Client: BAYER - Clayton, NC

Project: Automated Plasma Bottle Opening System

Estimated Construction Cost: $ 8 MM

Overall Project Management and Lead Design Firm for Preliminary Design through Construction Administration 

Scope: Convert abandoned building space into Class D clean room spaces for new automated bottle opening machine to process incoming plasma raw materials.

• Process, Material, and Personnel Flow Diagram Development
• Integration of Owner-purchased Automated Bottle Opening Machine imported from Spain
• Design of new Plasma Pooling Vessels, including Process Delivery systems
• New utilities, including HVAC, Vessel Heat Transfer Skid, CIP Skid, and HWFI/CWFI
• Waste Bottle Recovery System

Client:  CARDINAL HEALTH - Raleigh, NC  

Project: Aseptic Flex Space/Aseptic Filling Suites

Scope: Upfit pre-existing cGMP space for flexible aseptic manufacturing suite. Upfit adjacent suite for Class “A” and “B” clean room filling operations and rerouting existing degown and airlock areas.

• Equipment and Waste Handling Air Locks
• Plenum-type, HEPA Ceiling System
• Stainless steel Return Chases
• Designed per cGMP, FDA, and EMEA guidelines for Aseptic Production spaces
• Air Lock Controls
• Differential Pressure Controls
• Particle Monitoring System

Client:  GLAXOSMITHKLINE - Zebulon, NC  

Project: Packaging Line Additions

Estimated Construction Cost: $25 MM

Project fast-tracked due to global urgency to increase distribution of multiple dosage inhalant to counter Asian avian flu.

Designed for construction in active process areas.

Scope: Reconfigure area adjacent to existing Fill/Packaging operations for two new packaging lines with fill, final package, and staging areas. Modify existing blending suite to support new product.

• Separate HVAC systems to meet Product Isolation Requirements
• Modular Clean Rooms placed in Fill Areas
• Integration of New Packaging Equipment with Existing
• Differential Pressure Monitoring

Client::  STIEFEL LABORATORIES - Research Triangle Park, NC 

Project: Clinical Trial Suites

Scope: Upfit of existing facility to include a new cGMP clinical trial suites. Once constructed, the suites would be used to improve process optimization and to ramp up process development to supply clinical quantities. The lab would be capable of supplying cGMP clinical semi-solids on a worldwide basis. Supporting systems and work spaces, including warehousing, weighing/dispensing, sampling, gowning, and utilities, were part of the design. Systems were designed for flammable solvent-based processes.

• Converted European-supplied equipment for US use
• Designed spaces and equipment for Class 1 Group D Division 1 compliance
• Process cooling water system converted to closed loop
• Designed space for flexible operations
• Aerosol/foam process suites