API Product Launch & Building Expansion Project
A leading Global Fortune-100 Pharmaceutical / Biotech company located in the Midwest U.S. engaged the services of Valdes for a time sensitive ongoing project to redesign and provide project construction assistance, startup and commissioning services necessary to increase the production of a human therapeutic highly potent (Safebridge Category 3) active pharmaceutical ingredient (API) with capacities of up to 10 Kgs in 5 kilo lab suites.
The project overview involved a 12,000 square foot expansion of an existing building, retrofit of existing production spaces to ISO 14644 Class 8 cleanroom and Class 1 Division 1 electrical classifications, new equipment installation (filter dryer, tanks, vacuum system and pumps), rework of the existing production train process and utility piping and controls and automation upgrades. Key redesign considerations addressed issues with containment, product and personnel safety, construction integration to existing infrastructure restricted production space, validation feasibility, and maintaining ongoing operations.
Valdes mobilized a team of engineers to harmonize with the customers’ project team and understand the current state of the design. Valdes assumed responsibility for the project and drove the engineering design to completion. Valdes then followed through and supported the project through procurement, field construction, and start-up / commissioning.