Implementation of PAT Key elements for success.

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Christine Fox
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1 Implementation of PAT Key elements for success. Dr. Kjell FRANCOIS PAT consultant PAT Event, Frankfurt, October 6 th

2 How to implement a PAT enabled framework? Page 2 Can you still see the forest through the trees?

3 How to implement a PAT enabled framework? Page 3 What data are you interested in? Which Unit Ops Process data Analyzer data Offline results? What metadata and identifiers are needed? Batch numbers DoE identifiers Material ID s How to integrate PAT into your existing SCADA/Batch or DCS infrastructure? How to go for an optimized process control and real time product release? How to Validate your PAT framework? How to share your findings with your colleagues? How to translate your data into knowledge? How to align all PAT related data? Process data Analyzer data Offline results?

How to implement a PAT enabled framework? Page 4 What data are you interested in? Which Unit Ops Process data Analyzer data Offline results? What metadata and identifiers are needed?

4 How to implement a PAT enabled framework? Page 4 What data are you interested in? Which Unit Ops Process data Analyzer data Offline results? What metadata and identifiers are needed? Batch numbers DoE identifiers Material ID s How to integrate PAT into your existing SCADA/Batch or DCS infrastructure? How to go for an optimised proces control and real time product realease? How to Validate your PAT framework? How to share your findings with your colleagues? How to translate your data into knowledge? How to align all PAT related data? Process data Analyzer data Offline results?

5 How to get the data you need? Integrated data collection PAT software layer communicates with the analyzers and the process Instrument drivers controlling your analyzers Enable calibrations & performance qualifications via workflows One layer fits all Data alignment Different data collection rates Sometimes synchronous (e.g. granulation) sometimes asynchronous (e.g. blending) Integration of off-line data? Integration of raw material data? Real time modeling Do real time calculations based on all available PAT data Perfect analyzer integration is critical Saving time Data integrity Calibration models, Characterization/Identification models, Batch quality models Page 5

6 PAT data management Pressure Temp RM Attribute 1 Speed Quantitative result NIR PSD RM Attribute 2 Raman Qualitative result SIPAT brings all data (in-line, at-line, on-line and off-line) in relation Page 6

7 PAT data management Analyzer data Process data Context & Info data SIPAT Runtime data Real time calculations Raw material data Off line results LIMS data Page 7

8 PAT data management SIPAT External application Meta & context Data data Knowledge Analyzer Data ( NIR, Raman, PSD, ) Process Data Predicted data Off- line lab data (RM,process samples, ) Other data - Batch number -Trial number - Process step - Product -Campaign. Create Model Page 8

9 Model creation Turning data into knowledge Process understanding Base of QbD Model Builder Integrate all relevant PAT data Send to Chemometrics application Simca QP+ Matlab Camo - Unscrambler Create Model Page 9

10 Model creation Next level Advanced process control Use knowledge to close the control loop Transfer data from PAT application to control layers Siemens PCS7 Batch S7 Integration PharmaMV (Perceptive Engineering) Open communication Next level Real time release Result of QbD Page 10

11 Knowledge sharing We developed an optimized method for granulation We have an outstanding blending model for product X We have optimized our data collection strategy for tableting Page 11

12 Knowledge sharing Different locations worldwide have the same needs Share PAT knowledge Analyzers configurations & setting Data collection strategies Alignment strategies Predictive & descriptive models Centralized data Think global Act local! Page 12

13 PAT into Integration of PAT into SCADA/Batch/DCS Seamless integration of PAT application in Automation layer Automated start/stop of data collection Follow the phases of your recipes Share alarms Send data from the PAT layer to the automation layer PAT should not be a blocking issue, but should make your process more lean. Page 13

14 PAT into Integration of PAT into SCADA/Batch/DCS Screen of classic GUI Operator screen PCS7 screen Still to be added Page 14

15 PAT into Integration of PAT into SCADA/Batch/DCS Screen of classic GUI Operator screen PCS7 screen Still to be added Page 15

16 PAT into Integration of PAT into SCADA/Batch/DCS Screen of classic GUI Operator screen PCS7 screen Still to be added Page 16

17 PAT Project validation URS RTM FS FAT, SAT, tests SDS Unit tests Risk based approach realization Configuration Management Project management Page 17 QA

18 PAT Project validation Scalable validation approach of Core PAT database & software New analyzers = plug in approach Roll-outs = risk based approach Upgrades = risk based approach Repeatable validation approach Page 18

19 Highlights Data collection is key Turn data into knowledge QbD Think global, Act local Seamless integration of PAT into Integrated validation Page 19

20 Thank you for your attention! Dr. ir. Kjell FRANCOIS SIPAT Business Area Manager Siemens I IS IT Halsesteenweg Ninove Phone: Fax: Mobile: Kjell.Francois@siemens.com

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