Alarm Management System Makes Compliance Easier for Biopharmaceutical Company

Project Summary:

Merck & Co., Inc., the premier research-intensive biopharmaceutical company in the world, requested Grantek’s assistance in building an alarm management system with the Ignition SCADA platform for its facility in West Point, PA. This solution provides alarm monitoring, historization, and a management interface for 10,000+ points while also delivering ad hoc and scheduled reporting tools to aid in the rationalization of up to 30,000 alarm events per day. Grantek’s solution, built with Ignition Perspective, also provides point change management and tracking tools to assist site administrators in maintaining the associated point metadata. These results would be difficult to achieve without Ignition’s versatile capabilities.

Problem:

Merck reached out to Grantek for help providing an alarm management system with the use of the Ignition SCADA system software at their facility in West Point, Pennsylvania. Managing and monitoring alarms is vital in the highly regulated pharmaceutical manufacturing industry, and the U.S. Food & Drug Administration continues to show an interest in alarming management. This project involved installing a new Ignition system to handle alarming at the facility.

The system needed the ability to add various alarm data from existing Siemens PLCs and through OPC tags for different systems on site. To keep the configuration setup as simple as possible, all data was mapped through the existing Matrikon OPC Server. This eliminated the need to verify all tags back to the PLCs or other systems while also simplifying the overall tag verification for the existing system. Tags connecting to Siemens controllers were connected through the Ignition OPC Server.

The alarming system had to provide all levels of alarm management for the configured tags, and a variety of metadata type options. As part of the alarm system, the user needed the ability to enter comments for each active alarm that would be historized and available for review via reports and the alarm’s history. The alarm system will also work in conjunction with Active Directory to access a list of designated users and populate the given parameters that are made available. User profiles and characteristics also had to be created. Additionally, reports needed to be configured to be filterable by time (day/week/month), severity, category, and users.

Solution:

Merck selected Ignition by Inductive Automation as the SCADA system for this solution. Grantek recommended Ignition Perspective, as it is uniquely positioned to deliver the results Merck wanted to achieve. The solution had a connection to 22,000 tags and 11,000 alarm points through an OPC/DA server architecture, while also providing a future avenue to connect 96 new Allen Bradley PLCs directly to the gateway. To ensure a user-friendly experience for Merck operators and managers, a real-time alarm management workflow was developed to allow operators to view, dispatch, acknowledge, and annotate unique alarm events through the life cycle of the event. Perspective views for high-density alarm summary and alarm history were also developed to let users perform advanced filtering of the alarm tables as needed. This feature also allows operators and management to view all relative metadata and response status in a conveniently docked pane.

Results:

This solution provided Merck with an application that enables well-defined management (dispatching, answering, annotating, and monitoring) of all alarms (up to 10,000 alarm events per day). Furthermore, the solution lets application administrators perform in-depth configuration updates to existing alarms points (and associated metadata including setpoints, sensor details, troubleshooting steps, owners, and various other details) and the ability to add and configure new alarms through the application’s frontend. Additional features included automatic notifications and report distribution, and a high-availability DB architecture allowing for historical retention of an immense amount of alarm information.

The system delivered custom data archiving to Merck, which automatically creates archive tables for the ALARM_EVENTS and ALARM_EVENT_DATA tables and moves events to the archive tables at the defined interval. A report schedule builder was also developed, letting management and administrators schedule any of the 10 pre-built reports on daily, weekly, or monthly periods and specify the recipient, report parameters, and report format from the UI.

To provide more flexibility, the ad hoc and filterable reports let users view historical events in highly customized formats. This feature can also be helpful in the event of a regulatory review or audit. The UI tools allow authorized users to manage points from the system’s frontend. They will be able to change point metadata, alarm parameters, point owners, and specify users who will be notified by email or text if the point enters an alarm state. Alternatively, users can export point data to a CSV file from the Ignition Perspective application, make necessary edits, and re-import the CSV file into the application to modify points. 

UI tools were incorporated into this solution to provide workflow for users to request changes to points while allowing system administrators to track the progress of the changes and record annotation. Grantek’s solution also provides AD integration and workflow so that system administrators can approve or deny new users or role changes.

Grantek’s Ignition-based solution equips Merck with a reliable, adaptable, and consistent alarm management system that can be used by operators and trusted by management to display dependable insights.

Deploy Date: May 2023