Bringing MES to medical device packaging

Stirling Medical Innovations is implementing a Manufacturing Execution System (MES) that Stirling project leader Colin Boyd calls "the way of the future."

At the May 20 Packaging Automation Forum in Schaumburg, IL, Boyd will talk about the benefits this implementation brings to Stirling's packaging operations.

The specific medical device involved here is a brand new cardiovascular test strip similar to those used by diabetics. But instead of testing a diabetic's blood sugar levels, this product tests for the presence of a "biomarker" confirming that the patient has had a heart attack. Stirling, whose parent company is Inverness Medical Innovations out of Waltham, MA, makes the test strips, coats them with the necessary reagent, and packages them in primary pouches and secondary cartons in its Stirling, Scotland, facility.

The key deliverable here is a comprehensive Device History Record—from incoming raw materials through manufacturing through packaging and labeling--that's recorded automatically and electronically rather than on a clipboard, says Boyd. He also expects to see a streamlined label reconciliation routine and, because the MES software constantly displays to operators precisely what a batch order requires them to do, he anticipates a 20% reduction in manufacturing time per batch.

The MES software selected by Stirling was the Medial Device Suite from Camstar.

"The goal is to remove any chance of human error where data entry is concerned," says Boyd. An added benefit is that the process model for each batch—including, of course, packaging—is "enforced" by the MES program. "Product can't advance from one stage to another unless all required parameters and process criteria are satisfactorily met. So at the end of the manufacturing and packaging process, product release is practically instantaneous. And should there be a recall, we scan a bar code on the pouch or carton and instantly see a full history of that product. We can pinpoint what went wrong and when it went wrong in minutes, a task that might have taken days in a paper-based system."

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