Case Study: API Recovery Process
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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.
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Case Study: API Recovery Process
- 1. Consultancy. Project Delivery. Innovation. Case Study: API Recovery Process Process Design leads to £10m/year savings Client: Multinational Pharmaceutical Manufacturer
- 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 Page 2
- 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 Page 3
- 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 Page 4
- 5. Final Process Flow Diagram Page 5 +5°C HTF Vent Condenser E6-3010 VOC Abatement FIQ Pure Water +5°C HTF Vent Condenser E6-0984 VOC Abatement GN2 FIQ Pure Water E6-0700 Feed Vessel 10m3 1500, 1600 & 2000 Mother Liquors Salt Soln to Heel Recovery Retreat Material or NaCL E6-3003 GN2 GN2 GN2 GN2 PRODUCT +5°C HTF Condenser 1M HCl YI 3rd Floor 1st Floor Ground Floor 2rd Floor E6-0500E6-0800 E6-0600 E6-0400 YI Dedicated Filter Dryer Calcium Chloride (Ex-E6-1829) MTBE Solvent (ex Bulk) +5°C HTF +5°C HTF Vent Condenser Vent Condenser FIQ 1M HCl 0.25M NaOH Decant Decant pH pH +5°C HTFDistillation Condenser E6-3003 (Spent MTBE) 4m3 E6-3003 (Waste Distillate) FIQ Pure Water 10m3 10m310m3 6.3m3 E6-1320 E6-1300 SOLID PRODUCT to Matcon Bins Precipitator E6-3101 Waste Tank (Grand Mother Liquors) Dedicated Filtrate Receiver Aqueous Receiver Extract Receiver Extraction Vessel Vacuum Distillation 10m3 VOC Abatement +5°C HTF -20°C HTF Condenser Condenser E6-3003 E6-3005 3005 E6-3003/5 E6-0200 E6-3005 E6-0207 E6-0204 E6-0201 E6-0507 0.25M NaOH Pures Charging Booth E6-0420 E6-0520 E6-0505 Organic Aqueous Waste E6-3001 E6-0208 4"SelfVent-Lined 6"SelfVent-Lined 3"SelfVent-Lined E6-0613 E6-0511 Venting Manifold E6 – 0825 (coarse filtration) SP E6-0205 SP HCC Pump E6-0203 Vent E6-0206 +5°C HTF Vent E6-0605 E6-0405 E6 – 3505 (fine filtration) E6-0211 Vac Pump E6-0980 VOC Abatement +5°C HTF Vent Condenser VOC Abatement E6-0512 VOC Abatement E6-1200 Precipitator Filters 1520, 1620, 2020 Glove Bag E6-0982 (Ex E6-0613) Backventing Line E6-3003 GN2 SI-01 SI-02 SI-03 FCV Waste Receiver INVENTORY 11 INVENTORY 08 INVENTORY 09 INVENTORY 10 INVENTORY 07 INVENTORY 02 INVENTORY 01 INVENTORY 04 INVENTORY03 INVENTORY05 INVENTORY06 Including all Services/ Utilities & Relief Streams INVENTORY 12 INVENTORY 13 MTBE Storage F120 & Transfer Line to E6 E6-0713 E6-0413 1st Floor Ground Floor 2rd Floor E6-0202 (Ex E6-0511) Part of Inventory 12 Inside E6
- 6. Cycle Time Evaluation – Software Tools Page 6 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 Page 7
- 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 Page 8
- 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 Page 9
- 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 Page 10
- 11. Summary Page 11 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