Life sciences companies have the dual task of maintaining flexible production lines to respond to changing market demands and cost-effectively managing compliance requirements. Rockwell Automation continues to expand the flexibility of its Rockwell Software PharmaSuite v5.2 manufacturing execution system (MES) to help manufacturers respond to these challenges and execute electronic batch records in new and more efficient ways. The PharmaSuite v5.2 system includes improved agility and production control, as well as native integration with FactoryTalk Historian software and the OSIsoft PI System to help pharmaceutical and biotech companies optimise production, improve reporting and shorten development time.
Martin Dittmer, PharmaSuite product manager, Rockwell Automation, says: “We’re aiming to set new performance standards for MES with the PharmaSuite v5.2 system. Empowering operators with agility and production control, without sacrificing quality, delivers improved time to results. The PharmaSuite v5.2 system decreases the time required to produce, review and release each batch, and speeds processes across production areas or individual lines for more efficient recipe execution.”
Recipe elements can be executed in parallel by multiple shop floor operators with PharmaSuite v5.2. On the production line, recipe tasks can be freely moved between electronic batch recording stations or can be fixed to a specific station by recipe design. This iteration allows operators to define and control the level of execution freedom on the shop floor and increases the efficiency of electronic batch recording.
In addition, PharmaSuite v5.2 supports dynamic registration of devices like industrial laptops or tablets to a production line station to enable worker mobility and collaboration in a more flexible, but still secure manner.
The newest version of PharmaSuite also includes native integration with FactoryTalk Historian and the OSIsoft PI System to increase insight into production by gathering and archiving actionable information into one deliverable. Historian integration automates the process of collecting historical data, developing trend charts and attaching this information to the batch record. This reduces human error so operators can focus on production rather than reporting.
Ted Gorrie, Vice President of Enterprise Sales, OSIsoft, says: “We look forwarding to expanding our long-standing alliance with Rockwell Automation to simplify MES-historian integration because we understand the importance of accurate, historical data in making smarter decisions, and clearly and easily communicating historical production quality to regulators. Integration with the PharmaSuite system increases the value of the investment manufacturers have already made in our historian and MES systems.”
PharmaSuite v5.2 also has the ability to export production orders and electronic batch records for long-term archival using PDF and B2MML standards. With this, regulatory requirements for batch record retention can be efficiently supported. Increased execution efficiency and completeness of batch records will help manufacturers to further reduce overall production costs and accelerate the return on investment.
To learn more about the PharmaSuite v5.2 manufacturing execution system, please visit www.ra.rockwell.com.