Project SynopsisDevelop a final stage front-end loading engineering package (FEL-3) for the expansion of an active pharma ingredient production facility expansion.
PRODUCTION FACILITY EXPANSION DETAILED PROCESS DESIGN
Process Engineering Associates, LLC (PROCESS) was contacted by the client, a world-wide consumer products and chemicals manufacturer, to execute a detailed process design (FEL-3) to expand the production capacity of multiple cGMP regulated active pharmaceutical ingredient (API) products at an existing batch production facility. The expansion would be accomplished by the replacement of some existing equipment items as well as the installation of new equipment. PROCESS’ role for this design was to develop process engineering deliverables indicating size and capacity requirements for major equipment, as well as the required instruments and controls.
Specific tasks for the detailed process design project included the following:
- Process design basis preparation, which involved developing a design basis document for the proposed process that would govern subsequent process design tasks. The design basis indicated the range of products to be manufactured, as well as guidelines for equipment and piping design.
- Piping and instrumentation diagrams (P&IDs) upgrade, which involved developing issued for review (IFR) level drawings provided by the client into issued for design (IFD) level drawings.
- Finalized equipment sizing and duty specifications preparation, which involved process simulation of the key steps in the production process used for all the client’s intended products. Simulation results were used to select two (2) or three (3) different sizing bases for the key equipment so that a robust design would result. The design dealt with a wide range of chemicals, as well as various types of glass lined equipment.
- Instrument specifications preparation, which involved the preparation of process instrument specifications for the new instruments required for the process.
- Final equipment/instrument/line/tie-In lists preparation, which involved tabulating information from the IFD P&IDs as well as equipment and instrument specifications.
- Emergency pressure relief device sizing and specifications preparation, which involved a review of the P&IDs to help ensure that all necessary pressure safety relief devices are included in the design
Much of the information utilized for this project was previously developed by PROCESS during previous projects.
- Active Pharmaceutical Ingredient Production
- Detailed process design