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Design/Build of a
Smallpox Vaccine Facility
BL2/3 Fill FinishO’NEAL, Inc CBL WHITING-TURNER
Introduction
Introduction Brent Noel, O’Neal Vice President
The Project The Players
Michael Molloy, Director of Engineering
Rick Ayd, Senior Project Manager
William Porter, Process Engineer
Background Briefing
Proposal to combat bio-terrorism
Contract competition
Acambis, Baxter, CBL Team
CBL Already has capital expansion plans
Project Team Selection
Chesapeake Bay Chapter ISPE Members
Whiting-Turner, Rick Ayd – Chapter President
O’Neal, Bill DeLoache - CBA Board Member
CBL, Michael Molloy - CBA SecretaryThe Preliminary Layout
Concept presentation to Acambis Team
Handshake between CBL & WT
“How much could we spend in a week?”Michael Molloy, Dir. of Eng., CBL
Chesapeake Bay Chapter ISPE Members
Whiting-Turner, Rick Ayd – Chapter President
O’Neal, Bill DeLoache - CBA Board Member
CBL, Michael Molloy - CBA SecretaryThe Preliminary Layout
Concept presentation to Acambis Team
Handshake between CBL & WT
“How much could we spend in a week?”Michael Molloy, Dir. of Eng., CBL
Project Team Selection
Project Team Selection
Chesapeake Bay Chapter ISPE Members
Whiting-Turner, Rick Ayd – Chapter President
O’Neal, Bill DeLoache - CBA Board Member
CBL, Michael Molloy - CBA SecretaryThe Preliminary Layout
Concept presentation to Acambis Team
Handshake between CBL & WT
“How much could we spend in a week?”Michael Molloy, Dir. of Eng., CBL
Begin manufacturing the vaccine by 2/15/02
The Beginning
The Concept becomes the Goal
The Challenge:
“The facility design can’t change if we are going to meet the deadline”
Rick Ayd, Sr. Project Manager-WT
Design & Construct a Fill Finish BL2/3 Manufacturing Facility by
1/15/02 - 75 DAYS
The equipment search
Day trips to vendor
Around the world in 15 days
Gentleman’s agreement to supply equipment
Can we use existing CBL equipment?
Don’t blink – An hour is a day; a day is a week!
“Rick, next time you decide to add a building; can you let me know first”
John Botek, CBL, COO
Off To The Races
Off To The Races
The equipment search
Day trips to vendor
Around the world in 15 days
Gentleman’s agreement to supply equipment
Can we use existing CBL equipment?
Don’t blink – An hour is a day; a day is a week!
“Rick, next time you decide to add a building; can you let me know first”
John Botek, CBL, COO
First Things First
Assembled Team
Whiting-Turner
O’Neal Design & Engineering
CBL Management
Hand picked subcontractors
Hand picked vendors
Subcontractors Vendors
Tom Rice President & CEOJohn Botek COOVicki Wolff-Long VP of Analytical Services and Project ManagementMichael Molloy Director of EngineeringElizabeth Troll Director of Quality AssuranceNarlin Beaty CTO & ValidationByron Simpson Director of ProductionSam Mancuso Director of Continuous ImprovementFred Anderson Plant Manager (Facilities)Scott Emerick Process EngineerScott Brown Process Controls Engineer
Ayd, Rick Senior Project ManagerAllison, Herb Mechanical Engineer – HVAC SupportBazzle, Lorne SuperintendentBeschorner, Bill Project Engineer – Equip. Procurement, CaseworkCampbell, Eric Project Engineer – Process SystemsClark, Dick Superintendent – Quality ControlComire, Jay Project ManagerGagne, Bruce Project Engineer – Concrete, D/F/H, SpecialtiesGingue, Pierre Project Engineer – Process SystemsMcCarter, Meredith Project Engineer – HVAC, Plumbing, PaintingMoore, Nate Project Engineer – Steel, DrywallOcheltree, Rich Superintendent – SafetyReid, James Project Engineer – Roofing, Flooring, CaulkingScalora, Enzo Project ManagerSchaefer, Fred Mechanical Superintendent – Mech. & Process Systems
Brock, Alan Team LeaderBrown, Bill Design/DrafterDashnaw, Ed Process EngineerDeLoache, Bill Project LeaderEvans, Rick Structural EngineerHenson, Walter Mechanical EngineerKing, Michael ArchitectLewis, John Process EngineerLewis, Ralph Electrical EngineerManaher, Kevin Mechanical EngineerNoel, Brent Process EngineerPercifield, Jerry Laboratory ArchitectPorter, Bill Process EngineerRamseur, Bubba Project ManagerStansell, Fred Project Leader
