Bulk Complex Formulation System
Duration- 16 Months
Overview- Mangan provided Commissioning & Qualification project management services for a Bulk Complex Formulation System composed of the following equipment:
- Formulation Tanks
- Spray Dry System and Filter Bank
- Vacuum Reduction System
- Hydration Skid – Including Hydration Tanks and Homogenizers
- Clarification Tanks
- Sterile Filtration System – Including Sterile Filtration Tanks
Strategy- Successfully install, commission, and provide qualification support for a bulk complex system by maintaining direct and consistent communication with trades, quality, engineering, and validation resources.
Process- The Mangan project manager was responsible for developing an overall Commissioning strategy, coordination of resources and activities for trades, weekly status updates and daily debriefs. Other responsibilities/activities included:
- Control and Management of Lifecycle Documents (i.e. URS, FRS/FDS, HDS, SDS, SOPs, etc.)
- Support the Asset Induction Process
- Generate and Route Assessments and Conduct Risk Assessments
- Review Factory Acceptance Testing and Site Acceptance Testing and work with vendors to complete SAT.
- Start-Up Support
- Provide Device/Loop Checks, sequence of Operation Tests, and source code verification
- Generate Commissioning Plan and Route for Approval
- Execute Commissioning Plan
- Generate Commissioning Final Report and Route for Approval
- Field verify P&IDs and schematics drawings from OEM’S
- Draft Operational SOP’s
- Draft PM Procedures
- Qualification Support
Result- The project was completed within the scheduled timeline in preparation for process development and demonstration batch manufacturing.