SES

Modern technologies now make it possible to capture process data in real time, offering unprecedented visibility into manufacturing and quality operations. At the same time, advanced visualization tools allow this data to be presented in a streamlined and accessible manner, enabling faster and more informed decision-making. This presentation will explore how the integration of these technologies supports the implementation of a reinforced Ongoing Process Verification (OPV) framework.

In the rapidly evolving field of pharmaceutical manufacturing, addressing patient needs with agility is vital. A strong Ongoing Process Verification (OPV) initiative is essential for ensuring consistent product quality, operational efficiency, and regulatory compliance across a globally integrated network of standardized manufacturing facilities. This presentation explores establishing a comprehensive, digital, and connected OPV framework for fill and finish production lines, incorporating standardized equipment for each unit.

A Case Study, describing how ISPE Guidance was utilized to help a leading Life Sciences Organization Implement and Validate. The presentation will explain a real life example of utilizing guidance to get from the base steps of Connectivity to the enhanced interconnected plant. It will explain the steps taken by the organization, including initial risk assessment and the different interdisciplinary teams working together and phases required to realize the project and commission the new plant.

The global COVID-19 pandemic has exposed severe vulnerabilities in the pharmaceutical supply chain, leading to widespread drug shortages. Contributing factors include manufacturing disruptions, raw material scarcity, logistical constraints, increased demand, and regulatory challenges.

This topic will delve into the ways digital technology can support sustainability of pharmaceutical products, addressing both the opportunities and hurdles we face.

In today’s rapidly evolving pharmaceutical landscape, process optimization and quality assurance are essential to maintaining a competitive edge. This presentation explores a real-world case study from Recordation Cork, demonstrating how AI and data-driven tools have made an exponential improvement in production performance.

Manufacturing Execution Systems (MES) are a foundational Life Sciences digital manufacturing technology. Apart from the direct benefits of MES, it is a critical enabler for Pharma 4.0 as it provides real-time/accurate/secure manufacturing data and a vehicle for AI/ML technology use-cases including interconnected supply and manufacturing, predictive/prescriptive analytics, advanced modelling & simulation, vision systems, IIOT connectivity etc.

This is a joint presentation between Fujifilm Diosynth Biotechnologies and PM Group about a next generation aseptic robotic filling platform. The technology called AZZURRA has taken over 5 years to develop by a collaboration of different companies with the aim of overcoming the limitations and project delivery issues associated with existing filling technologies including the latest gloveless isolator offerings. Azzurra is part of the FDA Emerging Technology Programme and the EMA's Quality Innovation Group.

As the pharmaceutical industry advances toward the vision of Pharma 4.0, the transition from connected to predictive manufacturing environments is becoming a strategic priority. A key enabler of this transformation is Advanced Physical Layer (APL) Ethernet technology, which delivers high-speed, intrinsically safe, two-wire Ethernet communication directly to field-level devices in hazardous production environments.