Subcontractors Vendors
Support
Selection process of subcontractorsCan you devote 3 months, 24/7 to this project?How many workers can you have here tomorrow?Construction done - 1/15/02
Are you up to the challenge?Selection process of Vendors
How fast can you have the equipment here?Need best quality with best delivery date
SUBCONTRACTOR TEAM FOR SMALLPOX FACILITY
Concrete Work Whiting-TurnerMasonry Banner MasonrySteel Fabricators Whiting-TurnerSteel Erectors Whiting-TurnerMisc. Stainless Steel Warren Ehret
CompanyCarpentry Whiting-TurnerRoofing Warren Ehret CompanyCaulking & Waterproofing M.N.P. WaterproofingDoor/Frame/Hardware (Furn) Custom
Engineered OpeningsDoor/Frame/Hard (Install) Centerline ConstructionDoor Controls ARK ControlsDrywall & Ceiling Centerline ConstructionPainting Paras PaintingEpoxy Flooring StonhardSheet Vinyl Flooring Specialty Interior
ConstructionLab Casework VWR InternationalSheetmetal/Ductwork Supply – Galvanized Warren Ehret
Company xhaust – Stainless Steel Stromberg Metal
WorksBuilding Mgmt. System SiemensMechanical/Plumbing Whiting-TurnerProcess Piping Whiting-TurnerDuct/Pipe Insulation Hudak’s
InsulationProcess Controls Valley InstrumentsPassivation Active ChemicalFilter Install & Testing Micro CleanAir/Water Balancing Baltimore Air
BalanceElectrical F.B. Harding
Support
Selection process of subcontractorsCan you devote 3 months, 24/7 to this project?How many workers can you have here tomorrow?Construction done - 1/15/02
Are you up to the challenge?Selection process of Vendors
How fast can you have the equipment here?Need best quality with best delivery date
Support
Selection process of subcontractorsCan you devote 3 months, 24/7 to this project?How many workers can you have here tomorrow?Construction done - 1/15/02
Are you up to the challenge?Selection process of Vendors
How fast can you have the equipment here?Need best quality with best delivery date
VENDOR TEAM FOR SMALLPOX FACILITY Acambis Product TankAccraply Labeling MachineAlban Rentals Plant Chillers, Plant Cooling Towers, Plant BoilerAtlantic Technologies Sterility IncubatorsBaker Fume hoods for labBocsh Vial Filler, Trayloader, Transfer ConveyorBTH Company Biowaste Deactivation Tank, Biowaste Sump Tank, WFI Pump, WFI Heat ExchangerBushong Industrials Polyproylene SumpCamfil Farr Exhaust Filters & Frames, ULPA Filters & HousingsClimate Technologies -20 C Freezers, 2-8 C Cold Rooms, 35 C Warm RoomClimet Technologies Portable Particle Counter SystemContinential Equip, Non-Equipment Decon AutoclaveDan Rainville & Assoc. Air Handling Units, Humdifier, VFD’s for AHU and Exhaust Fans, Steam ValvesDS Pipe & Supply Piping MaterialsEngineered Piping Products Process Piping MaterialsFerguson’s UG & Process Piping MaterialFluid Flow WFI & Biowaste Filters & HousingFP Development Inspection Stations, Bidirectional Tables, Accumulating Conveyor, Inkjet Marking System, Thru-Wall Conveyor, Trayloader, TurntablesGarvey Vial WasherGenesis WestcapperGetinge Equipment Decon AutoclaveJames M. Pleasants Co. Recirculating PumpsKaestner Company Stainless Steel FittingsL.M. Pond Dampers & LouversMatheson Tri-Gas Nitrogen ManifoldMueller Pure Steam GeneratorPakon Engineering Products WFI Pipe, PBM Valves, Steam TrapsPBM ValvesTwin City Fan & Blower Exhaust FanSentinel Diaphragm ValvesSwagelok – Balt. Valve & Fitting Valves & FittingsTencarva Machinery Co. Air Compressor, Air Dryer, Air ReceiverTFC/Filtrex Bag In & Bag Out Filter & HousingTrane Co. Rooftop UnitTri-State Techinical Sales Valves & FittingsVeltek Associates SMA System
Support
Selection process of subcontractorsCan you devote 3 months, 24/7 to this project?How many workers can you have here tomorrow?Construction done - 1/15/02
Are you up to the challenge?Selection process of Vendors
How fast can you have the equipment here?Need best quality with best delivery date
Support
Selection process of subcontractorsCan you devote 3 months, 24/7 to this project?How many workers can you have here tomorrow?Construction done - 1/15/02
Are you up to the challenge?Selection process of Vendors
