Microsoft PowerPoint - ISPE Nordic PAT architectures
20070529.pptPage 2 29/05/2007
Design of a PAT infrastructure
PAT for manufacturing How a PAT architecture can improve
operational excellence PAT System design Data capturing and
analysis Analyzer management Data storage & retrieval
PAT for development PAT as a continuous process understanding
improvement tool Process Knowledge Hierarchy Future
developments
Conclusions
Actual & future manufacturing requirements
Manufacturing accounts for the second highest cost factor Research
driven pharma companies 31% Generic manufacturers 51% Contract
manufacturers 62%
Source: St Gallen report, 2006
How will companies cope with changing environment? What is the
strategic response?
Changes due to new production technologies Increase operating
efficiency Reduce product costs / achieve competitive pricing
Produce individual products / address niche markets
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Process Analytics
Risk-based inspection regimes
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Input from one or more analytical instruments and process
variables
Used to predict
High Level Enables optimization of the complete process
Gathers data from all Process steps via PAT Base Stations
Allows to follow up total batch quality and compare with process
specifications
Enables Real Time Product Release
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Analyser Laser Sizer
VisualizationsVisualizations
Multiple Model Levels
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Integrated Data Portal
PAT measurements & predictions
Batch Context & Metadata
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How PAT can close the gap between development and
manufacturing
PAT as a continuous process understanding & improvement
tool
PAT as part of the knowledge hierarchy
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Quality systems approach (Develop a quality system which reflects
product & process understanding and knowledge)
Should be integrated in process development
Even more so linked to clinical trials (development of quality
surrogates for clinical performance)
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Data Mining tools
Develop the future vision for the manufacturing and development
infrastructure / architecture
Knowledge management tools will play a prominent role
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Thank you very much for your attention.
Contact Johan Ronsyn Siemens nv Production & Quality Management
Tel : +32 54 312 720
[email protected]
www.siemens.com/SIPAT
