primary continuous processing retrofit
TRANSCRIPT
PRIMARY CONTINUOUS PROCESS UPGRADE
Shamai Cylich, Arcadis, Sr. Project ManagerScott Cheeseman, GSK, Sr. Process EngineerSteve Walter Hargrove Life Sciences, Process Technology Leader
PRESENTATION OUTLINE• Scott
Process Design Development
• Steve
Facility Design Development
• Shamai
Project Management
Closing
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
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
PROCESS DESIGN DEVELOPMENT
BATCH CONTINUOUS
PROCESS DESIGN DEVELOPMENT
Safety
Flammables
Containment
Personal Protection
Process Safety
Flexibility
Unit Operations
Equipment Train
Breakdown/ Turn‐around
Access to Utilities
CONSIDERATIONS
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
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
PROCESS DESIGN DEVELOPMENT
Models
PROCESS DESIGN DEVELOPMENTModels
PROCESS DESIGN DEVELOPMENTModels
UTILITY REQUIREMENTS
PHYSICAL LIMITATIONS
BLAST CONSTRAINTS
FLEXIBLE DESIGN
PACKAGED SYSTEMS
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
ELIM
INAT
ED
FACILITY DESIGN DEVELOPMENTUTILITY REQUIREMENTS
BATCH CONTINUOUS
Plant Steam & Condensate
Hydraulic Sys (Agitators)
Existing HTF Sys: Syltherm‐25C to 160C
Required Multiple
Simultaneous Differing Temps
Limited Temp Range
Single Source
FACILITY DESIGN DEVELOPMENTUTILITY 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
FACILITY DESIGN DEVELOPMENTPHYSICAL CONSTRAINTS
32 Process Conn HT Kit (3x)
Duct, Data, Drain,
Sprinkler
FACILITY DESIGN DEVELOPMENTPHYSICAL 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
FACILITY DESIGN DEVELOPMENTPHYSICAL CONSTRAINTS
Valve & Instr Access
Electrical Clearances
Mechanical Access
FACILITY DESIGN DEVELOPMENT
• BEFOREPHYSICAL 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
FACILITY DESIGN DEVELOPMENT
• AFTERPHYSICAL 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
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
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
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
FACILITY DESIGN DEVELOPMENTFLEXIBLE DESIGN
FACILITY DESIGN DEVELOPMENT
• Panel Design• Compact • Single Source• Experience
• Benefits• Consistency• Standardized Approach• Design portion completed for future install
PACKAGED SYSTEMS
FACILITY DESIGN DEVELOPMENT
• Transfer Hoses & Panels• Compact • Minimum Floor Space
PACKAGED SYSTEMS
FACILITY DESIGN DEVELOPMENT
• Hose • Location • Visual • Separated
HOSE MANAGEMENT
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
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
PROJECT MANAGEMENTMockups
Mock‐up for VIP Tour
Rough Scale Mock‐up
Final True‐Scale Mock‐up
PROJECT MANAGEMENTRisk Management
HAZOP
Concept Design, Design Complete and Construction
Limited to CP, Utility and
Infrastructure
PRA’s specific to chemistry
EHS, Auto, Proc Eng, Ops, PM
226 Action Items
• 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 MANAGEMENTCQV
PROJECT MANAGEMENTCQV
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
CalibrattionQA
Process Commissioning (Pre‐GMP) Su
bstantialCom
pletion for N
ON‐GMP
Ope
ratio
n 15
‐Aug
‐2016
IQ/OQ ‐ Software & Hardware Finalize &
Execute (QA)
Shipping
• 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
FAT ‐ Process
PROJECT MANAGEMENT
Continuous Plant Electrical/Control Panels Smoke testing
Installation
PROJECT MANAGEMENT
Skid Arrived!!Just fit through the roll door
• 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
Installation ‐ Before
PROJECT MANAGEMENT
2nd Floor 1st Floor
Installation ‐ After
PROJECT MANAGEMENT
2nd Floor – North Wall 1st Floor