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Print-apply labeling is the right prescription for medical test kit cartons

dade pharma labelingBecause technicians in hospital laboratories around the world rely on bar-coded information to help them perform critical diagnostic testing, those bar codes can be nothing less than perfect.

Dade Behring Chemistry Systems in Newark, DE, faces this bar coding challenge every day in the labeling of its products. So when its carton label printer-applicator could no longer efficiently and consistently meet the company’s strict quality and production criteria, Dade Behring sought out a cure for its labeling ailments.

The result of the 1997 merger of Dade International with the Behring Diagnostics unit of Hoechst AG of Germany, Dade Behring Chemistry Systems is a leading developer of products and systems for in vitro diagnostic testing, primarily tablet and liquid reagents used to perform both routine clinical chemistry tests and complex immunodiagnostic analyses. A company with sales of approximately $1.5 billion and 8,700 employees, Dade Behring distributes its reagents directly to hospitals for use in their laboratories.

The Problem
Dade Behring started using bar codes in 1986 with the commercial release of the company’s Dimension® clinical chemistry system, an advanced system that enables laboratories to perform a wide range of tests that previously required multiple work stations. Dade Behring manufactures reagent combinations for 65 different test methods for the Dimension system and packages the test cartridges in either four- or eight-pak cartons.

The cartons are preprinted with the company name, product description and the type of test method that the cartridges contain. The compact carton also includes instructions for storing and using the test in five different languages to accommodate Dade Behring’s international distribution. Lastly, a critical Code 39 bar code is preprinted on the carton’s top.

Adding to this information, Dade Behring prints and applies to each carton a pressure-sensitive label that contains a lot number, expiration date and a Code 128 bar code with a specially encoded link character. This "secondary" bar code links to the preprinted "primary" bar code as a check system to ensure that the proper test has been packaged in its designated carton. The 1.75"W x 3.25"L label is applied to the top and side of the carton.

"We label our cartons on two sides so hospital technicians have two opportunities to identify the tests when they’re piled up in their laboratory refrigerators," explains Jim Feeley, assisstant engineer for Dade Behring. The lot number and expiration date are repeated in both locations, while the bar code only appears on the top portion of the label.

Dade Behring had been using a print-apply system that was anchored to a stand and rolled up to the short conveyor line on which the cartons were running. Labels were printed, partially applied, then wrapped around the second carton panel. Located in a busy production area, the free-standing printer-applicator was often jarred by passing operators. This caused inconsistent label placement and poor label registration.

"Placement of the carton label is critical," says Feeley. "We have limited real estate to get that bar code on without encroaching on the quiet zone of the primary bar code."

Additionally, the printer-applicator was regularly outputting poor print quality, but with multiple vendors involved in the application, Dade Behring could not determine if the problems were attributable to the hardware or the media supplies.

"We had different vendors for the printer-applicator, for the software, for the ribbons and for the labels," states Curtis Yates, production manager for Dade Behring’s chemistry group. "When problems arose, there was a lot of finger pointing and we had trouble getting service."

Dade Behring was looking for a more reliable labeling system: one that would provide consistent application and improved print quality, plus operate with a friendlier software package. The company also wanted one vendor that would assume total accountability for the entire operation.

Dade Behring also required that its new print-apply system integrate a more efficient method of handling poorly bar coded products. With its original system, Dade Behring incorporated a laser scanner after the printer-applicator to read both the primary and secondary bar codes. If a bar code was unreadable, or if the two didn’t match, the production line stopped. Dade Behring wanted a rejection system that would allow production to continue.

"We don’t sell to consumers, we sell to hospitals, and we wanted to marry ourselves with a vendor that could handle what we do," remarks Yates, whose labeling demands encompass high, continuous volumes, as well as HIBCC and FDA guidelines.

Dade Behring found its labeling partner in bar code labeling specialists Weber Marking Systems, Inc., Arlington Heights, IL.

"We quickly learned that Weber is used to servicing big accounts, and we were comfortable with that," says Yates.

Weber worked with Dade Behring to install a fully integrated print-apply labeling system that upgrades the firm’s labeling and production capabilities. The set-up includes a 10-foot custom conveyor with Weber’s Label-Aire® Model 2138 high-speed printer-applicator, a wipe-down station, an automatic rejection area, and Weber’s exclusive Windows labeling software.

The Hardware Solution
Dade Behring’s growing production volume creates a need for nearly two million cartons to be labeled per year. The company operates three shifts, five days per week to output roughly 40,000 cartons each week.

