When you make active ingredients for generic pharmaceuticals, you're always multitasking: chasing time, introducing new products, seeking stable production volumes and maintaining compliance.
So any help with these jobs is greatly appreciated.
That’s according to Girish Deshmukh, vice president of engineering and projects, Dr. Reddy's Laboratories Ltd., Hyderabad, India.
His company wanted to logbooks linked to their historians, recipe workflow execution and batch control data because they need manufacturing intelligence.
Then they could add overall equipment effectiveness (OEE) and other data sources, and generate batch reports and verifications about production downtime and moving quality targets.
Overall, the $2-billion firm runs three businesses—pharmaceutical services and active ingredients, global generics, and proprietary products—and their products and services include APIs, custom drug services, generics, biosimilars and differentiated formulations.
Dr. Reddy's began its latest trip to performance optimization through better data in 2010 at its active pharmaceutical ingredients (API) plant in Visakhapatnam, India, and is driving operational excellence by expanding its combined distributed control system/manufacturing execution system (DCS/MES) at the facility.
The project's first phase included 9,800 I/O points, servers and software that began operating in 2014. Equipment monitored and managed at the plant include reactors, centrifuges, dryers, weigh scales, barcode scanners and other support devices.
“This combined DCS/MES architecture gives us quick changeovers when we need to manufacture drugs fast, and the flexibility to design new recipes and products when needed," said Girish Deshmukh, vice president of engineering and projects, Dr. Reddy's Laboratories Ltd.
They began working with Rockwell Automation when they integrated the DCS and MES, and enhanced operational transparency to improve quality and meet regulatory norms.
Together they integrated and connected the plant's quality by design (QBD) and supervisory control and data acquisition (SCADA) functions like online recipe management, and implemented an action plan to enable multivariate analysis and other capabilities.
Because the API plant used to have so many manual operations and documentation, Deshmuhk says all those human interventions could slow it down.
Consequently, the plant's architecture was revamped to include the PlantPAx modern distributed control system as its DCS, PharmaSuite software at the MES level, and SAP for enterprise resource planning. These enabled common views into operations, while also reducing software and spare equipment inventories, required training and control hardware.
Dr. Reddy's learned several valuable lessons from implementing its combined DCS/MES architecture at the API plant. For example, they discovered how much learning and adaptation the new system would need.
They also learned it's important to incorporate site-specific feedback during deployment, organize change management and have adequate resources with each partner.
However, the result is that they now have one batch ID for accessing everything, and the system captures all the data. As a result, the MES shows all deviations on dashboards.
This gives them quick changeovers when they need to manufacture drugs quickly, and the flexibility to design new recipes and products when needed.
Find out more about the PlantPAx modern DCS from Rockwell Automation.
Girish Deshmukh vice president of engineering and projects, Dr. Reddy's Laboratories Ltd., Hyderabad, India and Sandeep Redkar, manager of process solutions, Rockwell Automation India Pvt., Ltd., presented "Drug manufacturer achieves operational excellence through plantwide integration," at the Process Solutions User Group (PSUG) in Atlanta, Georgia.
This blog is based off an article from the editors of Control.