Session Highlights and Why They Matter
“Process Data Capture using Advanced Physical Layer (APL)”
Learn how APL Ethernet delivers high-speed, intrinsically safe data directly from field devices, supporting predictive analytics and AI-driven optimization.
Why it matters: This is one of the first implementations of APL within the pharmaceutical industry —engineers will gain practical insight into network design, device interoperability, and information technology/operational technology integration.
Learn how Sanofi designed a new smart large-scale pharmaceutical production facility, which integrates real-time data capture, analysis, and visualization. Sanofi’s case study example will provide real-world insights into how a company can successfully navigate implementation and design challenges that have been associated with deploying this emerging technology in a greenfield project.
“Ongoing Process Verification 4.0”
See how real-time monitoring and advanced visualization can transform OPV from a static compliance activity into a dynamic, proactive risk management tool.
Why it matters: Continuous monitoring enhances agility, helping manufacturers stay aligned with regulatory expectations while improving efficiency and product consistency.
The blog post authors look forward to learning about how the practical integration of advanced visualization tools can support the effective implementation of an automated OPV program. Attendees will learn about the main challenges and what benefits the speakers with Alrmirall, a global dermatology pharmaceutical company, have harvested thus far as a result of their efforts.
“Data Integrity and Real-Time Recording in Microbiological Quality Control (QC)”
Explore how digital tools can enhance data integrity and enable real-time data capture in microbiological QC with a use case involving SmartReg, a GMP-compliant, voice-operated electronic batch records/manufacturing execution systems platform. The platform has been embedded sterility pumps distributed by Merck, enabling hands-free data capture that maintains compliance and traceability while working under laminar flow hoods which can be more cumbersome to move around in.
Why it matters: For engineers, this represents a leap in operator efficiency and error reduction while ensuring ALCOA+ compliance.
This session shows an exciting way to use data in real-time in the labs to increase efficiency.
Key Takeaways
- Learn how hands-free digital tools like SmartReg can improve aseptic workflows while ensuring compliance
- Hear about one of the industry’s first successful implementations of APL Ethernet, a breakthrough enabler of predictive manufacturing and process optimization
- Uncover how global OPV frameworks can drive standardization, scalability, and faster tech transfers
- Delve into real-time visualization tools, which are making OPV 4.0 a driver of agility and continuous improvement
“What excites me most about this track is how each session brings digital transformation into real-world engineering and real-world future manufacturing of medicinal products. From visions and design strategies to practical implementation on the shop floor,” said Lundsberg-Nielsen.
“These sessions are more than theory; they are also practical examples of how to transform data into decisions, and decisions into measurable quality improvements,” said Sofie Strejby Thomsen, Consultant for NNE.
ISPE looks forward to welcoming 2025 ISPE Pharma 4.0™ Conference attendees to join sessions from the Data-Driven Quality Decisions track.
Learn more and register for the 2025 ISPE Pharma 4.0™ Conference.
