Vial and PFS Filling Expansion
- 200,000 SQ. FT.
- Isolator Vial Filling
- Isolator PFS Filling
- Vial Inspection
- PFS Inspection
- Master Planning
- Process Modeling & Scale-up
- Project Execution Plan
- Project Schedule
- Resource Planning Cost Estimate
- Mechanical, Electrical, Process + Process Control Design
- System Controls
- Project Management
RGD, Integrated Design Architects, Stewart, Inc.
Our client intended to increase and expand the capacity of its product filling operations at their production facility located in Clayton, North Carolina. As part of this effort, the HIPP lead engineering team supported the development of User Requirements Specifications (URS) for major process equipment and provided a design to modify the legacy facility for an expansion of formulation, filling, and finish operations. The modifications included new formulation suites, new isolator vial filling lines, and replacement of existing vial filling lines with isolator filling lines. HIPP’s design included an expansion of the Pre-Filled Syringe (PFS) filling operation with new isolator PFS lines and an inspection system with formulation area optimizations as well.
To support the production scale-up spaces for additional personal, work in progress (WIP), sterilization, raw material warehousing, staging, and utility infrastructure was expanded. To support the additional personnel a new interconnected two-story production/office/mechanical room/dining area expansion was designed along with the renovation of existing production and laboratory space.
The client’s N+1 redundancy requirement is met in a cost and space-efficient manner. This included increasing generation and distribution of clean piped utility capacities, CIP, process waste, HVAC, power, black utilities, and control systems.
The control systems included manufacturing execution system (MES), OEE tracking system, particle monitoring, material tracking, SCADA, and Batch systems. Upgrades to the emergency power infrastructure included Flywheel UPS power as well as a new generator.