Data Collection and Logging in Pharmaceutical Manufacturing
September 15, 2020
A pharmaceutical manufacturer client requested Grantek’s assistance to upgrade the control system of their Fluid Bed systems in two production rooms at their facility. One Fluid Bed system needed to be upgraded to a larger ControlLogix processer and graphic 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 and Grantek decided to use this SCADA project as an opportunity to pilot a comprehensive data integrity solution using Ignition. As part of this project, Grantek collected and determined the client’s requirements regarding data integrity and build feature sets which helped them comply with those requirements into Ignition. Grantek followed a holistic approach to gather requirements and develop implementation such that the solution can be applied to the fluid bed and other system types in their operations.
Grantek had extensive knowledge this facility and the SCADA requirements, including previous work in adding and maintaining the EMS system. Grantek’s combination of expertise in Ignition Platform technology, 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 re-used as much as possible and Grantek utilized an approach that leaves 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 5 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.
One of the Fluid Beds is 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 is 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.
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. Several of the priority concerns addressed by this project are adding a robust role-based access controls to aspects they are qualified for, 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 asides from several additions to accommodate new HMI features. This allows for the transition to compliance while maintaining familiarity for operators working with the system.