919-827-0933 info@manganbio.com

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.

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