Weber’s Model 2138 printer-applicator incorporates a high-speed thermal-transfer print engine with a patented tamp-blow label applicator that simultaneously prints and applies labels at a throughput rate of up to 5.0" per second, easily handling Dade Behring’s production requirement of up to 20 cartons per minute.

After reagent cartridges are filled, labeled and individually wrapped (see additional sIory on Dade's cartridge labeling application), an operator packs the cartridges in four- or eight-pak cartons and manually places the cartons onto the custom conveyor leading to the printer-applicator.

An electronic eye signals the printer-applicator of the product’s arrival and triggers the applicator pad, already staged with a printed label, toward the product. The pad extends to within .25" of the product and blows the label onto the carton top without contact. By combining precise tamp-blow technology with an immovable printer-applicator, Dade Behring is assured that each label is applied with consistent accuracy to ±0.03".

The Model 2138 is positioned on the conveyor so that it applies only half of the label on the carton top, leaving the other half flagging off the end until it reaches the wipe-down station. Here, a brush gently and securely affixes the rest of the label onto the side panel.

The next integrated station along the conveyor line is an Allen Bradley Adapta Scan laser scanner that Dade Behring used with its previous system. Driven by a back-end software program that Dade Behring developed, this scanner reads both the primary and secondary bar codes on the top of each carton as they pass by.

Through the software and a "learn switch," the scanner is programmed to recognize whether both bar codes on each carton match up and whether all the cartons in the lot match the first carton of the run.

Bar codes that pass the test continue down the conveyor, where they are packaged in large shipping cases for delivery to Dade Behring’s warehouse. If a bar code fails the scan, the rejection arm extends and pushes the product off the conveyor into a bin. The rejection device immediately returns to its position without interfering with production.

"I don’t worry about our carton labeling anymore, and I could not say that before we installed the Weber system," says Yates. "When our cartons come off this line, we are sure that the content of the bar code is correct and that the right reagents are being shipped in the right cartons."

This system is responsible for 75 percent of the reagent cartridge labeling. Dade Behring added another Model 2138 from Weber for a second production line that assists with operation during one shift each day. This line also incorporates a wipe-down station and scanning device, but no rejection station.

Dade Behring is planning the addition of a third reagent production line by 1999 and intends on incorporating an identical Weber system with the rejection station.

The Software Solution
The Model 2138 operates with Weber’s exclusive Legitronic® labeling software, a Windows-based package that enables operators to format, print and store label data with ease.

"The Legitronic software is very easy to use," comments Feeley. "It does exactly what we need it to do, and we’ve asked it to do some odd things."

Dade Behring’s application truly takes advantage of the software’s features, including its formatting, file management, batch control and interfacing capabilities.

To initiate the printer-applicator, an operator uses a nearby PC to type in a single data string. Legi For Windows automatically disperses the typed information into the appropriate fields of the label format. This is an improvement over Dade Behring’s previous software, which required the manual entry of three data strings, greatly increasing the chance for errors.

In addition to the hardware and software, Weber completes Dade Behring’s bar coding system by supplying custom labels and compatible thermal-transfer ribbons. Weber manufactures Dade Behring’s labels on a film release liner, which is an upgrade from Dade Behring’s original paper liner. The sturdier film liner cuts down on dust and eliminates downtime from web breaks. Dust may have played a role in the failure of Dade Behring’s original labeling system, Feeley says.

"From hardware to service to materials, the whole system has been a lifesaver," asserts Feeley. "We only have one number to call if there’s a problem. Weber is our partner in making sure our labeling system stays operational."

The new system – which Feeley says paid for itself within a year – meets Dade Behring’s other labeling goals, as well. It provides better, consistent label placement and improved print quality. This translates into a reduction in the number of rejected, wasted labels and cartons.

The new operation also eliminates 80 labor hours per week, as it converts Dade Behring’s labeling operation from a batch printing mode to more of an on-demand method.

"Originally, the labeling operation was completed in batches, one lot at a time," explains Yates. "Often, to keep up with production requirements, we would start running two new products while we were packaging a third. This created a risk of product mix."

The fully integrated printer-applicator, however, permits smooth, continuous production, eliminating the risk of product mix while greatly reducing downtime. "Now our only downtime occurs when we have to change the ribbon in the printer-applicator," says Yates.

Dade Behring has experienced no quality or process problems since the installation of its new labeling system, which leads Jim Feeley and Curits Yates to believe that Weber’s print-apply system is just what the doctor ordered.

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