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.

Services

Mechanical

Process

Instrumentation & Controls

Piping & Plant Layout

Procurement Services

Construction Management

Validation