Life Sciences

Technical Leadership from Planning to Commissioning

Valdes Engineering Company’s full range of engineering and architectural services supports clients in the pharmaceutical, biotechnology and consumer products industries. Our clients engage in self-manufacturing, contract manufacturing, and contract research and development. The Valdes team’s expertise encompasses all phases from initial planning and conceptual development, through detail engineering, procurement, construction management, and commissioning and validation of processing units.

Life Sciences Project Experience

• General cGMP Requirements

• API/HPAPI/ADC Unit Operations and Facilities

• Aseptic Processing

• Clean Utilities

• QC and R&D Facilities

• API Small and Large Molecule Unit Operations and Facilities

• Commissioning and Validation

Case Study

Chemical 2 Facility Upgrade

Chemical 2 Facility Upgrade

A pharmaceutical contract manufacturing organization (CMO) needed to increase its active pharmaceutical ingredient (API) production capacity. However, the client needed to determine the most cost-effective approach and was considering transforming an existing batch fine chemical facility constructed in the 1960s into a bulk API facility.

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API Pilot Plant Flow Chemistry Suite

API Pilot Plant Flow Chemistry Suite

A leading global pharmaceutical/biotech company and a Fortune 100 top employer needed to convert a clinical supplies/R&D pilot plant to an HPAPI/ADC flow chemistry facility so that they could continue to provide the lifesaving medicines that their patients need. The demolition of various existing equipment and the installation of new equipment was confined to a limited space.

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API Product Launch & Building Expansion Project

API Product Launch & Building Expansion Project

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.

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Full Service Project Delivery Process

Life Sciences

FRONT-END ENGINEERING & DESIGN

Business Planning

Project Development

Project Economic Analysis

DETAIL ENGINEERING

Project Execution

Turnaround

PROJECT TURNOVER

Start-Up

Commissioning

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