Digitalization is becoming more common in the pharmaceutical industry, but integrating smart systems into manufacturing operations can be a challenge. Here, I explain how combining COPA-DATA’s zenon software platform with Werum PAS-X can reduce the integration and validation effort, reduce errors, and maintain compliance in pharmaceutical operations.
When it comes to digitalization in life sciences, one of the most important aspects is the transition from paper-based batch records to electronic ones. Here, one of the most complex challenges concerns the integration between shopfloor and manufacturing execution systems (MES). The lack of standards leads to increased integration and validation costs. Körber, a global software company, has designed an interface to simplify data integration between the commonly used Werum PAS-X MES system and operational technology (OT) systems like zenon.
Challenges in digitalization
The life sciences sector operates under strict regulations, requiring meticulous documentation of drug production in compliance with cGMP regulations. Currently, most pharmaceutical companies rely on paper-based batch records. The priority in life sciences digitalization is to transition from paper to digital through the adoption of Electronic batch records (EBR) facilitated by MES systems. However, implementation costs, architectural complexities and difficulties in integrating machinery with IT systems hinder widespread adoption.
The traditional approach to integrating machinery and production lines involves centralized process historian systems. While effective for storing time-series values, these systems have limitations in capturing critical Good Manufacturing Practice (GMP) exceptions like alarms and audit trail messages. The integration of alarms and audit trail data lacks standardization, often relying on customized machine-by-machine solutions, which increase complexity and integration costs.
Paradigm shift: Distributed data storages
Modern software platforms and SCADA systems at the OT level offer distributed data storage capabilities, eliminating the need for a centralized process historian. These platforms, such as zenon Service Engine, can generate and store electronic records, including time series, alarm lifecycles and audit trail records with metadata. Each machine becomes responsible for storing its real-time and historical data, significantly reducing engineering costs and simplifying the architecture overall.
Direct communication between MES and shopfloor
Werum PAS-X MES, a widely used system in the life sciences sector, introduced the Message-based Shopfloor Integration (MSI) interface to address the limitations of current OT-IT integrations. MSI enables bidirectional communication between PAS-X and production systems, ensuring reliability and data integrity. For seamless communication, the production machinery must also support the MSI interface.
Join forces for seamless digital processes
COPA-DATA is part of the Körber Ecosystem Partner program and has received the "PAS-X MSI Plug & Produce Ready" certification for zenon. In collaboration with Körber Software and leading pharmaceutical companies, COPA-DATA has developed a native Werum MSI interface within the zenon software platform. This interface facilitates direct communication between zenon and PAS-X MES. The configurable module allows the definition of MSI messages and mapping of their contents to zenon variables. Machine-specific MSI message definitions can be created and tested offline before machine delivery, reducing time-consuming activities. zenon also enables the selection of zenon alarms to be sent to PAS-X as GMP exceptions
Green field scenario
In a green field scenario, where new machinery is involved, zenon can be used as an on-board machine HMI. The machines can be pre-configured with a Werum MSI interface for classic batch operations and critical GMP alarm sharing. Machine manufacturers can agree on the messages to be exchanged with the MES in advance. Sharing the MSI message definitions and configuring communication addresses between the machine and PAS-X ensures integration without costly hierarchical solutions. Such machines are referred to as “PAS-X MSI Plug & Produce ready”.
Direct integration of PAS-X MSI Plug & Produce Ready machines with integrated Data Storage capability.
Brown field scenario
For existing machines that lack direct interfaces with Werum PAS-X or integrated data storage capabilities, zenon offers a modular and scalable middleware solution called Automation Integration Layer (AIL). AIL enables integration with legacy PLCs and field equipment, contextualization and historicization of data, and integration with Werum PAS-X via the MSI interface. Existing machines can be connected to the MES system through the AIL, allowing batch contextualization and the transmission of collected information such as counters and GMP alarms at the end of the batch.
zenon as a modular Automation Integration Layer, including Data Storage, Reporting and IT integration.
To overcome the challenges of implementing EBR systems and to enable effective, standardized integration, solutions like Werum MSI and zenon MSI interface can streamline the connection between Werum PAS-X MES and machines. The use of Werum MSI ready machines and zenon's Automation Integration Layer offers a cost-effective and flexible approach for both new and existing machinery. By embracing digitalization and leveraging advanced software platforms, life sciences companies can embark on a seamless journey towards a digital plant.
Find out more here.