Case Study

API Product Launch & Building Expansion Project

Challenge:

A leading global Fortune 100 pharmaceutical/biotech company located in the Midwest had a sensitive, ongoing project to redesign and provide the 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 kg in 5 kilo lab suites. Some key redesign challenges included issues with containment, product and personnel safety, construction integration to existing infrastructure, restricted production space, validation feasibility, and maintaining ongoing operations.

Solution:

Valdes quickly mobilized a team of engineers to harmonize with the customers’ project team and understand the current state of the design after it was abandoned by another engineering firm. 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.

Impact:

Valdes assumed responsibility for the project and drove the engineering design to completion. Valdes then supported the project through procurement, field construction, and start-up/commissioning. Valdes stepped up to help a client that found themselves in a difficult situation and followed through to provide them with a successful outcome.