Critical Thinking For Critical Environments

“Amsterdam, We Have a Problem.”

BD Diagnostics is a medical technology company that sells a broad range of medical supplies, devices, laboratory equipment, and diagnostic products. BD was having issues with a gamma radiation/sterilization indicator label they were purchasing from a company in the Netherlands.

Great Expectations

BD came to us with a number of problems they were encountering with their gamma radiation indicator labels, hoping CleanMark could provide the same product with reduced lead times. Because the product they were using was manufactured in the Netherlands, BD was dealing with significant price fluctuations.

The labels BD was using required refrigeration for storage prior to use, because temperature variations would cause inconsistent label performance. BD wondered if it was possible to eliminate the need for refrigeration all together.
Long and wildly fluctuating lead times from their supplier in the Netherlands created production planning issues and delays.

“As with any project, the first thing we have to do is figure out what the customer expects the product to do. In this case, we talked to them a lot about their application and their performance expectations, and we uncovered a range of issues a successful solution would need to address.”
— Lane Kagey, COO, CleanMark

A Gamma Ray of Hope

CleanMark tried three different iterations before landing on a solution BD really liked—one they continue to use today. The first approach was to look for a better ink. We worked with a variety of ink suppliers and experimented with the process. BD’s first impression was that the ink still didn’t change color dramatically enough when exposed to gamma radiation.

The color intensity changes gradually with gamma radiation exposure beginning at 10kGy with a light orange; at 15kGy the indicator is a burnt orange, and at 25kGy maximum color change is achieved at brick red.

We tried a new ink supplier and worked with them to ensure the radiating label change would be more recognizable. This supplier provided a different ink that changed from green to purple. On this pass, BD felt the change was too dramatic and would require re-educating their customers.

After a third attempt, we were able to provide BD with a label that satisfied their color requirements. Plus, the new label had no temperature restrictions and therefore didn’t require refrigeration. But outsourcing the production and adding another link in the supply chain was not the most efficient or cost-effective method for BD.

We determined that if we just bought stock indicator material directly from our supplier, and laminated it onto a blank label in our high-speed roll equipment, we'd solve the problem.

Almost—it turned out the manufacturing process being used by our supplier was resulting in a lot of process variation in the color or density of the color. We recommended a different manufacturing process, and the outcome was consistent, producing a higher quality product that delighted BD.

Color Me Resolved

In the end, with CleanMark Labels taking a collaborative approach, all parties involved benefitted from the process. BD, to this day, now offers superior gamma radiation/sterilization indicator labels to their customers that don’t require refrigeration, and shorter lead times that resulted in a win-win-win situation!