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Critical Steps in Process Design

Critical Steps in Process Design. Michel Gigon, Associate, Laporte Consultants September 28, 2006. Agenda. Definitions and General Considerations Critical Steps in Process Design. Definitions. Product Development  : Creation of a new product

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Critical Steps in Process Design

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  1. Critical Steps in Process Design Michel Gigon, Associate, Laporte Consultants September 28, 2006

  2. Agenda • Definitions and General Considerations • Critical Steps in Process Design

  3. Definitions • Product Development : Creation of a new product • Process Development : Development of a production method (recipe) • Process Design : Design of the equipment required for the production of a product, according to a pre-determined process.

  4. Process Design in the pharmaceutical industry • Process Design versus Product Life Cycle

  5. PRODUCT DEVELOPMENT Discovery Phase I Phase II Phase III NDA Launch & Commercial production Biological Tests -20 0 2 4 6 8 10 YEARS

  6. PRODUCT DEVELOPMENT Discovery Phase I Phase II Phase III NDA Launch & Commercial production Biological Tests PROCESS DEVELOPMENT Process Research (1 gr – 1 kg) Pilot Development (1 kg-100 kg) Commercial Plant Transfer (100 kg- tons) Optimisation, Capacity Increase -20 0 2 4 6 8 10 YEARS

  7. PRODUCT DEVELOPMENT Discovery Phase I Phase II Phase III NDA Launch & Commercial production Biological Tests PROCESS DEVELOPMENT Process Research (1 gr – 1 kg) Pilot Development (1 kg-100 kg) Commercial Plant Transfer (100 kg- tons) Optimisation, Capacity Increase FACILITY AND EQUIPMENT Laboratory – Research Laboratory – Development Pilot Plant Operation First Plant Operation Plant Operation -20 0 2 4 6 8 10 YEARS

  8. PRODUCT DEVELOPMENT Discovery Phase I Phase II Phase III NDA Launch & Commercial production Biological Tests PROCESS DEVELOPMENT Process Research (1 gr – 1 kg) Pilot Development (1 kg-100 kg) Commercial Plant Transfer (100 kg- tons) Optimisation, Capacity Increase FACILITY AND EQUIPMENT Laboratory – Research Laboratory – Development Design, Build, Validate Pilot Plant Operation Design, Build, Validate First Plant Operation Design, Build, Validate Subsequent Plant Operation PROCESS DESIGN -20 0 2 4 6 8 10 YEARS

  9. The four pivots of process design Mechanical Automation Science Process Validation Pharmaceutical Process

  10. Conceptual Design Preliminary Design Detailed Design Start-Up SAT Construction Equipment Manufacturing FAT Validation Support Project Life Cycle

  11. Conceptualdesign • Definition of the user requirements • Process • Production capacity • Product specification • Development phase of the product

  12. Conceptualdesign • Definition of the user requirements • Process • Pilot plant : unit operations, lab procedure example • First commercial plant : lab method, preliminary results from pilot plant • Subsequent facility : existing process

  13. Conceptualdesign • Definition of the user requirements • Production capacity • Requirements (kg/year, units/year) • Batch size (kg/batch, units/lot) • Titre (kg/L) • Production time (days/lot) • Production schedule (24/7, 8/5) • Operation (by campaign, by lots) • Production opening (weeks/year) • Losses (%) • Equipment utilisation (%)

  14. Conceptualdesign • Definition of the user requirements • Production capacity • Requirements (kg/year, units/year) • Batch size (kg/batch, units/lot) • Titre (kg/L) • Production time (days/lot) • Set-up, production process, cleaning, sterilisation, testing, product change-over….

  15. Conceptualdesign • Definition of the user requirements • Production capacity • …. • Equipment utilisation (%) • Pilot plant : 20-50% • First commercial plant : 70% max • Mature process : > 80%

  16. Conceptualdesign • Definition of the user requirements • Product specification • Sterility • Water quality • Concentration • Impurity levels

  17. Laboratory Flexibility Pilot plant First Plant Subsequentplant Process maturity Conceptualdesign • Definition of the user requirements • Development phase of the product

  18. Conceptualdesign • Definition of the user requirements • Process • Production capacity • Product specification • Development phase of the product • Risks • Inability to manufacture the product • Inadequate plant capacity • Lower quality product • Inappropriate flexibility

  19. Preliminarydesign • Facility definition and sizing • Preliminary specifications of the process equipment • Sizing of utilities • Sizing of spaces • Preliminary specifications of the automation system

  20. Preliminarydesign • Facility definition and sizing • Preliminary specification of the process equipment • Volume, capacity • Material • Functionality • Process paramaters • Design and operation range (pressure, temperature, etc…)

  21. Preliminarydesign • Facility definition and sizing • Sizing of utilities and spaces Process equipment Spacesproduction, mechanical rooms, warehouse… Process supportCIP, solution prep… Building utilitiesHVAC, Steam, chilled water, power… Process Utilitieswater, effluent treatment…

  22. Preliminarydesign • Facility definition and sizing • Preliminary specification of the automation system • Manual vs automated operation • Transfer panel vs manifold… • Level of automation • Local controller, unit operation control, batching, archiving • General architecture

  23. Preliminarydesign • Facility definition and sizing • Risks • Inadequate process equipment • Insufficient space and utilities • Inadequate control and automation • => Production capacity cannot be met • => Difficulties of operation

  24. Detaileddesign • Detailed specification of all components of the installation • Mechanical components • Fabrication specification • Installation specification • Automation • Hardware • Software

  25. Detailed design P&ID Sequences of operation I/O List Components List Alarms InterlocksAccess rights Automation components specifications Mechanical components specification Control panel drawings loop diagram wiring diagram Installation drawing (3D, isometrics) Programming

  26. Detaileddesign • Detailed specification of all components of the installation • Risks • Inappropriate installation • Cleaning and sterilisation issues • Corrosion issues • Operational difficulties • Maintenance difficulties • Accessibility issues

  27. Construction and Fabrication • Construction follow-up • Documentation follow-up • Start-up and testing (FAT, SAT)

  28. Construction and Fabrication • Construction follow-up • Ergonomy and accessibility • Slopes • Dead legs • Weld quality • Etc…

  29. Construction and Fabrication • Documentation follow-up Update of design document (P&ID, specifications) Data SheetsIsometricsTest Certificates Turn-Over Package Maintenance Validation

  30. Construction and Fabrication • Start-up and testing • Verification of the quality of fabrication • Verification of all design hypothesis • Control of process parameters • Process sequences are achievable • Equipment drainable, cleanable and sterilisable

  31. Construction and Fabrication • Construction follow-up • Documentation follow-up • Start-up and testing (FAT, SAT) • Risks • Inadequate installation • Cleaning and contamination issues • Ergonomic and operational issues • Inadequate documentation • Validation issues • Maintenance issues

  32. Validation • Adequate documentation facilitates protocol preparation and execution • Review of validation criterion can avoid unnecessary deviation • Participation in protocol execution facilitates and accelerates protocol execution

  33. Questions ?

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