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Global Pharmaceutical Optimizes Electronic Batch Records

With the pharmaceutical industry pushing for ever greater plant optimization, a major pharma manufacturer updated its batch processing platform and improved its electronic batch record process.

The pharmaceutical industry isn’t becoming less complex or competitive anytime soon. In addition to expiring drug patents, more stringent regulations, and a growing number of manufacturing applications, the ongoing drive toward continuous processing is keeping the industry on its toes.

In 2016, for example, a $4.4 million contract given to Continuus Pharmaceuticals by the U.S. Food and Drug Administration (FDA) explored how pharmaceutical companies could break the batch habit in favor of a continuous approach to drug production. In addition, the FDA issued a draft guidance in 2019 to further support the development and implementation of continuous manufacturing for branded, generic, and over-the-counter drugs.

While the shift toward greater use of continuous processing methods continues, individual pharmaceutical companies are still evaluating older, legacy batch production platforms for ways to optimize new smart manufacturing technology. One global pharmaceutical company facing this challenge looked to Werum IT Solutions, an international supplier of manufacturing execution system (MES) software, and system integrator Grantek to help it undertake a modernization initiative aimed at supporting production of more than 20 SKUs.

The pharma company—which has net profits of more than $3 billion most years—needed to update a batch production area for its liquid injectable product line. Its original operations relied on a supervisory control and data acquisition (SCADA) system with an Oracle database to store data. The SCADA system communicated with 13 different programmable logic controllers (PLCs). The Oracle database stored recipes defining phase parameters, sequencing, and phase entry/exit criteria. Recipe processing was handled by a GE iFix platform.

To begin its modernization effort, the pharma company selected Werum’s PAS-X MES software to support its batch processing production. The MES platform provides master batch records (MBRs), electronic batch records (EBRs), and equipment management components, and is backed by other Werum services supporting integration and process development.

The new system replaced iFix and the Oracle database and reduced the numerous diverse PLCs to three ControlLogix PLCs from Rockwell Automation. Two of the new PLCs control the process using existing converted code from the legacy controllers, and the third functions as the recipe controller and data concentrator that monitors the batch execution and data.

Once the MES was in place, the company’s next goal was to ensure data integrity measures were implemented to feed information into the EBR system. To achieve this integration, the pharma company called on Grantek and its extensive experience in connecting enterprise systems.

Part of the challenge for Grantek was converting the code from the 13 legacy PLCs to the two ControlLogix PLCs. “The biggest challenge for the project was emulating the operations of vBatch in the PLC,” says Patric Brown, director of engineering at Grantek. “The objective was to maintain the integrity of the original controlling phase logic and to minimize validation efforts.”

Grantek accomplished this by emulating vBatch as a recipe control/supervisory system within the recipe of the new data concentrator PLC. The system integrator implemented communication interface changes between the original PLCs—now residing on the same PLC—and made minor code tweaks to accommodate the difference in technology between the existing and new PLCs. It maintained proper communication links between the original 13 PLCs, with these links becoming intra-PLC links while others remained inter-PLC communications.

The pharmaceutical giant required its new batch system to store the recipes in the PLC to further secure and limit access to them. It defined these 80+ recipes based on those existing in vBatch. The company stored these batch recipes as Excel files and entered them into the Recipe PLC using a custom-developed tool from Grantek.

The electronic batch records and lab results—using Abbott Informatics’ StarLIMS Laboratory Information Management System—are stored in a database via the MES. Other system software components include an OSIsoft PI historian, which collects batch production data and moves it into a SQL database.

Rockwell Automation’s FactoryTalk Alarms and Events logs events in the data concentrator PLC and provides a central location for alarm notifications and text. The design routes alarms from the two batch processing PLCs to the data concentrator PLC.

Besides the minimal control code updates, Grantek designed the communication interface between the MES platform and PLC levels, reused the MES-designed component routines from the PAS-X platform, and delivered minimal configuration of the OPC data server in this project.

The pharmaceutical industry is moving quickly toward increased efficiencies and optimization at the production level. This application highlights how modernization initiatives are helping global companies replace older automation technology without ripping and replacing the entire factory.

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