Ensuring that the plant floor receives, processes and documents the correct ingredients is crucial to efficiency, which is why expanding French producer Innothera decided to automate data handling
French pharmaceutical group Innothera has cut its manual batch error records by 400% and slashed review times by 50% following the installation of a new Manufacturing Execution System (MES). The main area of drug development for the expanding Innothera Group lies in the treatment of venous diseases and in the manufacture of compression and support hose, but it also produces tablet-based osteoporosis treatments and laxatives. The company currently has a turnover of around Euro 125m.
As a small but growing company, Innothera was looking for a better MES 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.
The company, 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. Rockwell Automation's response most closely met its needs and Innothera decided to move forward with the automation specialist's electronic batch record module RS PMX EBR MES.
"Rockwell Automation was best able to offer us a standardised, modular solution that 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 that could be implemented one step at a time, at our own pace," explains Bidault.
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.
Among the function sets of the RS PMX MES suite, the system delivered everything that Innothera needed for an electronic data handling process. The comprehensive automated documentation, electronic signature and online plausibility check functions allowed Innothera to 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.
Innothera appointed two people to manage the implementation, who initially worked alongside the Rockwell Automation team when programming the system, and the knowledge transfer was quickly carried out.
In some areas such as Quality Assurance, Innothera had to change the way that it worked to use the new system, says Bidault, and although not easy at first, the benefits soon became apparent.
Today the electronic batch record system is being applied by 83 users, in 13 workshops and across 15 different specialist areas of pharma production. The company has seen the benefits of the new system almost immediately. The number of incorrect batch records has been reduced four-fold because human errors have been drastically cut. 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," says Bidault. "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."
Innothera is now rolling out the RS PMX MES suite across the business, beginning with modules for dispensing and supervision in 2009, and for warehouse and packaging in 2010.
