Control System Upgrade for Production Lyophilizers
Duration- 6 months
Upgrade the existing control system for production lyophilizers at a large biotech company.
Scope of Work:
The project scope included:
- PLC and HMI Upgrade for Multiple Lyophilizers
- ControlLogix and iFIX
- Design Documents (DDS, SRS, FRS)
- Functional Testing
- Protocol Development and Execution
- FTBatch HMI/SCADA
The Mangan team collaborated with the onsite automation staff and business users to perform design reviews to optimize HMI displays and screen navigation.
Project was completed successfully on time.
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.