Develop a preliminary pilot-plant process design package for the production of a coated/encapsulated active pharmaceutical ingredient based on lab scale process development results.
PRELIMINARY PROCESS DESIGN OF AN ACTIVE PHARMACEUTICAL INGREDIENT PILOT-SCALE PROCESS
The ultimate client, a large international pharmaceuticals company, has developed and currently operates a lab-scale process for the production of coated/encapsulated active pharmaceutical ingredients (APIs) at their U.S. research facility. The ultimate client engaged the client, a detail engineering firm, to design and build a facility for a pilot scale production process. The client contracted with Process Engineering Associates, LLC (PROCESS) to prepare the process design information that would enable them to execute the detailed engineering phase of this project.
PROCESS project tasks included:
- Develop a comprehensive detailed mass and energy balance for the new pilot scale process that involved heptane, dichloromethane, ethanol, methanol, benzyl alcohol, PLGA, PVA, and ethyl acetate. This consisted of major, minor, and utilities streams flow rates, compositions, temperatures, pressures, and physical/chemical properties. This also involved the set-up of the process simulation models in CHEMCAD software.
- Prepared preliminary equipment specifications for the new major process equipment items. Equipment specifications were provided for seven (7) tanks/agitators, five (5) temperature control units, nine (9) pumps, and other related equipment.
- Provide P&IDs for a flexible, reconfigurable process system.
- Identify vendors and equipment models for the various unit operations required in the process.
- Complete a process description for the system operation for the three primary chemistries.
- Complete a controls description for the process units that would allow a high level of flexibility with local controls.
The process design deliverables will allow the client to install the required power and facility streams for the pilot unit. The ultimate client obtained quotes for the needed pilot-scale equipment.
- Pharmaceuticals Manufacturing
- Process scale up engineering