The consultancy led the front-end engineering design and detailed design of a new process for a pharmaceutical manufacturer to recover a valuable active pharmaceutical ingredient (API) from aqueous mother liquors. Through advanced process simulation and design, they developed a process that achieved 90% recovery of the API and saved the client around £10 million per year. Their work included evaluating three potential locations on site, optimizing the cycle time through simulation, and fully designing the new process while reusing existing equipment to minimize capital costs. Commissioning validated the predicted cycle time and recovery levels, and the client reported trouble-free operation since with the new design meeting their budget and timeline.
2. Who are we?
Process engineering consultancy
Specialising in advanced modelling techniques, to give answers that
are more accurate, reliable and robust
Decades of process and mechanical engineering experience
Combine cutting edge simulation with real world understanding, to
provide you with solutions that are effective and practical.
Experience in Pharmaceutical / Fine Chemicals
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3. Project Background
FDA Approved Process
Manufacture of valuable API, recovered through filter dryer
10% of product lost as 0.7% solution in aqueous mother liquor,
representing ~£15m/year
Lab scale trials had demonstrated 90% recovery of this when extracted
with acidified MTBE in a stirred batch vessel
Caustic added to MTBE solution, API forms the soluble sodium salt in
the aqueous phase in concentrated form.
MTBE removed by batch vacuum distillation
Calcium added to aqueous phase to precipitate out the API
API re-filtered and spent mother liquor sent for further effluent treatment
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4. Our Responsibilities
Work within constraints fixed by pilot trials and FDA application and
three possible locations on site
Complete survey and feasibility to determine best location, that:
Minimises cycle time, does not restrict main production of API
Minimises capital cost
Can be sufficiently automated
Will not result in more solvent emissions from the site
Write up feasibility work and produce flow diagram of proposed option
Develop Front End Design
Develop Detailed Design
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6. Cycle Time Evaluation – Software Tools
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Using Aspentech’s Batch Plus Simulation Software to:
Develop process recipe and run as a script
Quickly identifies pinch points and conflicts
Optimise process step timings and use as basis for sizing equipment
Obtain outline heat and mass balance and utility consumptions
Support the design from concept to commissioning
Develop first draft Standard Operating Procedures
Develop OQ Protocols
7. Process Design Activities – Part 1
Process changes on P&IDs
HAZOP
Checking suitability of existing equipment (e.g. pumps, lines)
New line sizing (pumped and gravity) for new plant configuration
New equipment specifications (e.g. vessel, agitator, heat exchangers)
Full materials of construction review, particularly as strong acids used
Consideration of MTBE vapours when moving liquids between vessels,
quantifying simultaneous vapour losses to assess impact on CATOX.
Specification of high efficiency knock-back vent condensers
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8. Process Design Activities – Part 2
Full utility assessment, particularly on chiller system, to understand
instantaneous demands and impact on other building users.
Balancing heat transfer fluid systems to route to new locations.
Assessment using network flow software such as AFT Arrow/Fathom
Two phase reacting relief studies for vessels and jackets
Development of IQ/OQ protocols and briefing of production staff on new
process design
Overseeing mechanical design to ensure that process requirements are
met
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9. Outcomes
Predicted cycle time and product recovery proved on commissioning
Design made the best use of existing equipment and maximised gravity
transfers to avoid purchase of additional pumps
Project budget and timescales met
Minimal required changes at commissioning
Client reported years of trouble free operation since commissioning
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10. Summary
Led FEED and oversaw Detailed Design to deliver process providing
client with ~£10m/ year savings
Used a combination of simulation expertise and design experience to
minimise capital costs (including re-use of existing equipment) and
optimise operations
Fully evaluated all the production risks with sharing the facility, including
ease of construction, risk of cross contamination and automating needs
Provided a full design package with supporting process calculations and
documentation, including two-phase reacting relief
Process was implemented with minimal start-up changes, and predicted
cycle time was validated
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11. Summary
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Consultancy.
Project Delivery.
Innovation.
Please get in touch to find out how we can help your
business today.
E: enquiries@flexprocess.co.uk W: flexprocess.co.uk
T: +44 1454 629 689