Case Study
API Pilot Plant Flow Chemistry Suite
Challenge:
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.
Solution:
Valdes was able to accommodate the many moving pieces of this project in a confined space and deliver a thorough plan for the demolition, rearrangement and installation of pressure vessels and agitators, chromatography column and pumps, process instrumentation, power wiring/conduit, vacuum, buffer prep transfer lines, and associated utilities, including nitrogen, compressed air, propylene glycol supply/return, fresh water and hot water (lab), water for injection (WFI), and breathing air. Architectural support and HVAC activities were also provided to accommodate modifications and the new room layout.
Impact:
Valdes performed the front-end engineering design and the detail engineering to scale up the existing infrastructure for greater production of active pharmaceutical ingredients (APIs) and antibody-drug conjugates (ADCs) via flow chemistry from the original batch-production technology.
SERVICES:
Mechanical
- Facility Design & Plant Layout
- Equipment Selection
- Material Handling & Dust Control Systems
- Rotating Equipment Sizing & Specification
- HVAC
- Fire Protection & Detection
- Plumbing
- Fluid Heat Tracing
- Blending & Mixing Systems
- Heat Exchanger Selection
- Plant Utilities
- Industrial/Hygiene Ventilation
- Equipment & Piping Specifications
- Field Walkdowns/Constructability Review
- Pressure Vessel Design
Electrical
- System Analysis (SKM Power* Tools):
- Load Flow
- Short Circuit
- Overcurrent Coordination
- Arc Flash
- Transient Stability
- Utility/Industrial & Transmission/Service Substations
- Industrial Power Distribution:
- Power Transformers
- Low/Medium Voltage Switchgear
- Motor Control Centers
- VFD Installations
- Protective Relay Settings, Generators & Distribution
- Diesel Generator and UPS Systems
- DC systems
- Grounding & Lightning Protection
- Lighting
- Equipment & Raceway Layout Drawings
- Wiring Diagrams & Schematics
- Electrical Heat Tracing
- Area Classification & Code Compliance
Process
- Simulation & Modeling
- Studies
- Technology Evaluation & Selection
- Front-End Project Development
- Process Optimization
- PFD/P&ID Development
- Heat & Mass Balance
- Equipment Selection & Specification
- Process Equipment Evaluations
- Relief Device & System Analysis
- Utility System Design & Evaluation
- Process Control Design
- Process Scope Development
- Effluent Handling System Design
Architecture
- General
- Existing Conditions Assessment
- Master Planning
- Programming
- Code Search & Analysis
- New Building Design
- Building Renovation and Addition Design
- Construction Documents
- Bridging Documents
- Bidding Support
- Construction Administration
- Sustainability (i.e., LEED, Green Globes)
- Permit Support
- Life Sciences
- Science & Technology Facility Design
- Functionality (Flow of People and Materials)
- Space (Environment & Human Impacts)
- Regulatory (FDA, GMP, HSE)
- Commissioning / Qualification Support
- Laboratory Planning and Design
- Industrial
- High Hazard Facility Code Analysis
- High Hazard Facility Design
- Design for Client Specific equipment / processes
Project Management
- Fast Track Project Execution
- Formal Project Communication Methods
- Strategy Development
- Financial Management
- Critical Path Schedules
- Project Risk Assessment & Risk Mitigation
- Cost Tracking & Reporting
- Cost Estimating
- Feasibility Analyses to Guide Strategic Business Decisions
- Commissioning/Start-Up Planning
