control system platforms having both cGMP and non-cGMP packages on vessels ranging from 30L to 2000L. Our services have included drafting the user requirement specification, design and shop drawing review, witnessing both factory and site acceptance testing, and supporting post SAT qualification activities.
Research & Development
Parasitology Robotic Screening Station
TCS served as the Engineering Project Manger for the sourcing, design and installation of a new robotic screening station for our client’s Parasitology group. The automated platform was designed to integrate and operate a dozen individual pieces of lab equipment. A full enclosure with HEPA exhaust was installed around the platform. TCS served as the lead client representative on the design team and managed the budget and installation of the equipment.
Glass Vile Filling and Capping Machine
This project consisted of the purchase and installation of an automatic filling, plugging and capping machine to complete the client’s formulation and filling needs. TCS oversaw the design review and traveled to Bausch + Strobel’s Isholfen, Germany manufacturing facility to witness the factory acceptance testing on behalf of the client. TCS also witnessed the site acceptance testing and managed the installation, start-up, training and IQ/OQ activities. Installation of MEP facility modifications and upgrades necessary for the operation of the equipment were included.
Additional Miscellaneous R&D Equipment
TCS has managed several other projects involving the sourcing, installation and qualification of R&D equipment including a Sartorius AMBR250 high-throughput bioreactor system, a Sartorius kSEP single use centrifuge and a GE AKTA Process chromatography skid. For each of these projects, TCS served as the Project Manager to manage the overall purchase and installation of the equipment, facility upgrades, and support commissioning and qualification activities.