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					     Design/Build
          of a
Smallpox Vaccine Facility
              BL2/3 Fill Finish
O’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 Secretary
 The 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
 Chesapeake Bay Chapter ISPE Members
    Whiting-Turner, Rick Ayd – Chapter President
    O’Neal, Bill DeLoache - CBA Board Member
    CBL, Michael Molloy - CBA Secretary
 The 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
 Chesapeake Bay Chapter ISPE Members
    Whiting-Turner, Rick Ayd – Chapter President
    O’Neal, Bill DeLoache - CBA Board Member
    CBL, Michael Molloy - CBA Secretary
 The 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
                           The Beginning
The Concept becomes the Goal

Begin manufacturing the vaccine by 2/15/02

The Challenge:

               Design & Construct a
   Fill Finish BL2/3 Manufacturing Facility by
                1/15/02 - 75 DAYS
      “The facility design can’t change
   if we are going to meet the deadline”
                           Rick Ayd, Sr. Project Manager-WT
                     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
                     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 & CEO
John Botek         COO
Vicki Wolff-Long   VP of Analytical Services and Project Management
Michael Molloy     Director of Engineering
Elizabeth Troll    Director of Quality Assurance
Narlin Beaty       CTO & Validation
Byron Simpson      Director of Production
Sam Mancuso        Director of Continuous Improvement
Fred Anderson      Plant Manager (Facilities)
Scott Emerick      Process Engineer
Scott Brown        Process Controls Engineer
Ayd, Rick                 Senior Project Manager
Allison, Herb Mechanical Engineer – HVAC Support
Bazzle, Lorne             Superintendent
Beschorner, Bill          Project Engineer – Equip. Procurement, Casework
Campbell, Eric            Project Engineer – Process Systems
Clark, Dick               Superintendent – Quality Control
Comire, Jay               Project Manager
Gagne, Bruce              Project Engineer – Concrete, D/F/H, Specialties
Gingue, Pierre            Project Engineer – Process Systems
McCarter, Meredith        Project Engineer – HVAC, Plumbing, Painting
Moore, Nate               Project Engineer – Steel, Drywall
Ocheltree, Rich           Superintendent – Safety
Reid, James               Project Engineer – Roofing, Flooring, Caulking
Scalora, Enzo             Project Manager
Schaefer, Fred            Mechanical Superintendent – Mech. & Process Systems
Brock, Alan                Team Leader
Brown, Bill                Design/Drafter
Dashnaw, Ed Process Engineer
DeLoache, Bill             Project Leader
Evans, Rick                Structural Engineer
Henson, Walter             Mechanical Engineer
King, MichaelArchitect
Lewis, John                Process Engineer
Lewis, Ralph Electrical Engineer
Manaher, Kevin             Mechanical Engineer
Noel, Brent                Process Engineer
Percifield, Jerry          Laboratory Architect
Porter, Bill               Process Engineer
Ramseur, Bubba             Project Manager
Stansell, Fred             Project Leader
Subcontractors   Vendors
   SUBCONTRACTOR TEAM FOR SMALLPOX FACILITY
       Concrete Work
       Masonry
                                    Whiting-Turner
                                    Banner Masonry
                                                             Support
       Steel Fabricators            Whiting-Turner
       Steel Erectors               Whiting-Turner

Selection process of subcontractors
       Misc. Stainless Steel
       Carpentry
                                    Warren Ehret Company
                                    Whiting-Turner
       Roofing                      Warren Ehret Company
  Can you devote 3 months, 24/7 to this project?
       Caulking & Waterproofing     M.N.P. Waterproofing
       Door/Frame/Hardware (Furn)   Custom Engineered Openings
  How many workers can you have here tomorrow?
       Door/Frame/Hard (Install)
       Door Controls
                                    Centerline Construction
                                    ARK Controls
  Construction done - 1/15/02
       Drywall & Ceiling
       Painting
                                    Centerline Construction
                                    Paras Painting
       Epoxy Flooring               Stonhard
Are you up to the challenge?
       Sheet Vinyl Flooring
       Lab Casework
                                    Specialty Interior Construction
                                    VWR International
       Sheetmetal/Ductwork
Selection process of Vendors Company
                        Warren Ehret
        Supply – Galvanized
        xhaust – Stainless Steel    Stromberg Metal Works
  How fast can you have the equipment here?
       Building Mgmt. System
       Mechanical/Plumbing
                                    Siemens
                                    Whiting-Turner
  Need best quality with best delivery date
       Process Piping
       Duct/Pipe Insulation
                                    Whiting-Turner
                                    Hudak’s Insulation
       Process Controls             Valley Instruments
       Passivation                  Active Chemical
       Filter Install & Testing     Micro Clean
       Air/Water Balancing          Baltimore Air Balance
       Electrical                   F.B. Harding
                                      Support
Selection process of subcontractors
  Can 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
Acambis
Accraply
                 VENDOR TEAM FOR SMALLPOX FACILITY
                                   Product Tank
                                   Labeling Machine
                                                                                                 Support
Alban Rentals                      Plant Chillers, Plant Cooling Towers, Plant Boiler
Atlantic Technologies              Sterility Incubators
Baker                              Fume hoods for lab
Bocsh
      Selection process of subcontractors
BTH Company
Bushong Industrials
                                   Vial Filler, Trayloader, Transfer Conveyor
                                   Biowaste Deactivation Tank, Biowaste Sump Tank, WFI Pump, WFI Heat Exchanger
                                   Polyproylene Sump

