Why, When, How to Benefit from
Modular Projects
Lena Lasarzewski, Pharmadule Inc.
January 15, 2008
Agenda
• What is a modular project?
• Advantages with modular
construction
• Challenges with modular
construction
• When to choose a modular approach
• How to execute a modular project
• Conclusions
• Questions/Discussion
Modular Projects
• Manufactured – not constructed
• The modules (building blocks) form
the complete facility - all process and
utlility equipment etc. is already
installed
Advantages of Modular Projects
•
•
•
•
•
•
•
•
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Cycle time reduction
• 6-12+ months shorter than conventional
Cost management
• Fixed price, change control
Proven designs
• More than 50 pharma/biotech plants delivered
Clean manufacturing environment
• 75-80% of project in Supplier’s workshops
High quality design and construction
• Crafts personnel have been trained on a large number of
pharmaceutical and biotech projects
• Responsibility from design through validation
Integrated Commissioning/Qualification/Validation
Systems have been tested over a large number of projects
Minimal site disturbances, increased safety
• Shorter time, less people on site
Economy
• Net Present Value
Schedule
Schedule Comparison
Comparison –– Conventional
Conventional vs.
vs.
Integrated
Integrated Modular
Modular Project
Project Integrated
Conventional
Well Executed
Reference
Modular
F&F 2004
F&F 2006
Target
0
-5
-10
-12
-15
Months
36-20=16
-16.5
-18
-20
-25
-30
-35
-36
-40
Fill Finish Approx. 30’ – 40’ K sqf
Detail Design - OQ
Challenges of Modular Projects
• Shorter schedule
• Fast, efficient decision-making
• Front-load planning and engineering
• Understand needs - URS
• Integrated validation
• QA and Compliance involvement from start
• Embrace change
• Different, much faster, project execution (paradigm shift
in project execution)
• Execution moves quickly
• Fast, efficient turn-around, impact of changes
• Personnel offsite
• Increased Travel
What Do We Mean By Modular Concept
Large open area
Installation of Large Process Equipment
Modular Fabrication
Length: 13,35 (44’)
Height: 4,1 m (13’)
Rational fabrication under
controlled indoor conditions.
Re- assembly at clients site.
Width: 4,45 m (14’ 8’’)
Weight: 15-35 tons
Area: ~ 60 m2 (650 F2)
Compressed Implementation Schedule
SUPPLIER ACTIVITIES
Conceptual/
Basic Design
Detailed Design
& Engineering
Signing of Contract
Procurement
Plant
Fabrication
Installation of
equipment
Assembly, Tests (IQ)
& GMP Inspection
Operator
Training
Plant
Disassembly
AT SUPPLIER’S SITE
Shipment
AT OWNER’S SITE
OWNER ACTIVITIES
A&E
Liaison
Warehouse &
Administr. bldg
Foundation and
sewage system
Reassembly
of Plant
Commissioning
IQ OQ
Electricity and
water supply
Validation/PQ
Operation
Production
Modular Fabrication
Disassembly and Transportation
Transportation to Owner’s Site
Re-Assembly at Owner’s Site
Re-Assembly at Owner’s Site
Decision For a Modular Approach
• Should be made in conceptual phase
• Evaluate project criteria
• Complexity of project
• Timing (product, process, market
demands)
• Site conditions
• Owner’s capabilities/organization
• Evaluate net present value
• Evaluate risk
Project Drivers towards Modular Decision
• Predictability
• High level of assurity to successfully to complete a
project on time and on budget
• Schedule
• Speed to market, delayed investment,
permitting
• Site
• Safety, security, disturbancies, labor, weather
• Owner Resources
• Flexibility
• Phased expansion, process modifications,
moving facility
• Project management
• Complexity, quality & risk concerns, financial
How To Execute Modular Projects
• Assemble full team at project inception
• Assign clear roles, responsibilities and organization
• Plan early
• Complete conceptual planning first
• Decision timing is most important
- Empowerment
• Plan the work process for flexibility
• Efficient change order process
• Provide adequate field staff
• Embrace the modular concept
• Partner with supplier
• Form a joint project team with shared goals
Completed Facilities
Biotech Facilities
Sterile Facilities
Conclusion
• A Modular Approach Can Provide
Higher Total Return On Investment
• Shorter Schedule
• Less Risk
• Higher Safety
• Make Modular Decision Early
• Staff For Rapid Project Execution
• Embrace The Modular Concept
• New project execution methodology
• Integrated validation
Questions/Discussion
Thank You