The PI System Batch/Event Context for Life Sciences, Food and Beverage, and Specialty Chemicals

Transcription

1 The PI System Batch/Event Context for Life Sciences, Food and Beverage, and Specialty Chemicals Presented by Mike Purcell Petter Moree

2 Introducing Petter Moree Started in September 2015 Comes from MKS Umetrics 10 years experience with OSIsoft 17 years experience from Life Science Solutions Training Software Service M.Sc. Chem. Eng. Chemometrics, Statistics. Based in Sweden, work globally in the team of Mike Purcell 2

3 Agenda (Morning) Time Company Speakers Topic 09:00 09:20 OSIsoft Mike Purcell & Petter Moree The PI system Batch/Event Context for Life Science, Food & Beverage and Chemical 09:20 09:50 MSD Salla Diop MSD's Journey with OSIsoft's Enterprise Agreement & Standardizing on a Core PI System Build 09:50 10:00 Transfer time 10:00 10:30 GSK Vaccine Giulio Ripaccioli & Massimo De Franciscio 10:30 11:00 Break GSK Vaccines' Vision of the Integrated Factory: From Process Data to Information Management 11:00 11:30 Michelin Thomas Forest Enhancing Manufacturing Decision-making Process through Real-time KPI 11:30 11:40 Transfer time 11:40 12:10 Janssen Pharmaceutical Axel Wils The Benefits of a Standardized PI System Infrastructure 12:10 14:00 Lunch 3

4 Agenda (Afternoon) Time Company Speakers Topic 14:00 14:30 Baxalta Christian Bugl From Energy Monitoring to an Engineering Management System 14:30 14:40 Transfer time 14:40 15:10 Novartis Antonio Buendia The Factory of the Future Today 15:10 15:40 Break 15:40 16:10 Allnex & SpiraTec Jan De Wilde & Florian Spribille 16:10 16:20 Transfer time Achieving Uniform Global Production Efficiency and Quality with OSIsoft s PI System 16:20 16:50 Sandoz Alexander Haimayer How the PI System Helps Sandoz in Kundl with Regulatory Compliance 16:50 17:15 Wrap Up 18:00 01:00 Offsite Gala Dinner Zofin Palace 4

5 Life Science industry Continuous Improvements Regulated Data driven Access to data Standardization across Enterprise Flexibility 5

6 ICH Q8-Q10 ICH Q10 Pharmaceutical Quality System Knowledge Management Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components. Sources of knowledge include, but are not limited to prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities. 6

7 Business Challenge Huge opportunity Knowledge Hierarchy Wisdom Knowledge Most processes are multi-steps and have many inputs Information Data 7

8 What is Knowledge? Where is Knowledge? Who has Knowledge? Source: Russ Ackoff From Data to Wisdom, Journal of Applied Systems Analysis, Volume 16, 1989 p

9 What is next? Traceability Track & Trace CPV Continuous Process Verification Every batch, Every Lot is a validation batch PPA Process Performance Analysis Understand Sources of variation QbD Quality by Design Establishment of design space and control strategy 9

10 Connecting the dots Decreasing risk Increasing values Gaining knowledge Reducing variation Standardise Quick, simple Less skill More reliable Dashboard Notification Reporting and distribution Investigation processes Analysis: Univariate to multivariate Statistics Re-evaluation of limits R&D integration Progress Best practice Effectiveness Value Quality Simplify Investigations RCA Access to data Tools to view data & trends Tools to analyse trends Report compilation Grow Geographic spread Visibility More roles Spread the benefits Make the information more visible Empower SME & stakeholders 10

11 SCADA / PLC / DCS The AF/EF PI System Is Fully Integrated to the Enterprise ISA S95 Level 4: ERP PI System Level 3: MES Referenced Data Data Access Electronic Work Instructions Real-Time Data Infrastructure Common Data Presentation Layer PI Server PI Data Access PI AF PI EF Downtime Level 2 Batch Level 1 Batch Control Continuous Control Discrete Control Startup Time Series Assets Events Level 0: Equipment 11 11

12 BUSINESS PROCESSES Advanced Visualization Advanced Analytics SAP HANA INDUSTRIAL PROCESSES

13 Information Technology Domain Enterprise Intelligence Business Intelligence Operational Intelligence Operational Technology Domain 2010 s Cloud era Data Infrastructure (Operational Data Model) 2000 s 1990 s 1980 s ERP era (Financial Data Model) Business Data Warehouse Application Outsourcing Commodity Hardware SQL Best of Breed Applications Technology & Organizational Barriers Commodity Equipment Specialized Applications Distributed Control Tiered Applications Vendor Proprietary Control Systems

14 SAP Application & Solutions Architecture Visualization, Analytics, & Business Process Applications Tableau Spotfire Lumira SAP BW SAP Solutions & SAP Solutions & Applications SAP Solutions & Applications Applications Enterprise Analytics and Applications Platform SAP HANA Data Preparation and Integration Layer SAP HANA Enterprise Information Management and Data Provisioning Agent SAP IOT Adapter by OSIsoft PI Integrator for Business Analytics SAP & Partner Suite of Data Management Tools Systems of Record PI Server CRM Sales EAM ERP HR 14

15 AF & EF Synchronization: Transfer and Aggregate real-time information in context Bottom-Up Approach Sites Publish, Corporate Subscribes Internet 15

16 Contact Information Mike Purcell Director Industry OSIsoft Petter Moree Industry Principal OSIsoft 16

17 Questions Please wait for the microphone before asking your questions Please don t forget to Complete the Online Survey for this session State your name & company 17

18 Thank You