Wyeth Pharmaceuticals takes paper out of batch processes; puts MES in

Wyeth Pharmaceuticals is transforming itself based on the need for operational excellence. The Collegeville, Pa.-based company views integrated systems and standard processes across its research and manufacturing facilities as a good way to drive down costs and improve quality.

Already today, Wyeth makes use of what enterprise and execution systems have to offer. SAP is the enterprise system of record in North America, with ongoing deployment in Europe.

By year’s end, Wyeth expects to have 15 instances of its Labware laboratory information management system (LIMS) implemented, and seven instances of a Rockwell Automation manufacturing execution system (MES).

Getting rid of paper-based, manual systems will eliminate time-consuming errors while enforcing consistent process performance and cutting cycle times.

“If you eliminate mistakes, people focus on what they’re supposed to instead of investigating errors,” says Jeff Schaaf, senior director of manufacturing and technology transfer process for Wyeth Pharmaceuticals. “Inventory, costs, and cycle times will come down.”

Setting the boundaries

At the start of each deployment, “Critical emphasis is put on the ‘to-be’ process state,” says Schaaf. “We map out the ‘as-is’ process, and then apply lean techniques to get things properly aligned. [The key] is getting everyone at each site to agree.”

It’s also important to establish boundaries—i.e., which systems own what data to prevent confusing duplication. “We use each system for what it’s best at,” Schaaf says. That is, ERP owns the materials; LIMS owns the material potency and batch dispatching; and MES controls the master batch record and process data.

“The overall benefit of standardization is speed of deployment,” in enacting multiplant production scenarios, says Jim Ricigliano, Wyeth’s director of process excellence. “It makes everything repeatable. Once you clear the smoke away, most sites aren’t really different.”

At Wyeth, automated systems prove invaluable in enforcing standard processes. “The system verifies that sequence steps are performed in the proper order. It verifies data has been entered properly,” Ricigliano says.

For Wyeth, errors that required timely investigation for a batch to be certified have fallen precipitously.

“If a batch process from time of weighing of materials to pressed tablet takes 12 days, but it takes you 60 to 70 days to get the batch out of the plant—that tells you that you have problems. With an automated system, you can wring tremendous value out by eliminating errors inherent to manual systems,” says Ricigliano.

Ending errors

Prior to the LIMS go-live, Wyeth’s error rate was between 300 and 450 defects per million. In less than two months, errors effectively flat-lined near zero. Before implementing MES, weekly batch record errors ranged between 13 and 33. Within two weeks of the MES go-live, it too essentially flatlined at zero, while the average number of batches actually increased.

Wyeth engineered a 100-percent reduction in batch record errors, a 50-percent reduction in labor utilization in specific work centers, and a 30-percent reduction in batch documentation review time.

“With standard systems, you’re always looking at the process, trying to achieve the ‘golden batch’,” says Ricigliano. “Using paper records would take days or weeks. With the automated system, it’s a matter of hours, enabling you to repeat that performance and get to that golden batch faster.”

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