critical steps in process design michel gigon, associate, laporte consultants september 28, 2006
TRANSCRIPT
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Critical Steps in Process Design
Michel Gigon, Associate, Laporte Consultants September 28, 2006
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Agenda
Definitions and General Considerations
Critical Steps in Process Design
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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.
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Process Design in the pharmaceutical industry
Process Design versus Product Life Cycle
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Discovery
Biological Tests
Phase I
Phase II
Phase III NDA
Launch & Commercial production
PRODUCT DEVELOPMENT
-20 0 2 4 6 8 10
YEARS
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Discovery
Biological Tests
Phase I
Phase II
Phase III NDA
Launch & Commercial production
Process Research (1 gr – 1 kg)
PRODUCT DEVELOPMENT
PROCESS DEVELOPMENT
-20 0 2 4 6 8 10
YEARS
Commercial Plant Transfer (100 kg- tons)
Pilot Development (1 kg-100 kg)
Optimisation, Capacity Increase
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Discovery
Biological Tests
Phase I
Phase II
Phase III NDA
Launch & Commercial production
Process Research (1 gr – 1 kg)
Pilot Plant Operation
First Plant Operation
Laboratory – Research Laboratory –
Development
PRODUCT DEVELOPMENT
PROCESS DEVELOPMENT
FACILITY AND EQUIPMENT
-20 0 2 4 6 8 10
YEARS
Commercial Plant Transfer (100 kg- tons)
Pilot Development (1 kg-100 kg)
Plant Operation
Optimisation, Capacity Increase
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Discovery
Biological Tests
Phase I
Phase II
Phase III NDA
Launch & Commercial production
Process Research (1 gr – 1 kg)
Pilot Plant Operation
First Plant Operation
Laboratory – Research Laboratory –
Development
PRODUCT DEVELOPMENT
PROCESS DEVELOPMENT
FACILITY AND EQUIPMENT
Design, Build, Validate
Design, Build, Validate
-20 0 2 4 6 8 10
YEARS
Commercial Plant Transfer (100 kg- tons)
Pilot Development (1 kg-100 kg)
Design, Build, Validate
Subsequent Plant Operation
Optimisation, Capacity Increase
PROCESS DESIGN
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The four pivots of process design
Process
Pharmaceutical Process
Science
Mechanical Automation
Validation
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Project Life Cycle
Conceptual
Design
PreliminaryDesign
DetailedDesign
Equipment Manufacturing
Construction
Validation
Support
FAT
Start-Up
SAT
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Definition of the user requirements• Process
• Production capacity
• Product specification
• Development phase of the product
Conceptual design
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Conceptual design
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
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Conceptual design
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 (%)
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Conceptual design
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….
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Conceptual design
Definition of the user requirements• Production capacity
• ….
• Equipment utilisation (%)
• Pilot plant : 20-50%
• First commercial plant : 70% max
• Mature process : > 80%
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Definition of the user requirements• Product specification
• Sterility
• Water quality
• Concentration
• Impurity levels
Conceptual design
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Definition of the user requirements
• Development phase of the product
Conceptual designFle
xib
ilit
y
Process maturity
Laboratory
Pilot plant
First PlantSubsequentplant
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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
Conceptual design
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Preliminary design
Facility definition and sizing• Preliminary specifications of the process equipment
• Sizing of utilities
• Sizing of spaces
• Preliminary specifications of the automation system
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Preliminary design
Facility definition and sizing• Preliminary specification of the process equipment
• Volume, capacity
• Material
• Functionality
• Process paramaters
• Design and operation range (pressure, temperature, etc…)
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Preliminary design
Facility definition and sizing• Sizing of utilities and spaces
Process equipment
Process supportCIP, solution prep…
Process Utilitieswater, effluent treatment…
Spacesproduction, mechanical rooms, warehouse…
Building utilitiesHVAC, Steam, chilled water, power…
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Preliminary design
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
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Preliminary design
Facility definition and sizing Risks
• Inadequate process equipment
• Insufficient space and utilities
• Inadequate control and automation
• => Production capacity cannot be met
• => Difficulties of operation
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Detailed design
Detailed specification of all components of the installation
• Mechanical components
• Fabrication specification
• Installation specification
• Automation
• Hardware
• Software
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Detailed design
P&ID
Components List
Mechanical components specification
Installation drawing (3D, isometrics)
I/O List
Automation components specifications
Sequences of operation
Alarms Interlocks
Access rights
Control panel drawings loop diagram
wiring diagramProgramming
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Detailed design
Detailed specification of all components of the installation
Risks• Inappropriate installation
• Cleaning and sterilisation issues
• Corrosion issues
• Operational difficulties
• Maintenance difficulties
• Accessibility issues
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Construction and Fabrication
Construction follow-up Documentation follow-up Start-up and testing (FAT, SAT)
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Construction and Fabrication
Construction follow-up• Ergonomy and accessibility
• Slopes
• Dead legs
• Weld quality
• Etc…
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Construction and Fabrication
Documentation follow-up
Update of design document
(P&ID, specifications)
Data SheetsIsometrics
Test Certificates
Turn-Over Package
Validation Maintenance
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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
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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
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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
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Questions ?