In this ISPE Expert Xchange: Enabling Pharma 4.0™ through Plug and Produce, we will assess opportunities and gaps for the digital transformation of bio-pharmaceutical manufacturing, including regulatory compliance aspects.
How do we translate bio-pharma business needs into digital reality? This ISPE Expert Xchange covers the bio-pharma specific aspects of the digital transformation specifically on machine, equipment, and device (sensor) integration for realizing the benefits of Pharma 4.0™. We present the latest insights and conclusions from the workstreams of the ISPE Pharma 4.0™ Plug and Produce workgroup. We will explain and demonstrate principles and technologies that enable Holistic Control Strategy that are based on integration of product, process, and manufacturing related data, including analytical lab results to address the pain-points experienced today. Practical examples from recent proof of concept projects and hackathons will be provided.
In addition, YOU get a seat at the table with these leading industry subject matter experts and your peers during the interactive topic-focused small group discussions where you will gain first-hand strategic insights and walk away with new connections, and actionable takeaways that will directly impact you, your organization, and the pharma industry.
Introduction to the Pharma 4.0 Plug and Produce problem and solution space Presenter: Wolfgang Winter
How do we translate the business needs into the digital reality of Pharma 4.0?
What is needed for the integration of OT and IT?
How to approach Pharma 4.0 “Plug and Produce” in practice?
Plug and Produce Architecture - In a world where IT technologies change at a fast pace, Pharma operators are faced with two major questions: Presenter: Anton Granget, Kim Hewson
How to achieve fast, flexible and low-cost validated connectivity between machines, IT-systems and humans to find smart data-driven answers to use-cases all around the shop floor and enterprise?
How to ensure that what is being implemented today in terms of IT/OT technology is not doomed to become obsolete the day after the project is done?There is a consensus that the traditional „one-system-fits-all“ approach is legacy thinking. This leads to a paradigm shift from how to interconnect all the systems to how to create an architecture that can onboard new applications for innovative use-cases fast and in a validated manner. Also, today the typical business user faces the problem that data required for the realization of such use-cases must be pre-processed, which leads to a significant loss of agility and reactivity. The opposite of what we want.
Specific requirements for Plug and Produce – How the shop floor will be supported by an intelligent and scalable infrastructure? –Presenter: Rod Hoffman, Henrik Stellmann, Josef Trapl
This face-to-face forum gives you the chance to have 1:1 conversations in small groups via video chat. Connect with attendees and engage with the speakers about their topics during this networking break.
PoC “Sensor, Machine, Equipment and system connectivity” – OPC-UA interface demo and discussion based on the newest published concept paper “Connectivity between shop floor & manufacturing operation management system OPC UA – a tangible step towards OPC-UA which presents a solution for standardizing an important aspect of plug and produce namely the transaction interaction between ISA 95 level 2 and level 3”. Presenter: Henrik Stellmann
PoC “Micro-service based integration between machines and IT systems” – Presenter: Giuseppe Menin. In this session we want to show a first practical step to realize a micro-service based integration between machines and IT systems in the frame of a proof-of-concept project. The approach is based around modularized connectivity services that are run in an application-neutral middleware component. Using a machine simulator with a full stack OPC UA capabilities, we will show how we intend to get away from a tag-based integration approach to a service-oriented one, with the use of a message broker. Our exemplary use-case is triggering a batch on the simulator machine. In mid-term we want to show how semantical abstraction within the connectivity micro-services can facilitate a decoupling of systems, thereby creating an interoperable, flexible and extendable architecture.
PoC “Fermenter, Admin shell concept and Digital Twin” – Presenter: Martin Mayer, Christian Schömer As the PnP focused in different workstreams the focus of WS3 is considering the customer focus. From that point of view the idea was to including the findings of the other workstreams and realize it based on an equipment including all the environment typically found in industry (DCS, IT constraints, …) and combining it with use cases with the customer in focus. The use case we focus in the first step is formulated: As Head of Production, I want a new IoT temperature sensor integrated with my bioreactor and to be informed as soon as the sensor is going live – independent from where I am, by opening my production dashboard on my mobile. Based on that user needs we elaborated some focus topics to cover in the PoC:
Architecture / IT Concept:
Roles of IT Systems/software packages, hardware devices, Structure: local - cloud
Technical connectivity:
Fermenter: Standard OPC UA, Data Model Tag Based
Smart Sensor: Blue tooth 4.0 – Edge Device – MQTT to cloud
Functionalities:
Auto log on/login of Smart Sensor/Edge Device - Security
Combination of Sensor Data and Fermenter data to ONE logical entity (Digital Twin)
Information on mobile device anywhere, anytime
: Next Steps/Questions:
How does standardization (Admin Shell) support this concept?
How to structure complex equipment (Fermenter) via Admin Shell?The realization is currently ongoing at the TechCenter in Austria using a Stainless Steel Fermenter 60l, GMP compliant, fully automated, DCS including OPC UA connectivity, a cloud application, Edge Device and Sensor for the fermenter
This face-to-face forum gives you the chance to have 1:1 conversations in small groups via video chat. Connect with attendees and engage with the speakers about their topics during this networking break.
*ISPE Membership is required for these registration rates.
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