New Control System Improves Safety and Compliance for Pharmaceutical Company

Project Summary:

Initially, Zendal approached Optomation Systems to tackle their needs for monitoring unmanned storage units holding pharmaceutical final products for their customers. When Optomation introduced Ignition, it rapidly evolved into a larger project with a broader scope to encompass the data acquisition of varied equipment, process control and supervision, alarm notification, data historization, and automatic report generation.

The main objective of the project was to implement a system that acts as a data repository for the information collected from the dedicated equipment in the different production areas and auxiliary services, both to satisfy regulatory requirements and prove compliance with CDMO obligations to customers.

In addition, the system integrated new production areas into the system and expanded functionality to include control and supervision of several processes. Field devices and sensors are connected to controllers that execute automated sequences, and from Ignition, operators have full access to the operation, just like a traditional SCADA system.

Problem:

One of the main problems for Zendal was that the freezers and cold rooms for the final products are spread throughout the site and are mostly unmanned, even during working hours. To ensure safety and compliance, set-apart personnel were required to regularly inspect the installations to record data and check for equipment failures.

New products and regulatory requirements also brought in new process units in the form of dedicated equipment (autoclaves, incubators, particle counters, etc.) or skid units with their own data retention mechanisms. This created a labyrinth of data formats, device connections, and communication protocols leading to information silos that were really hard to sort out.

Lastly, the increased production heightened the demand for operations such as connecting skid units or cleaning, which are normally performed manually, to be automated to increase speed, repeatability, and product safety.

Solution:

Selecting the proper architecture design along with Ignition’s unique features, provided the solution for network and area distribution concerns. The hub & spoke architecture with gateway nodes placed locally in each production area ensures that all data collection is independent of the network backbone. Using Ignition Edge in Opto 22’s groov EPIC controllers, combined with Ignition’s Store and Forward mechanism, safeguards historical data in the event of communication problems and guarantees that the central node receives all data for long-term storage.

The system leveraged I/O and programming capabilities of the groov EPIC controllers to achieve the full potential of this segmented design. In practice, each groov EPIC becomes a node in the gateway network that can perform data acquisition, process control, operator interface and data synchronization in a self-contained unit that is independent of the network and other areas.

The gateway network provides the appropriate protection and cybersecurity for data traveling the network backbone, while the physical separation of the IT and OT networks protects all the data sources such as standard laboratory or production equipment with legacy protocols or unsecure access.

For the non-process controlled, unmanned areas, the combination of Ignition’s Alarm Notification and Voice Notification modules provided the perfect solution for the maintenance teams. By monitoring both device alarm contacts and process conditions, the system can provide notifications to selected users using visual elements, e-mail notifications, and in some critical cases, by phone calls to on-duty staff and on-call crews.

By carefully using the unique features of Vision and Perspective, combined with the ability to provide multiple projects within the same license space, the system can easily tackle the different requirements of all its users. 

• Operators, production supervisors, and quality technicians gain access to production using screens in Vision clients created for each plant area. 
• Managers for production, product, or quality have access to all the plant’s data with Perspective where views were created to unleash the amazing customization of Power Charts, so users can create and save their own charts, check dashboards, or export data for advanced data analysis.
• The Quality Assurance department gets automatically generated and pre-formatted reports for key equipment.  

Results: 

Besides the evident benefits from going from a manual and non-automated data recollection and supervision to a new and modern automated system, the project also showed the amazing scalability of Ignition.

The extensive use of UDTs to template analyzers and other typical pharmaceutical equipment permitted new equipment to be rapidly incorporated anywhere in the plant, saving time, resources and, ultimately, money. Also, the breakthrough licensing model of Inductive Automation gives the customer the confidence and predictability to keep growing the system.

As a CDMO, Zendal is continuously adapting their installations to its customers’ needs, not to mention that for Zendal and its customers the speed to market is crucial for the business. Ignition’s flexibility and scalability has proved to be the right choice to adapt to Zendal’s ever-changing needs.

Start Date: 11/2020

Deploy Date: Ongoing