«Digital transformation of Pharma and API Plants: a way to create value for long term sustainability» G. Burba

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«Digital transformation of Pharma and API Plants: a way to create value for long term sustainability» G. Burba Chemistry 4.0 Milan, September 27 th, 2018 1

The 4 th industrial revolution More than 100 yrs Around 70 yrs Around 40 yrs End of 18 century MECHANICAL ASSISTANCE Beginning of 20 century MASS PRODUCTION & ASSEMBLY LINE 1970s ELECTRONICS & CONTROL SYSTEMS 2017+ CYBER PHYSICAL SYSTEMS Internet of Things I II III IV INTEGRATION OF MANUFACTURING SYSTEMS Introduction of steam power for the operation of production plants Introduction of electricity, chemical and petroleum products Use of electronics and IT to further automate production SMART MANUFACTURING Use of smart machines interconnected and connected to the Internet 2

The right first question The right first question is not: What is the right technology to apply? Or How can I implement it? But Why do I apply it in Operations? 3

Creating Value for a long term Sustainability Improving: Overall efficiency Quality Health, Safety and Environment 4

1 Step: Value Analysis Value Chain Cost Deployment 5

PCM Project: Transformation Case Prioritization Matrix 6

Production Continuous Monitoring Business Value Assessment PCM project start-up stemmed from a business value assessment that highlighted the main business needs for our plant Value Stream Analysis 7

PCM Project Scope PCM - Production Continuous Monitoring ProHance @ syringe line, Colleretto BioIndustry Park Washing machine Filling machine Visual Inspection As part of I4.0 PCM project, we included three machines belonging to the ProHance@ Production line: Washing machine Filling machine Visual inspection These machines Do not communicate each other Do not «talk» together Have an own monitoring panel that let users access production data 8

From theory to practice What we had: Production line Process Knowledge Data from sensors People What we needed: infrastructure Cloud platform 9

Dashboard view: Example 1 Real-time vs Historical view switch Real-time parameter values Continuous data plots 10

Dashboard view: Example 2 PCM - Production Continuous Monitoring ProHance @ Syringes line, Colleretto BioIndustry Park Real-time vs Historical view switch Washing machine Filling machine Visual Inspection Machine name and status Real-time parameter values Lot ID Rolling bar showing machine behaviour in the past 4 hours, in terms of GO / STOP Semaphors associated to binary production data Alarms table (filled with occurred alarm IDs, descriptions, severity level, time) Continuous data plots 11

Next Steps: Analytics Descriptive analytics answer what happened, and are getting to some of the why did it happen with BI, visualization, and data science-integrated software Ensure we re building our analytics on a strong foundation Diagnostic analytics detect patterns and relationships and their true drivers to get to the real story and debunk false correlations With guided data discovery, it s possible to drill down into exact causes Predictive analytics a combination of advanced analytics capabilities that span statistical analysis, predictive modeling, data mining, text analytics, entity analytics, optimization and machine learning predictive analytics is more than a desktop tool that suggests the factors most likely to affect outcomes 12

Transition from Pharma to Chemical-Pharmaceutical The same approach can be applied to our Chemical Pharmaceutical plant. Our Plants are already managed and controlled by a MES (Manufacturing Execution System); key parameters, alarms and trends are already displayed and available for the operators. In this environment it will be easier to use a millions of data to improve the efficiency through the analytics. THE KEY will be to select the right step of the process (the right data) Bottleneck Critical step affecting the quality of the product Critical steps in terms of Safety or environment Of course the peculiar constrains will be considered (ex: ATEX guidelines) 13

Critical Success factors for the Digital Transformation Digital transformation demands a new operations strategy Keep data safe You still need people in a digital world Think beyond the possible Build your baseline Make people part of the plan Data is the real value Don t reinvent the wheel Recognize that you get what you pay for Look to the marketplace Create a trusted ecosystem Embrace cultural change. IBM Watson IoT Platform Physical and Digital Connected System 14

Some insights 15