              Can you devote 3 months, 24/7 to this project?
Camfil Farr                        Exhaust Filters & Frames, ULPA Filters & Housings
Climate Technologies               -20 C Freezers, 2-8 C Cold Rooms, 35 C Warm Room
Climet Technologies                Portable Particle Counter System
Continential Equip,                Non-Equipment Decon Autoclave
              How many workers can you have here tomorrow?
Dan Rainville & Assoc.
DS Pipe & Supply
                                   Air Handling Units, Humdifier, VFD’s for AHU and Exhaust Fans, Steam Valves
                                   Piping Materials
Engineered Piping Products         Process Piping Materials
Ferguson’s
Fluid Flow
              Construction done - 1/15/02
                                   UG & Process Piping Material
                                   WFI & Biowaste Filters & Housing
FP Development                     Inspection Stations, Bidirectional Tables, Accumulating Conveyor, Inkjet Marking

Garvey
Genesis
         Are you up to the challenge?
                                   System, Thru-Wall Conveyor, Trayloader, Turntables
                                   Vial Washer
                                   Westcapper
Getinge                            Equipment Decon Autoclave

      Selection process of Vendors
James M. Pleasants Co.             Recirculating Pumps
Kaestner Company                   Stainless Steel Fittings
L.M. Pond                          Dampers & Louvers
Matheson Tri-Gas                   Nitrogen Manifold
Mueller
              How fast can you have the equipment here?
Pakon Engineering Products
                                   Pure Steam Generator
                                   WFI Pipe, PBM Valves, Steam Traps
PBM                                Valves
              Need best quality with best delivery date
Twin City Fan & Blower
Sentinel
                                   Exhaust Fan
                                   Diaphragm Valves
Swagelok – Balt. Valve & Fitting   Valves & Fittings
Tencarva Machinery Co.             Air Compressor, Air Dryer, Air Receiver
TFC/Filtrex                        Bag In & Bag Out Filter & Housing
Trane Co.                          Rooftop Unit
Tri-State Techinical Sales         Valves & Fittings
Veltek Associates                  SMA System
                                      Support
Selection process of subcontractors
  Can 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 subcontractors
  Can 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
                            Daily Routine
Meetings
  Daily meetings with owner & design team
  Contractor team meetings in late evening
  Coordination meetings every day
Shifts
  Worked 7 days a week
  Two 10-12 hour shifts daily
                            Daily Routine
Meetings
  Daily meetings with owner & design team
  Contractor team meetings in late evening
  Coordination meetings every day
Shifts
  Worked 7 days a week
  Two 10-12 hour shifts daily
                             Construction
Fabrication/Warehouse
  Fabrication of steel on site
  Fabrication of piping systems on site
  55K SF bldg. to store material & equipment
How did it work?
  Team dedication
  Confidence
  Coordination of all parties involved
  Cooperation of City of Baltimore, BGE, & BDC
                             Construction
Fabrication/Warehouse
  Fabrication of steel on site
  Fabrication of piping systems on site
  55K SF bldg. to store material & equipment
How did it work?
  Team dedication
  Confidence
  Coordination of all parties involved
  Cooperation of City of Baltimore, BGE, & BDC
                             Construction
Fabrication/Warehouse
  Fabrication of steel on site
  Fabrication of piping systems on site
  55K SF bldg. to store material & equipment
How did it work?
  Team dedication
  Confidence
  Coordination of all parties involved
  Cooperation of City of Baltimore, BGE, & BDC
                             Construction
Fabrication/Warehouse
  Fabrication of steel on site
  Fabrication of piping systems on site
  55K SF bldg. to store material & equipment
How did it work?
  Team dedication
  Confidence
  Coordination of all parties involved
  Cooperation of City of Baltimore, BGE, & BDC
                             Construction
Fabrication/Warehouse
  Fabrication of steel on site
  Fabrication of piping systems on site
  55K SF bldg. to store material & equipment
How did it work?
  Team dedication
  Confidence
  Coordination of all parties involved
  Cooperation of City of Baltimore, BGE, & BDC
                                        Timeline
11-1-01: Notice to Proceed
11-5-01: Programming & Conceptual Design
11-6-01: Expand Seaboards Bldg. for Utilities
11-7-01: Start Construction
11-8-01: Procurement of HVAC
11-15-01: Procurement of Mfg. Equipment
11-19-01: Complete Production Area Steel
12-3-01: Begin Temp. Plant Utilities Installation
12-20-01: Start Lab Design
12-21-01: Start Lab Construction
12-27-01: Utility Start Up
1-11-02: HVAC System Operational
1-15-02: Substantially Complete
                                                                                     Timeline




          11-5-01                                                       12-20-01
11-1-01             11-7-01   11-8-01   11-15-01   11-19-01   12-3-01              12-27-01   1-11-02   1-15-02
          11-6-01                                                       12-21-02
                    Technical Hurdles
Existing Shell Dimensions
  Added utility building
  Added lab space
  Equipment spaces tight
Learning Curve
Multiple Changes in Process Equipment
  Three different fillers
  VHP with isolator was in then out
  Many changes due to availability
No Product Specifications
                    Technical Hurdles
Existing Shell Dimensions
  Added utility building
  Added lab space
  Equipment spaces tight
Learning Curve
Multiple Changes in Process Equipment
  Three different fillers
  VHP with isolator was in then out
  Many changes due to availability
No Product Specifications
                     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
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
                     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 process
  Generate more meeting minutes
  Use small redundant utility systems
  Clear definition of product supply chain
                       Lessons Learned
What we did right:
  Direct hires
  Constant communication
  Catered lunch onsite
  Hired the right level of experienced people
  Draw from the expertise of ISPE
  Right size organizations
  Made FDA & CDC comfortable with the process
  Installed a wireless network onsite for web & email
  On site design team & office

				
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