How fast can you have the equipment here?Need best quality with best delivery date
MeetingsDaily meetings with owner & design teamContractor team meetings in late eveningCoordination meetings every day
ShiftsWorked 7 days a weekTwo 10-12 hour shifts daily
Daily Routine
MeetingsDaily meetings with owner & design teamContractor team meetings in late eveningCoordination meetings every day
ShiftsWorked 7 days a weekTwo 10-12 hour shifts daily
Daily Routine
Construction
Fabrication/WarehouseFabrication of steel on siteFabrication of piping systems on site55K SF bldg. to store material & equipment
How did it work?Team dedicationConfidenceCoordination of all parties involvedCooperation of City of Baltimore, BGE, & BDC
Construction
Fabrication/WarehouseFabrication of steel on siteFabrication of piping systems on site55K SF bldg. to store material & equipment
How did it work?Team dedicationConfidenceCoordination of all parties involvedCooperation of City of Baltimore, BGE, & BDC
Construction
Fabrication/WarehouseFabrication of steel on siteFabrication of piping systems on site55K SF bldg. to store material & equipment
How did it work?Team dedicationConfidenceCoordination of all parties involvedCooperation of City of Baltimore, BGE, & BDC
Construction
Fabrication/WarehouseFabrication of steel on siteFabrication of piping systems on site55K SF bldg. to store material & equipment
How did it work?Team dedicationConfidenceCoordination of all parties involvedCooperation of City of Baltimore, BGE, & BDC
Construction
Fabrication/WarehouseFabrication of steel on siteFabrication of piping systems on site55K SF bldg. to store material & equipment
How did it work?Team dedicationConfidenceCoordination of all parties involvedCooperation of City of Baltimore, BGE, & BDC
Timeline11-1-01: Notice to Proceed11-5-01: Programming & Conceptual Design11-6-01: Expand Seaboards Bldg. for Utilities11-7-01: Start Construction11-8-01: Procurement of HVAC11-15-01: Procurement of Mfg. Equipment11-19-01: Complete Production Area Steel12-3-01: Begin Temp. Plant Utilities Installation12-20-01: Start Lab Design12-21-01: Start Lab Construction12-27-01: Utility Start Up1-11-02: HVAC System Operational1-15-02: Substantially Complete
Timeline
11-8-0111-1-0111-5-0111-6-01
11-7-01 11-15-01 11-19-01 12-3-0112-20-0112-21-02
12-27-01 1-11-02 1-15-02
Existing Shell DimensionsAdded utility buildingAdded lab spaceEquipment spaces tight
Learning CurveMultiple Changes in Process Equipment
Three different fillersVHP with isolator was in then outMany changes due to availability
No Product Specifications
Technical Hurdles
Existing Shell DimensionsAdded utility buildingAdded lab spaceEquipment spaces tight
Learning CurveMultiple Changes in Process Equipment
Three different fillersVHP with isolator was in then outMany changes due to availability
No Product Specifications
Technical Hurdles
Dual criteria for BL-2 & BL-3 upgradeable
Process sewers & kill tanks
Sanitize chemically without heat
CIP - SIP product delivery system
Clean room exit shower
Design Features
Dual criteria for BL-2 & BL-3 upgradeable
Process sewers & kill tanks
Sanitize chemically without heat
CIP - SIP product delivery system
Clean room exit shower
Design Features
Used Equipment
Stored EQ degrades over time
Freeze dryer hard drive
New, tighter control requirements
Used equipment may have modified
Documents may not be available
Number of available trained operators/mechanics
Lack of available spare parts
New Equipment
FAT/SAT
Distance from site
Training
Not in control of production
Higher first cost
Lessons Learned
What we would do different next time:Better documentation of design processGenerate more meeting minutesUse small redundant utility systemsClear definition of product supply chain
Lessons Learned
What we did right:Direct hiresConstant communicationCatered lunch onsiteHired the right level of experienced peopleDraw from the expertise of ISPERight size organizationsMade FDA & CDC comfortable with the processInstalled a wireless network onsite for web & emailOn site design team & office