Introduction

In the rapidly evolving pharmaceutical industry, the need for real-time data collection, analysis, and visualisation have become crucial for maintaining operational efficiency and compliance. Réalta Technologies has demonstrated its expertise in this domain by successfully implementing a High-Availability PI System at a BioPharma site specialising in Fill Finish operations. 

This case study is one example of many full PI System implementations we have completed this year and highlights the advanced systems and technologies integrated by Réalta Technologies and the significant benefits they bring to the site.

Understanding the Customer’s Requirements

The BioPharma site required a robust and reliable system capable of collecting, storing, analysing, and visualising both real-time and historical operational data from various critical areas within the facility. These areas included the Formulations Suite, Component Preparation, Filling & Inspection, Labs, Clean and Black Utilities, and the Building Management System (BMS). The primary objective was to implement a High-Availability PI System that could integrate seamlessly with existing systems and provide comprehensive insights into operational performance.

Systems Integrated

Réalta Technologies expertly integrated a range of systems to achieve the desired outcomes for the BioPharma site:

• • DeltaV Batch System: Facilitates precise control and monitoring of batch processes, ensuring consistency and quality in production.
  • Syncade MES: Provides Manufacturing Execution System (MES) capabilities, enhancing production management and compliance.
  • Siemens & Allen Bradley PLC’s and HMI’s: Critical for controlling and monitoring automated processes and equipment across the site.
  • Desigo BMS: Manages building systems such as HVAC, lighting, and security to ensure a controlled environment.
  • LIMS (Laboratory Information Management System): Streamlines lab operations by managing samples, associated data, and laboratory workflows, ensuring data integrity and compliance.

Technologies Deployed

To meet the complex requirements of the BioPharma site, Réalta Technologies employed a suite of advanced technologies that work in tandem to deliver real-time insights and analytics:

• PI Data Archive: Redundant central repository for all operational data, ensuring secure and efficient data storage.
• PI Asset Framework (AF): Provides a contextualised representation of data, enabling users to easily navigate and analyse information.
• MS SQL Server: Allows redundancy and robust support for the databases used for the PI system’s Metadata
• PI Analytics: Allows for the creation of sophisticated analytics models, providing actionable insights from the collected data.
• PI Vision & Datalink: Facilitates intuitive data visualisation and interaction through dashboards and reporting tools.
• PI Event Frames Generator (EFGen): Generates event frames for tracking process events and exceptions, crucial for batch reporting.
• PI Notifications: Automates alerts and notifications, ensuring timely response to critical conditions.
• RtReports: Enables comprehensive reporting and review by exception, streamlining compliance and quality assurance processes.
• PI Integrator for Business Analytics: Integrates PI System data with business intelligence tools, enhancing strategic decision-making.
• PI WebAPI: Provides programmatic access to PI System data, enabling custom applications and integrations.
• Python: Utilised for developing custom scripts and analytics models, further extending the system’s capabilities.
• PowerBI: A powerful tool for creating interactive and insightful business intelligence reports, integrating seamlessly with the PI System.
• PI Interfaces: Enables reliable collection of data from multiple sources like OPC Servers, PLC, relational databases, Batch Execution Systems

Rationale for the Systems and Technologies Used

Each technology and system integrated by Réalta Technologies was carefully selected to meet the specific needs of the BioPharma site:

• High-Availability and Redundancy: The PI System architecture ensures continuous operation with minimal downtime, critical for maintaining uninterrupted production and compliance.
• Real-Time Data Visibility: Integrating PI Vision, Datalink, and PI Analytics provides stakeholders with real-time access to operational data, enabling proactive decision-making.
• Advanced Reporting and Analysis: Tools such as RtReports, PI EFGen, and PI Integrator for Business Analytics enable detailed reporting, exception-based review, and in-depth analysis of critical process parameters (CPP) and batch performance.
• Seamless Integration with Existing Systems: The PI System’s compatibility with DeltaV, Syncade MES, and various PLCs ensures a smooth integration process, preserving existing investments in technology.
• Customisable and Scalable Solutions: The use of Python and PowerBI allows for the development of custom analytics and reports, tailored to the site’s specific needs, while providing scalability for future expansion.

Use Cases and Benefits

The implementation of the High-Availability PI System has enabled the BioPharma site to achieve significant improvements in operational efficiency and data-driven decision-making. Key use cases include:

• Alarms Notifications and Reporting: Automated alerts and detailed reporting on alarms ensure quick response to critical issues, minimising downtime and enhancing safety.
• Downtime Reporting: Accurate tracking and analysis of downtime events help identify root causes and implement corrective actions, reducing production losses.
• Critical Process Parameter (CPP) Reporting: Continuous monitoring and reporting of CPPs ensure that production stays within defined parameters, maintaining product quality and compliance.
• Batch Reporting with Review by Exception Strategy: Streamlines batch reporting processes, focusing only on deviations and exceptions, which reduces the time required for quality reviews.
• Batch Analysis & Comparison Dashboards: Visual dashboards allow for easy comparison of batch performance over time, helping to identify trends and optimise processes.
• Energy Monitoring Dashboards: Provides insights into energy consumption patterns, enabling the site to implement energy-saving initiatives and reduce operational costs.

Conclusion

Réalta Technologies has once again demonstrated its expertise in implementing advanced technological solutions for the pharmaceutical industry. By deploying a High-Availability PI System at the BioPharma site, Réalta has enabled the site to achieve greater operational efficiency, enhanced data-driven decision-making, and improved compliance with industry regulations. The successful integration of multiple systems and the deployment of cutting-edge technologies highlight Réalta Technologies’ commitment to delivering customised, high-performance solutions that meet the unique needs of their clients.

If you’d like to discuss your challenges or how we can help your data work better for you, contact us today.

sales@realtatechnologies.com 

+353 21 2439113

FAQs

1. What is a High-Availability PI System?
   A High-Availability PI System is a robust data infrastructure that ensures continuous operation with minimal downtime. It is designed to collect, store, and analyse real-time and historical data, providing businesses with actionable insights and ensuring operational continuity.
2. How does the PI System enhance operational efficiency?
   The PI System enhances operational efficiency by providing real-time visibility into critical processes, automating alerts and notifications, and enabling advanced data analysis. This allows businesses to proactively address issues, optimise processes, and make informed decisions.
3. What is the role of PI Vision in the PI System?
   PI Vision is a visualisation tool within the PI System that allows users to create interactive dashboards and displays. It enables real-time monitoring of operational data, making it easier for stakeholders to identify trends, anomalies, and opportunities for improvement.
4. Why is integration with existing systems important?
   Integration with existing systems is crucial as it ensures that the PI System can seamlessly collect and analyse data from various sources without disrupting current operations. This preserves the value of existing technology investments and minimises implementation challenges.
5. How can businesses benefit from energy monitoring dashboards?
   Energy monitoring dashboards provide businesses with insights into their energy consumption patterns. By analysing this data, companies can identify areas of inefficiency, implement energy-saving initiatives, and reduce operational costs, contributing to sustainability goals.