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Primary Continuous Processing Retrofit
- 2. PRESENTATION OUTLINE • Scott Process Design Development • Steve Facility Design Development • Shamai Project Management Closing
- 3. PROJECT BACKGROUND • Process development trends – exploring flow chemistry by first intent • Benefits of continuous processing • Bridge to commercial facilities • Existing/limited facilities footprint – for batch equipment • Single known user requirement: Agile flexibility! • Designing to a vision Project Drivers in Pilot Plant Environment Known Challenges
- 4. PROCESS DESIGN DEVELOPMENT • Smaller facilities footprint for equal capacity • Lower energy requirements for heat transfer • Lower solvent requirements • Improved control of energetic reactions • EHS improvements – smaller quantities at any given time All understood – just no Pilot Plant capability Expected Benefits – The Basics
- 7. PROCESS DESIGN DEVELOPMENT • Flow chemistry equipment is available • Examples of lab set‐ups are common • Examples of large commercial set‐ups are common • Pilot Plant Space not well defined….at least for this project • Agile Flexibility Early Lessons Learned
- 8. PROCESS DESIGN DEVELOPMENT • Delivery of raw materials, collection of product and waste solutions • Utility needs • Typical safety needs • Typical footprint of equipment – is a typical space acceptable for all equipment (modular?) • Flexible automation • Technical transfer requirements Understand the (Every) Process
- 13. FACILITY DESIGN DEVELOPMENT • EXISTING • Breathing Air • Process Water • Nitrogen 10# • Nitrogen 85# • Plant Steam • Condensate • HTF S/R • Process Vent • Hydraulic Fluid • WFO UTILITY REQUIREMENTS Adjacent Processes – In Use Shut downs & Planning across multiple projects simultaneous Survey Confirmation Min Qualified Systems PID Field
- 15. FACILITY DESIGN DEVELOPMENT UTILITY REQUIREMENTS BATCH CONTINUOUS • Limited HE Area • Scale Up‐ Space • Larger Volume Rinse / Chase • Process Water • Surface Area to Volume Ratio Increase • Scale Up In Place • Min Volume Rinse / Chase
- 17. FACILITY DESIGN DEVELOPMENT PHYSICAL CONSTRAINTS 127.5” To Underside 104.5” Process Plant 23” of Clearance ‐ Exhaust Duct ‐ Sprinkler ‐ Wire Duct ‐ HTF S/R ‐ Cooling Water ‐ N10, N85, &N500 ‐ Vent ‐ CA
- 19. FACILITY DESIGN DEVELOPMENT • BEFORE PHYSICAL CONSTRAINTS ~16’ X 16’ Area: • 2 – 50 & 2 – 200 Gallon GL Rx • 2 – Hydraulic Ag • Jkt Circulation Pumps • Jkt HX • Condenser 4 Reactor Bays – Thru Floor Delta V MCP
- 20. FACILITY DESIGN DEVELOPMENT • AFTER PHYSICAL CONSTRAINTS ~16’ X 16’ Area: • 8 Vessels – upto 1600L (350 G) • Supply Materials Product and Waste Collection • 4 – Utility Panels • 4 – Filter Stations and Automated Valve Panels w/ 4 future spaces avail • LEVs
- 21. FACILITY DESIGN DEVELOPMENT • Analysis Provided: • Wall • Floors • Relief Panels BLAST ANALYSIS Blast Hazard Analysis and Preliminary Dynamic Structural Analysis Quantify Any Structural or Near Yield Hazards Adequate for Intended Operations Doors EXCEPT: Unable to Confirm Existing Door Design
- 22. FACILITY DESIGN DEVELOPMENT • Enclosure Components not Electrically Classified • Raw Material / Product Staged in Adjacent Area ADDITIONAL SAFETY /HAZARD Hazard Area Classification HAC Vessel Design • Tipping Calcs • Not Plausible Mechanical Design • LEL Detection • Secondary Containment • Max Door Opening
- 23. FACILITY DESIGN DEVELOPMENT • FLEXIBILITY • Utility Panels • Transfer Panels • Hose Connections/Management • 360 Access for entire plant • CONSIDERATIONS • Consistent Design • Utilize similar components • Organization FLEXIBLE DESIGN Adapt to Future Needs of Continuous Processing
- 25. FACILITY DESIGN DEVELOPMENT • Panel Design • Compact • Single Source • Experience • Benefits • Consistency • Standardized Approach • Design portion completed for future install PACKAGED SYSTEMS
- 26. FACILITY DESIGN DEVELOPMENT • Transfer Hoses & Panels • Compact • Minimum Floor Space PACKAGED SYSTEMS
- 27. FACILITY DESIGN DEVELOPMENT • Hose • Location • Visual • Separated HOSE MANAGEMENT
- 28. PROJECT MANAGEMENT • PM 101 – Deliver project on time, in budget, and meeting all functional requirements • 1st of its kind – didn't really know what we had or how best to utilize • No precedent for pilot plant design…many design evolutions • Schedule – very aggressive…. at first 6‐9 months • As the team grasped the larger potential we realized it was better to get it right than to rush…more budget and 2 years to implement. SCHEDULE
- 29. PROJECT MANAGEMENT • Performing renovations in an operating plant – windows for shutdowns, dust control, etc. • Took out the batch reactors, pulled up acid brick floor, closed floor openings laid new ESD epoxy flooring. • Change paradigm of space utilization – (re)connect accessibility and increased visibility for the operators. RETROFIT CONCERNS
- 32. • Established VWP early • Developed Project Master Validation Plan early start but took a while to complete. • Challenges: • URS was purposely not defined at beginning of project….rather it evolved as the team grasped the capabilities of the technology and how to apply it. • Automation – Delta V was a GMP qualified system, project was able to segregate the work‐in‐progress from the existing qualified system. PROJECT MANAGEMENT CQV
- 33. PROJECT MANAGEMENT CQV VALIDATION PLAN DELTA V ‐ CC (QA) SFAT PROCONE HFAT ACI Utilities & Infrastructure Demolition / Construction (GEP & GMP) Facility & Utility Commissioning (GEP) FCPP FAT Zeton Shipping Install Process Plant GSK UP Loop Checks QA Calibrattion QA Process Commissioning (Pre‐GMP) SubstantialCompletion for NON‐GMP Operation 15‐Aug‐2016 IQ/OQ ‐ Software & Hardware Finalize & Execute (QA) Shipping
- 34. • Key component of the Commissioning effort • HFAT – new control panels ‐ locally • SFAT – software configuration and graphics ‐ locally • Process FAT – shipped control panel and Delta V server with the program files to Mfr facility. • We learned a lot during the 2 week FAT about what we had purchased!! FATs PROJECT MANAGEMENT
- 37. • Site Commissioning – essentially a repeat of the FAT…learn by repetition! • The team was getting very proficient at using their new toy! • Current Status – Cx complete – ready for development work. • Qualification will be executed once a specific GMP campaign is scheduled. Installation PROJECT MANAGEMENT
- 38. Installation ‐ Before PROJECT MANAGEMENT 2nd Floor 1st Floor
- 39. Installation ‐ After PROJECT MANAGEMENT 2nd Floor – North Wall 1st Floor