Advancements in Modularization

Transcription

1 Advancements in Modularization Standardization, Modular Unit Operations and Global Deployment Interphex 2013 New York, NY Pär Almhem President ModWave & ModularPartners

2 Outline Introduction to Modularization Lessons Learned Developing the Modular Concept Summary and Outlook

3 IntroductiontoModularization

4 Historic View of Modularization

5 Our View of Modularization

6 Shorter Schedule Months Shorter than Conventional Methods Cost and Schedule Certainty Proven Designs ModularAdvantages Standardized, Pre-Engineered Modular Solutions Ability to Deliver Complete Products and Services Clean Manufacturing Environment 75-80% of Project in Supplier s Factory Higher Safety and Less Waste High Quality Design and Fabrication Buildings and Skids are Manufactured Not Constructed Personnel Trained on a Large Number of Highly Technical Projects Responsibility from Design Through Startup & Testing

7 Experience Pharma Examples Merck, Durham, NC Merck, Carlow, Ireland Biogen Idec, RTP, NC Bristol-Meyers Squibb Syracuse, NY Genentech, South San Francisco, CA Eisai, RTP, NC.

8 Module Manufacturing Lean assembly line type production OUT IN

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10 Complete Filling Line Integrated in Modules

11 Complete Unit Operation In one Vertical Module: IBC Hoist/Blender, Granulator, FBD and Mill/Sieve with support Areas Allows for Standardization, Pre-Testing, Schedule Reduction 3D Model

12 Lessons Learned and Further Development

13 ModularConstruction Benchmark 70% of all modular projects completed with 3% or less cost variance 90% less than 10% 4 times better than Industry Best Practice 80% of all modular projects completed within 2 months of initially contracted schedule 5 times better than Industry Best Practice

14 LessonsLearned Team Building and Design Alignment Critical Significant Changes can be Incorporated Module Manufacturing a Well-Oiled Machine Interaction With Process Equipment Suppliers can be Improved Site Assembly and Start-Up can be Improved

15 Further Development Improve Project & Site Management, Interaction With Equipment Suppliers Lean Approach to Design and Manufacturing Refining the Modular Concept Standardization Modular Unit Operations Wider Range of Modular Solutions

16 Developing the Modular Concept

17 Modularization Considerations Process Functions Design to minimize work on site Phasing Transportation Standardization

18 Modularization -Example 1. Each system will be analyzed and the process functions modularized 2. Modularized functions displayed in adjacency diagram Process modules and support modules creates a functional layout Mixing Module Separation Module Phasing Scope 3. Adjacency diagram developed to an architectural layout. Grid system to support both modular and conventional building One building module can consist of several process modules Process modules can easily be changed to other technology or unit operation in future Construction can be phased in time to match increased capacity requirements

19 Types of Modules Modular Facility as free-standing building façade and roofing including Foundation typically a concrete slab with piers to create space for drain/waste pipes etc. Can placed on top of or next to an existing building Indoor module for placement in existing building Indoor modules to be placed on concrete slab Pipe racks on top of or below modules Piers to create space for drains, pipe racks etc HVAC to be placed on top of or beside modules Process skids and other pre-assemblies

20 Solutions for Manufacturing ofthe Future Design and Build Standardized, Pre-engineered Modular Solutions that can be Configured, Combined and Repeated for Future Use Create Products and Solutions that can be Rapidly Configured and Deployed Globally Move from Customization to Configuration Minimize Cost by Minimizing Need for Re-engineering Maximize Flexibility by Allowing for Configuration

21 StandardizedDesigns Global Standard Design Solution Ca 10 % Site Specific Ca 75 % Global Standard Design Solution Ca 15 % Customization

22 Standard Solutions Process/ Unit Operations Equipment with Support Functions Complete in a Module Complete Facilities Fill & Finish OSD Cell Culture Standard Layouts Capacity From Pilot Plant to Production Scale Fast Delivery Time 6-12 Month from Order to IQ/OQ Can be Stand-Alone, Docked to Warehouse, Spine etc., or Installed in an Existing Warehouse or Similar

23 Modular Lab

24 Modular Fill Suite Isolator Version RABS Version

25 ModularWeighand Dispense Suite

26 ModularWeighand DispenseSuite

27 Operating Cost Comparison for Single-Use vs. Stainless Steel Facilities Production of monoclonal antibodies using a standard platform process Process modeling courtesy of BioProcess Technology Consultants, Inc. Operating Costs Stainless Steel Facility Single-Use Facility Annual Batch Annual Batch Quantity of Product Produced 105 Kg 7 Kg 105 Kg 7 Kg Materials $607,428 $40,495 $590,334 $39,356 Consumables $3,611,689 $240,779 $4,268,890 $284,593 Labor (Direct/Indirect) $17,133,065 $1,142,204 $12,011,414 $800,761 Maintenance/Utilities/Waste $2,268,686 $151,246 $1,454,109 $96,941 Total $23,620,868 $1,574,725 $18,324,748 $1,221,650 Operating Costs Per Gram $225/gram $175/gram

28 ModularmAbFacility Air Lock Air Lock Locker Final Purification and bulk filling Cell Cultivation and Purification Locker Media and Buffer Preparation Media and Buffer Hold Dispensing Raw Material storage Consumables storage Equipment Storage Washing Seed Lab Air Lock

29 Design Philosophy Layout Area Divided into 6 Functional Modules: 1. Material Staging and Dispensing 2. Media and Buffer Prep/Hold 3. Cell Cultivation (including seed lab) and Purification 4. Final Purification 5. Support Areas 6. Air Locks and Corridors Final Purif. Material Staging and Dispensing Airlocks and Corridors Cell Cultivation and Purification Media and Buffer Prep/Hold Support areas

30 Unit Operations / CompleteProcess Solutions Complete solution Process solution Modular solution Process planning for a multi-purpose facility for a pharmaceutical OSD manufacturing plant

31 Unit Operations / CompleteProcess Solutions Dosing / Feeding Mixing / Processing Dosing / Filling

32 Complete Continuous Tabletting Line

33 Complete Continuous Tabletting Line

34 A New Generation Modular Facilities

35 Foundation Concrete Foundation

36 FirstFloorModules Pre-installed Ductwork. Piping & Electrical Utility Ceiling Panel Pre-installed Equipment

37 Second FloorPerimeter Modules Electrical Room Inside Modules Roof Supported from Second Floor Modules

38 Mezzanine Pre-fabricated Ductworks Pre-fabricated AHU-Skids Pre-fabricated Pipe Racks

39 FirstFloorModules

40 Second FloorPerimeter Modules

41 Mezzanine Extended Ceiling Height

42 Pre-Fabricated Installations

43 Pre-FabrictedRoofSystem

44 Summary and Outlook

45 Summary Modular Has Become a Buzzword Very few have the experience and resources to execute Modularization Has Proven To Be Beneficial in Many Applications The Modular Concept is Rapidly Developing and Advancing Modules and Skids for unit operations Standardized Solutions Lower cost Modularization is a Broad Concept Make Sure to Understand What it Means to You Choose the Right Partner and Work Together From the Start

46 Outlook Most Processes and Process Facilities will be Modular Extensive Use of Modular in Emerging Markets Lower Cost, Shorter Schedule, Same Quality Applications for Renovations and Upgrades Standardization Modular Unit Operations

47 Questions & Discussion