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2022 ISPE Annual Meeting & Expo

SES101b - Pharma 4.0 Transformation in Motion – Plug and Produce Examples in Practice

Oct 31, 2022 11:00am ‐ Oct 31, 2022 12:30pm


This presentation begins with an explanation of the architectural principles of Pharma 4.0 Plug and Produce. This will be achieved through a Service Oriented Architecture (SOA) that decouples systems and encapsulates complexity with security and interoperability. This ensures
• System harmonization
• Vendor-agnostic, end-to-end connectivity and data exchange from shop-floor to enterprise, including the supporting functions such as the analytical laboratory
• Creation of higher level knowledge and insights based on this data to facilitate holistic process understanding

We will discuss several pilot implementations from members of the Pharma 4.0 Plug & Produce workgroup. This includes insights from two Hackathons and three proof-of-concept projects executed within the workgroup as well as the Pharma 4.0 showcase project implemented at Takeda in Germany and featured as Pharma 4.0 Facility of the Year Award Winner in 2022. The projects demonstrate the integration of diverse Operational Technology systems, interfacing to the Enterprise level and its data backbone to drive digitalized processes, e.g. environmental monitoring, AI-based automated visual inspection, real time performance monitoring of an entire plant.

These steps are significant to increase the level of process knowledge and understanding in a holistic fashion, eliminating the risk related with process variations that are not properly understood and which cannot be explained. This reduces the number of non-critical process parameters that are often baked into registration filings and which consume bandwidth and effort for little or no return in terms of documentation, change control, deviation handling and investigations.

We will then present an outlook on the next steps of the Pharma 4.0 Plug and Produce Roadmap. In addition to the pilots involving package units, analytical lab equipment and fermenters, one project is exploring the Industry 4.0 concept of the Asset Administration Shell as an enabling step towards the application of Digital Twins.


  • Josef Trapl, Head of MSci Innovation, GMS / Manufacturing Science, Takeda
  • Wolfgang Winter, Director, Informatics Platform R&D, Agilent Technologies R&D Mktg GmbH & Co KG

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