Pharma Company Uses Serialization Solution to Produce Life-Saving Medicines

Serialization Solution Helps Pharma Company

Challenge

  • More quickly commission life-saving biotherapeutics line, meet current and evolving regulatory standards

Solutions

Results

  • Reduced packaging rejection from 7% to less than 1%
  • Reduced cycle time by 18-20 days
  • Reduced work in process by 5%

Rockwell Automation delivered a serialization solution that addresses challenges across the spectrum, from automation to MES and ERP to the cloud.

Background

One of Asia’s largest biopharmaceutical companies is driven by the vision to improve access to high-quality, life-saving biotherapeutics. They are working to make medicines more affordable for patients around the world, and are committed to reducing therapy costs for chronic diseases like autoimmune, diabetes, and cancer. 

They needed a turnkey serialization solution with complete track and trace technology to secure and authenticate products across its supply chain. The right investment in the right technology would enable this company to more quickly commission and transport products to those in need.

Challenge

Faced with globalization, intense competition, and strict regulatory guidelines, the customer wanted to optimize its operation.

Successful biotechnology companies are rigorous about their processes and the ability to understand pharma manufacturing operations, process control, validation, and quality improvement. By applying advanced technologies, the company hoped to convert this effort into higher-quality products, less rework, increased profits, and a distinct competitive advantage – all while meeting current and evolving regulatory requirements for multiple countries where these medicines would be used.

Serialization solution helped achieve regulatory compliance.

Solution

This company produces thousands of packages a day and required a solution that could be implemented with little disruption to its production.

Rockwell Automation delivered a serialization solution that addresses challenges across the spectrum, from automation to MES and ERP to the cloud.

The FactoryTalk® ProductionCentre® solution integrates quality management and business analytics with a paperless shop floor and repair execution. This improves operational efficiencies while sustaining regulatory compliance and the highest levels of quality. Rockwell Software® PharmaSuite® offers an innovative approach to serialization, with role-based optimization of each stage of the recipe lifecycle that drives time to results. Open-content architecture paired with an intelligent upgrade engine provided a powerful system designed for growth in both batch and discrete processing.

The solution supports a full, turnkey retrofit solution with an updated Logix-based unit controller that integrates easily into existing systems with preconfigured order channels and EPCIS (Electronic Product Code Information Services) data exports.

Using commercial off-the-shelf (COTS) hardware and software that’s modular, scalable and reusable, the solution accommodates manual packaging lines with a pre-validated, optimized tool that supports manual serialization and aggregation workflow. It meets global standards to enable quicker production restarts with an integrated, open network and communication standards from device (printing, vision and scanning) to the enterprise level.

Able to promote an open platform to interface with existing packaging equipment, the solution accommodates authentication via mobile applications so operators are no longer dependent strictly on scanners.

Adaptable on a global scale to meet current and future regulations, the enhanced system can adapt to more packaging line technologies and production management systems providing a more scalable solution.

Based on Rockwell Automation Integrated Architecture® control systems, with dedicated control network architecture to integrate line serialization equipment, the solution helps minimize interoperability challenges at the plant level and connects seamlessly to the enterprise level and with the supply chain.

PharmaSuite® simplifies integration to PlantPAx®.

Results

The project was delivered by Rockwell Automation with the help of a machine vendor that supports modular extension for any number of aggregation levels with all commissioned serialization and aggregation data that is stored in the plant’s central database. 

Enhanced serialization enabled the company to achieve 100% U.S. Food and Drug Administration (FDA) and European (EU) regulatory compliance. In addition, the solution has reduced:

  • Packaging rejection from 7% to less than 1%
  • Cycle time by 18-20 days
  • Work in process by 5%

The lines are now paperless with end-to-end supply chain traceability.

The results mentioned above are specific to this customer’s use of Rockwell Automation products and services in conjunction with other products. Specific results may vary for other customers.

Integrated Architecture, FactoryTalk, PartnerNetwork, PharmaSuite, ProductionCentre, Rockwell Automation and Rockwell Software are trademarks of Rockwell Automation Inc.

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