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