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• Innothera helps reduce manual Batch Error Records by 400%

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Innothera helps reduce manual Batch Error Records by 400%

and slashes review times by 50% using Rockwell Automation MES solution.

Challenge Implementing a new Electronic Batch Records system to: • Reduce errors • Improve review and approval times • Improve quality and assurance • Speed time to market Solution • Rockwell Automation’s Life Sciences Solution Delivery team’s experience and project execution • A modular, standardised approach Benefits • Batch record errors cut by 400% • Review times reduced by 50% • Faster time to market • More flexible control of systems • Improved quality, traceability and rigour

The main experience of Innothera Group lies in the treatment of venous diseases and in venous compression with the manufacture of compression and support hose. The company continues to expand developing its range of pharmaceutical products to help improve the quality of life. Established in 1920, the company today has a turnover of 125M Euros, mainly to export markets.

As a small but growing life sciences company, Innothera was looking for a better Manufacturing Execution System to help improve compliance and performance at its production site in Chouzy, France. Its existing system had become obsolete and was no longer being maintained. The company’s priority was to create an electronic batch records process, improving its right-first-time statistics, leading to a reduction in review time and a more efficient operation.

Innothera, led by Plant Director Bruno Bidault, created a User Requirement Specification focusing on the need for an electronic batch records process and then invited six companies to respond. Innothera was impressed by Rockwell Automation’s response, which most closely met its needs. Based on the response, Rockwell Automation’s extensive project management experience and its global delivery capabilities, Innothera decided to move forward with the Rockwell Automation RS PMX EBR MES – the Electronic Batch Record module.“Rockwell Automation was best able to offer us a standardized, modular solution which would require very little adaptation. This was important to us because we had experienced problems with maintaining adapted solutions in the past and did not want to have this problem again in the future. We also wanted a solution which could be implemented one step at a time, at our own pace,” explained Bruno.

Looking to the future, the company was also interested in the additional modules, such as supervision, warehouse management, dispensing and skills development, that could be added to the solution overtime.

Solution and implementation
Among the function sets of the RS PMX MES suite, RS PMX EBR MES delivered all Innothera needed for an electronic data handling process. The comprehensive automated documentation, electronic signature, and online plausibility check functions, allowed Innothera to greatly reduce costly paper production and archiving.

The Electronic Batch Record (EBR) module is used to author, create and use the recipes for each product. It makes sure that only the approved recipe version can be used, delivers step enforcement through batch record, provides a tracking and audit trail for the production process and triggers alarms when processes are incorrectly completed.

Working alongside Rockwell Automation’s Solution Delivery team, Innothera appointed two people to manage the implementation. Initially the team worked alongside the Innothera staff to programme the system but the knowledge transfer was quickly carried out.


Bruno explained that in some areas, such as Quality Assurance, Innothera had to change the way that it worked to use the new system and although not easy at first, the benefits soon shone through.

Today the electronic batch record system is being used by 83 users, in 13 workshops and across 15 different specialty areas of pharmaceutical production.

Benefits
Innothera has seen the benefits of the new system almost immediately. The number of incorrect batch records has been reduced by four times because human errors have been drastically reduced. Global review times have also been halved resulting in faster stock approval and release.

“The Rockwell Automation solution has added real rigour to our global processes,” said Bruno. “In the past, software solutions have been seen as a cost without benefits but the benefits are very real and measurable with this solution. We are not a large Life Sciences company but the RS PMX MES solution is perfect for our business. The standardised, modular solution really made a difference in terms of time, costs and maintenance requirements in the future.”

Moving forward, Innothera is now continuing to roll-out the Rockwell Automation RS PMX MES suite across the business, beginning with the dispensing and supervision modules, followed by the warehouse and packaging modules both in 2010.

For more information, please e-mail us at: info_at@ra.rockwell.com with ref: Innothera