Providing a Single Point for Accessing and Reporting Historical and Batch Data

1. Providing a Single Point for Accessing and Reporting Historical and Batch Data Jeffrey Leverton Controls Engineer Diosynth a Part ofScheringPlough

2. The Challenge: Single data historian and reporting tool for multiple systems. “We use the PI system internally to provide a single point to access batch and historical data from our ABB, Allen Bradley, Siemens and G.E. platforms” Customer Results / Benefits Customer Business Challenge Solution • Without the PI system it would take approximately 10 minutes per day per tag to retrieve the same data • Comparing batch runs allow us to anticipate, recognize and correct problems that may arise • Independent of the control system we always have the requirement to provide consistent data collection and reporting • Provide quick data retrieval for our legacy ABB MOD 300 DCS • Provide a means for Batch comparison of campaign Batches • Integrate and provide a means of reporting for our Siemens, Allen Bradley and G.E. systems • Leverage our PI system to provide a means or retrieving data from our Unix based ABB MOD 300 DCS • Using Batch View we can compare different batch runs from the same campaign • Based on client needs we have the requirement to support specialized equipment

3. Diosynth a part of Schering Plough Custom Manufacturing of Biopharmaceuticals Size: 140,000sq ft Employees: ~500 Technology: Mammalian and Insect Cells Cell Culture Bacteria and Yeast Fermentation

4. Facility Design CELL CULTURE (Mammalian and Insect Cells) • Two cell culture inoculum preparation suites with 20 L seed bioreactors • Dedicated small-scale production areas with two x 110 L bioreactors • Intermediate-scale production train: - 150, 650 and 2,000 L production cell culture bioreactor train • Dedicated buffer and media preparation areas

5. Facility Design FERMENTATION (Bacteria and Yeast) • Two inoculum preparation suites with 30 L seed fermentors • Dedicated small-scale production areas with two x 140 L fermentors • Two separate intermediate-scale suites: - One 150 L and 3 x 2,000 L production fermentors • Capability to process high density cultures with high cooling demands • In-line mass spec gas analysis process control

6. Facility Design FERMENTATION - Harvest and Recovery One small-scale & two intermediate-scale recovery suites with: Holding tanks Centrifuges (disc stack, nozzle discharge) Two Homogenizers – up to 1,000 bar Recovery vessels – up to 3,000 L Refold suite

7. Facility Design CELL CULTURE - Harvest and Recovery Dedicated harvest suite 2,000 L harvest vessel Microfiltration equipment – up to 200 ft2 Centrifuges / homogenizers

8. Facility Design PURIFICATION (Cell Culture and Fermentation) • Four Class 100,000 small-scale purification suites • Three Class 10,000 intermediate-scale purification suites • Two solution preparation suites – up to 3,000 L • Chromatography skids – up to 1,000 L/h • Column sizes up to 100 cm diameter

9. Facility Design PURIFICATION (Cell Culture and Fermentation) (Cont) • Full range of chromatographic methods (SEC, IEX, HIC, HCIC, affinity and expanded bed) • Ultrafiltration / diafiltration skids (filter area 5-200 ft2) • Two small-scale and intermediate-scale bulk filling suites with Class 100 areas • Class 10,000 small-scale Final Formulation suite

10. Current Automation Systems The Diosynth facility is divided into three main automation systems ABB MOD 300 Unix Based System Currently controls most of the plant The historians interpolate data after approximately 45 days from tapes for data Batch reports are generated by our in house Batch Reporting System

11. Current Automation Systems ABB 800xA System Currently in the process of upgrading the MOD 300 system to the 800xA system Reporting is accomplished using Crystal Reports

12. Current Automation Systems Miscellaneous control systems G.E. Unicorn systems (chromatography skids), reporting completed by local system Allen Bradley PLC’s (glass washers and autoclaves), reporting by local printer Siemens PLC’s (disposable bioreactors), reporting through ABB 800xA

13. The Problem The historians interpolates data after approximately 45 days from tapes for data This requires to us to retrieve information from tapes This process takes approximately 10 minutes per tag per day

14. The Solution Use the PI system to collect the data from the MOD 300 system This allows us to quickly retrieve data Also by implementing the PI Batch Database and BatchView we are able to quickly retrieve run data

15. Benefit In order to pull a year’s worth of date for a single point it would take us approximately 36 hours to pull the data. It costs approximately $3600 dollars to pull the data. $100 per hour * 36 hours = $3600 It takes us approximately 30 minutes to pull the data from the PI system. Savings = $3550

16. The Problem Identify issues and differences between batch runs in a product campaign

17. The Solution Use Batchview and PI Module Database to compare production runs in our manufacturing system

18. The Solution

19. Benefit The cost of losing a single batch of a product conformance run is almost equal to our the cost of our PI software.

20. The Problem Currently our glass washers and autoclaves print cycle information on thermal and impact printers Thermal printer paper tends to fade over time. Because of this we scan in all cycle information so that we have long term records of our cycles.

21. The Solution Pull the cycle data into our PI system Purchase RtReports and develop cycle reports

22. Benefit It takes us approximately 1 hours to process the print out from a single glass washer cycle. Estimate 5 cycles a day Therefore if we pull the data into PI we can show a saving of almost $500 dollars a day. $100 * 5 hours = $500

23. Technical Benefits Data is “backed up” in a real-time fashion to the PI server Report generation is paperless since RtReports permits saving to PDF Will be able to remove thermal and impact printers on our autoclaves and glass washers Since we are able to compare campaign runs to each other we will be able to minimize the chances of losing a batch We can quickly retrieve process data

24. The Return on Investment The amount of time an engineer requires to retrieve data is 1/10 of the time required to pull data from backup tapes If we can prevent the loss of even a single batch the work and cost put into creating batch overviews will pay for itself By removing the thermal and impact printers from the plant we are reducing the cost of maintaining the printers which can be problematic

25. Solution Challenges Pulling the required information from our glass washers and autoclaves As we add the ability to overlay process development with manufacturing runs we have to align tags from different control systems with each other

26. Next Steps and Future Opportunities Upgrade to high availability PI servers Purchase RtReports and Webparts Add the ability to overlay process development batch runs with manufacturing batch runs Combine our batch reporting systems into a single batch reporting platform using the RtReports

27. Questions?