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ISPE Nordic 1
Innovative Design &Innovative Design &
Fast Track Project ImplementationFast Track Project Implementation
JanJan LiljaLilja Director Director
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AgendaAgenda
n Case Study: Turn-Key supply of a Modular Aseptic
Manufacturing Facility in 17 months
n Conclusions
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The Modular ConceptThe Modular Concept – – An EnablingAn Enabling
TechnologyTechnologynModular design and fabrication
The term Modular is a wide-ranging concept. In this case it meansturn-key supply of complete facilities including all installations,
designed, built and IQ:ed off site.
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The Modular ConceptThe Modular Concept – – An EnablingAn Enabling
TechnologyTechnologyn The modular approach is today used for fast track, flexible
and predictable turn-key project delivery
- Global process-oriented design solutions (cGMP)
- Customized standardization
- Integrated validation approach from start of conceptual design
- Off-site construction with higher productivity and predictability
- Fabrication takes place in parallel with permitting and ground-
breaking work
- Same experienced fabrication team independent of final location
- Allows for full installation and testing off-site
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The Value of Fast Project ImplementationThe Value of Fast Project Implementation
Conventional Project
Fast Track Project
Conventional Project
Fast Track Project
Fast Track Project
Conventional Project
Fast Track Project
Conventional Project
Fast Track Project
Less risk at decision point- Clinical trials results
- More info about market conditions
- Better developed process
Efficient use of financial resources
Same Completion Date with Later Start
Same Start with Earlier Completion Date
Faster-to-Market
Earlier return on investment
Less use of resources Defined/known process
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TheThe Modular Modular ConceptConcept – – A FlexibleA Flexible
TechnologyTechnology
n Future expansion
Phased investment with minimal down-time (Baxter)
n Technology Transfer
From Center of Excellence to local market
Product transfer between identical facilities
n Moving the facility
Re-sale (Sweden to Grindeks, Latvia), (Vagos, Estonia to BMS,Moscow)
Re-location (twice within Sweden, Astra Zeneca)
Installation of long lead equipment at vendor s workshop (AstraZeneca, Genentech)
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MovingMoving thethe facilityfacility
n Cost of relocation
Estimated cost for relocation isabout 10-15% of the initialinvestment (manufacturing
building including process,clean utility and HVACequipment and systems)
n Time schedule for relocation
Estimated time required for
relocation is about 4-8 monthsincluding disassembly,transport, reassembly andrequalification (IQ/OQ)
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Case Study: TurnCase Study: Turn--key supply of a Modular key supply of a Modular
Aseptic Manufacturing FacilityAseptic Manufacturing Facility
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The CompanyThe Company’’s Project Requirementss Project Requirements
n The investment should relieve demands on existing facilities andavoid potential delays/shutdown of operations
n Design to higher seismic importance (2,5 in California, SanFrancisco)
n Design for 1 batch fill every 24 hours
n Install and start 1 pc 28 sqm lyo, prepare for addition of a second
n Clean utility generation included in new facility, other utilities fromexisting site infrastructure
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The CompanyThe Company’’s Guiding Principless Guiding Principles
n Minimize distraction on current projects and Operations
Deliver the project using off-site modular facility technology withan integrated project approach
Utilize off-site installation of long lead equipment
n Utilize vendor standards (engineering, construction anddocumentation)
n Small team that is empowered to make decisions and haveaccess to senior level management
Clear and prompt decision making
Decisions made within 24 hours
n Leverage vendor validation capabilities
Risk assessment based approach to validation
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Client Project ObjectivesClient Project Objectives
n Deliver a manufacturing facility
Cost to be equal to conventional alternative
Speed is a critical success factor
On time, through tailor-made, flexible approach
Licensed (Fda) in 28 months for $65 M
Licensed for 1 liquid product
Licensable for full product portfolio
Prepared for future expansion
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Project ScopeProject Scope
Size of facility 3,200 sqm, including process areas, mechanical areas for clean utilities and HVAC, lockers,cafeteria, goods receiving area with coldstorage
- Water pre-treatment equipment (outside of modular building)
- 1 WFI still- 1 Clean Steam Generator - 1 Vial washer and sterilizing tunnel- 1 Vial filler - 2 vial cappers- 1 lyophilizer
- 2 bulk-prep stations (including glycol cooling)- 1 CIP/SIP station for movable tanks
- 6 air handling systems (including automation)- Information management system (batch data collection) GAMP
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17 months from start Detailed Design to17 months from start Detailed Design to
