Case story
Establishment of New Final Handling
To expand the capacity of Syntese A/S’ API handling a new facility was established containing the three final steps in the production of Mesalazin bulk. The facility includes a centrifuge, a vacuum dryer and powder management, including supply plants (GMP and non-GMP). In addition, the facility is prepared for installation of an extra process line for API handling as well as two pieces of trap tanks.
The process
Syntese managed the overall project management with regard to the establishment of the building, procurement of a centrifuge, a vacuum dryer, ventilation, utility water installations, heating and electric and SRO installations.
Process Engineering reported to the project manager from Syntese and provided consulting services on supply plants (GMP and non-GMP) and powder management.
The supply plants included steam, condensate, refrigeration, vacuum, water, waste water, alcohol, process water, air pressure and nitrogen. To streamline the process we focused on using commissioning tests as raw data during the qualification. All of this took place in partnership with Syntese.
Service and scope of the project
- P&I Diagram
- Item lists
- Tender material and requirements specification
- Installation tender
- Installation and construction management
- Start-up management
- Start-up engineer(s)
- SAT and supervision
- Documentation
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