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Design/Build of a Smallpox Vaccine Facility

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

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Design/Build of a Smallpox Vaccine Facility

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  1. Design/Build of a Smallpox Vaccine Facility BL2/3 Fill Finish O’NEAL, Inc CBL WHITING-TURNER

  2. 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

  3. Background Briefing • Proposal to combat bio-terrorism • Contract competition • Acambis, Baxter, CBL Team • CBL Already has capital expansion plans

  4. 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

  5. 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

  6. 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

  7. The Beginning • The Concept becomes the Goal • The Challenge: Begin manufacturing the vaccine by 2/15/02 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

  8. 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

  9. 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

  10. First Things First • Assembled Team • Whiting-Turner • O’Neal Design & Engineering • CBL Management • Hand picked subcontractors • Hand picked vendors

  11. Subcontractors Vendors

  12. 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

  13. 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

  14. 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, Michael Architect 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

  15. Subcontractors Vendors

  16. Support SUBCONTRACTOR TEAM FOR SMALLPOX FACILITY Concrete Work Whiting-Turner Masonry Banner Masonry Steel Fabricators Whiting-Turner Steel Erectors Whiting-Turner Misc. Stainless Steel Warren Ehret Company Carpentry Whiting-Turner Roofing Warren Ehret Company Caulking & Waterproofing M.N.P. Waterproofing Door/Frame/Hardware (Furn) Custom Engineered Openings Door/Frame/Hard (Install) Centerline Construction Door Controls ARK Controls Drywall & Ceiling Centerline Construction Painting Paras Painting Epoxy Flooring Stonhard Sheet Vinyl Flooring Specialty Interior Construction Lab Casework VWR International Sheetmetal/Ductwork Supply – Galvanized Warren Ehret Company xhaust – Stainless Steel Stromberg Metal Works Building Mgmt. System Siemens Mechanical/Plumbing Whiting-Turner Process Piping Whiting-Turner Duct/Pipe Insulation 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 • 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

  17. 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

  18. Support • VENDOR TEAM FOR SMALLPOX FACILITY • Acambis Product Tank • Accraply Labeling Machine • Alban Rentals Plant Chillers, Plant Cooling Towers, Plant Boiler • Atlantic Technologies Sterility Incubators • Baker Fume hoods for lab • Bocsh Vial Filler, Trayloader, Transfer Conveyor • BTH Company Biowaste Deactivation Tank, Biowaste Sump Tank, WFI Pump, WFI Heat Exchanger • Bushong Industrials Polyproylene Sump • 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 • Dan Rainville & Assoc. Air Handling Units, Humdifier, VFD’s for AHU and Exhaust Fans, Steam Valves • DS Pipe & Supply Piping Materials • Engineered Piping Products Process Piping Materials • Ferguson’s UG & Process Piping Material • Fluid Flow WFI & Biowaste Filters & Housing • FP Development Inspection Stations, Bidirectional Tables, Accumulating Conveyor, Inkjet Marking System, Thru-Wall Conveyor, Trayloader, Turntables • Garvey Vial Washer • Genesis Westcapper • Getinge Equipment Decon Autoclave • James M. Pleasants Co. Recirculating Pumps • Kaestner Company Stainless Steel Fittings • L.M. Pond Dampers & Louvers • Matheson Tri-Gas Nitrogen Manifold • Mueller Pure Steam Generator • Pakon Engineering Products WFI Pipe, PBM Valves, Steam Traps • PBM Valves • Twin City Fan & Blower Exhaust Fan • Sentinel 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 • 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. Timeline 11-1-01 11-5-01 11-6-01 11-7-01 11-8-01 11-15-01 11-19-01 12-3-01 12-20-01 12-21-02 12-27-01 1-11-02 1-15-02

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. New Equipment • FAT/SAT • Distance from site • Training • Not in control of production • Higher first cost

  36. 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

  37. 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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