OQ completeOQ completeID Task Name
1 Revised Plan
2 Project Budget Set
3 Board approval
4 Basic Design
5 Detail Design
6 Fabrication7 Fill Line testing
8 Pack and ship Support
9 Pack and ship process
10 1st module arrivse on
11 Permitting
12 Foundation and Site W
13 Erect modules
14 Re-assembly and start
15 Qualification through O
16 PQ
17 Media Fills
18 Qaul Lots
19 Stability
20 FDA review and appro
2/1
2/8
10/17
1/9
O N DeJaFeM ApM JuJuAuSeO N D JaF M ApM JuJuAuSeO N D JaFeM ApM Ju JuAu
2005 2006 2007
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BatchBatch division of design anddivision of design and fabricationfabrication
n Define and focus on critical areasof the facility
n Building separated in support area
and process area to allow for simplified access
n Building divided into 7 batches
n The lyophilization area treated as a
separate batch to allow for earlydispatch of modules to the supplier of the lyophilizer
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Divide building for simplified accessDivide building for simplified access
Process Area
Support Area
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PrePre--assembled facility at modular assembled facility at modular
supplier supplier ’’s workshops workshop
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Facility required to blend in withFacility required to blend in with
surroundingssurroundings
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StartStart--upup at theat the modular modular supplier supplier ’’ss
workshopworkshopn The facility was assembled at the
workshop (except lyo)
n Start-up and FAT of the followingsystems:
Filling line
WFI system
CIP system
BAS system
IMS system
n Tests documented according toGDP to use for validation
n Building and Fire officialinspections
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Installation of the vial washer Installation of the vial washer
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StartStart--up of the filling machineup of the filling machine
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Testing of the filling lineTesting of the filling line
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Disassembly and preparation for Disassembly and preparation for
shipmentshipment
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Innovative approachInnovative approach
n Move (part of) the facility to the vendor
Use experienced vendor resources
Use workshop facilities
Use commissioning capabilities (temporary utilities, etc.)
Do a thorough debugging and start-up at vendor
Make IQ and part of OQ tests in final installation at vendor
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LyoLyo in a boxin a box
To shorten the time schedule and minimize
risk and testing, a part of the building was
sent to BOC Edwards.
The complete lyophilizer system (chamber,condensor and Compressor skid) wasinstalled directly into the modules and alltesting was performed in their work shop.
Meanwhile the rest of the building wasalready on its way to the clients site.
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Project Delivery GeographyProject Delivery Geography
SwedenTonawanda
San Francisco
HollandSweden
Tonawanda
San Francisco
Holland
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Modules atModules at lyolyo supplier supplier ’’s workshops workshop
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Modules stacked up withModules stacked up with lyolyo installedinstalled
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FacilityFacility on finalon final sitesite readyready for for dockingdocking of of
thethe
lyolyo
modulesmodules
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Filling line on siteFilling line on site
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AchievementsAchievements
n Able to absorb 3 months schedule delay in permits
n Modular building including all process and clean utility equipment
designed, fabricated and tested in 10 months
n Substantial start up, commissioning and testing completed in theworkshops of Pharmadule and BOC Edwards
n Training executed and operational documentation completed before
shipment to site
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ConclusionsConclusions
The Modular concept allows for different kinds of FLEXIBILITY
OWNER:
- Early finish or deferred start
- Allocation period of capital expenditure optimized- Much faster depreciation possibilities of the facility (not fixed asset)
DESIGN & FABRICATION:
- Customized solution, standardized approach (20/80)
- Off-site construction in several locations (executor, vendors)- Batch approach to fabrication (independent blocks)
- Independent site preparation work (not on critical path)
- Less disturbances for ongoing work on site
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ConclusionsConclusions
The Modular concept allows for different kinds of FLEXIBILITY
PROJECT TEAM
- Less client resources required- Focus on core competences
* Pharmadule (design, execution, validation)* Vendors (installation & testing)* Client (URS, process, PQ, manufacturing start-up)
FUTURE
- Built in flexibility for new equipment/processes- Ease of expansion with minimal down-time- Re-location at existing or to new site
Result: FLEXIBLE & FAST(ER) PROJECT Implementation
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Thank you for the attention!
Questions?
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