Improved Data Integrity and Easier Compliance with 21 CFR Part 11

Project Scope

• Tags: 4,367
• Screens: 49
• Clients: one, desktop workstation in the same room as the fluid bed
• Alarms: 92
• Devices used: one, ControlLogix L82E
• Architectures used: Standard
• Databases used: MySQL
• Historical data logged: No Historical tags used; tag data and user action data is stored and written to MySQL tables. Data can then be viewed from reports within Ignition.

Project Overview

Par Pharmaceutical worked with Grantek as part of Par’s corporate data integrity initiative to improve production data quality and regulatory compliance. The project related to fluid beds, which are pieces of equipment used to reduce the moisture content of pharmaceutical powder and granules. The project was to draft corporate data integrity requirements for all control systems across Par Pharmaceutical's industries, and then develop a new system for the fluid bed as a pilot against the new requirements.

Par Pharmaceutical in New York requested Grantek's assistance to upgrade the control system for one of its fluid beds. The project was technically to upgrade the SCADA of the machine; however, the business objective of the project was to improve the company's data integrity, regulatory compliance, and process data retention. The goal was to formalize the control system requirements to satisfy data integrity objectives, and then build a control system against those requirements to pilot its effectiveness.

One fluid bed system needed to be upgraded to a larger ControlLogix processor and graphics migrated to the Ignition platform. The other fluid bed system needed to have its PLC-5 equipment and logic migrated to ControlLogix as well as its graphical interface migrated to Ignition.

Additionally, the client needed these specific features included in the design: recipe management which may be used or bypassed, batch reporting which may be used or disabled, and full maintenance/calibration features. The client needed to solve a recurring problem with vendor support, as the incumbent system was running on Windows XP. To reliably improve productivity, the client needed a solution that would provide the needed data integrity while also being easy to use and scale. Inductive Automation’s Ignition was best positioned to do just that.

Grantek collected and determined the client’s requirements regarding data integrity and built feature sets which helped the client comply with those requirements in Ignition. Grantek followed a holistic approach to gather requirements and develop an implementation such that the solution can be applied to the fluid bed and other system types in Par’s operations.

Grantek had extensive knowledge of this facility and the SCADA requirements, including from previous work in adding and maintaining the EMS system. Grantek’s combination of expertise in Ignition, the fluid bed operational process, and 21 CFR Part 11 and data integrity industry standard compliance made Grantek an ideal candidate for this project.

Grantek was also tasked with building an option to provide validation documentation and execution services. The controls logic was reused as much as possible and Grantek utilized an approach that will leave both fluid beds running very similar logic.

The fluid bed dryer solution provided by Grantek is a critical piece of process equipment involved in the manufacturing of solid dose pharmaceuticals. This solution ensures each fluid bed control system utilizes five main process phases: pre-conditioning, charging, heating, spraying, and cooling — each involving a sequencing of air flow, temperature control, or spray per a pre-configured (but editable) manufacturing recipe.

Previously, one of the fluid beds was being controlled by a ControlLogix 5562 processor with an iFix SCADA HMI and custom Visual Basic interfaces and scripts. In contrast, the other Fluid Bed was controlled via a PLC-5 with a Wonderware SCADA HMI. The client also upgraded the air handler and other process equipment as part of the migration included in this project. The solution provided by Grantek utilized the Sepasoft module for recipe management within Ignition to organize and manage all recipe creation and versioning. The tight integration of Ignition with the database also allowed for robust filtering and data validation using dropdowns and search-fields objects.

As data becomes the driver behind critical business decisions, it is becoming ever more critical to ensure that data is handled correctly, following industry best practices. These projects reviewed the shortcomings of the antiquated fluid bed dryers to identify risk areas that could lead to errors in electronic records, or compromise data integrity. This solution removed the barriers to documentation and sped up data retrieval. Several of the priority concerns addressed by this project are adding robust role-based access controls, modernizing the audit trail to improve mean time to resolution, and implementing electronic signatures to approve critical operating changes or events.

These projects further facilitate the collection of trusted data while increasing the availability of actionable data to allow users to improve operations. While the interface was updated for these features, the PLC operations were identical aside from several additions to accommodate new HMI features. This allows for the transition to compliance while maintaining familiarity for operators working with the system.

In terms of data integrity improvement, data reporting capability, change tracking capability, and data retention, the project was a very strong success.

The highlight of this project and its value is using Ignition as a centralized data repository and 21 CFR Part 11/data integrity compliance tool. Par is now working on centralizing many machines’ controls into Ignition.