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    On-Pack coding meets medical device pack needs
A Texas based medical device manufacturer utilizes six in-line thermal transfer printers with traversing heads to apply bar codes to medical device lidstock, offering significant savings as the company gains efficiencies, improves scannability. Mounted on tf/f/s systems, the programmable units streamline the coding process and reduce downtime.

Protective, transparent, exacting and stackable, the medical device packages thermoformed, filled and sealed by the company, a global distributor of medical products, are now clearly coded by a series of in-line, programmable thermal transfer printers from Bell-Mark that have streamlined the medical device packaging operation in only four months time.

The Texas location, one of three divisions of the company, believes in the direct approach, especially where direct, in-line printing of its medical device packages is concerned. That philosophy is proving itself: Just months into operation with its new thermal transfer printers, the company already has seen a return on its nearly $250,000 equipment investment. "It was an easy choice to make," notes a director of manufacturing. "We're starting to convert a lot of packages over to thermal transfer printing for additional product and package categories."

The company, which complies with ISO 9001 guidelines, manufactures and packages patient monitoring and vascular access components, including a diverse line of single-use, sterile disposable medical instruments and surgical devices such as intravenous tubing sets, transducers, catheters and guidewires. Packaging comprises assorted flexible and rigid thermoformed containers currently in seven sizes. Distribution is worldwide; the majority of domestically shipped packs are transported to hospitals by United Parcel Service.

Each rigid or flexible thermoformed tray is lidded with a peelable stock incorporating DuPont's Tyvek® spunbonded polyolefin. The lidstock is preprinted with the company's name, address, contents information and other mandatory label copy. Until installation of the EasyPrint® printers, variable product information was imprinted either by dot matrix or ink-roller; extensive variable data couldn't be included.

The new EasyPrint traversing model thermal transfer printers are used to print up to 10 lines of variable information and bar codes, which satisfies customer and legislative compliance requirements, and the printers save importantly vs. other coding and labeling methods. The company purchased six of the EasyPrint® printers early this year as turnkey units through Multivac, installing them on four horizontal thermoform/fill/seal machines including Multivac R5000's and Tetra-Laval's Tiromed Models CSVA 390L and 390L. Two of the tf/f/s machines are equipped with one printer each because of larger pack sizes they run. These print one row of one to four packs per row. The other two tf/f/s machines each require two printers because they can cycle two rows of three to six packs at a time. The packaging machines average an output of 30 packs per minute.

Coding packages either 3-, 4- or 6- up and moving on a linear rail, the compact stepper motor-driven direct thermal traversing printers electronically print the variable information on the package lidding in a 2- inch wide print area. Though the lidding is still preprintd with nonvariable product copy, with more than 2000 stockkeeping units and the volume of products produced, the company opted for an alternative to input the variable information and the codes. "What really prompted the addition of these printers was governmental requirements, but the codes have also become an industry standard," says the company spokesperson. "We've looked at other printing methods, but thermal transfer was the best option. It was cost prohibitive for us to fully preprint the package or apply labels with so many skus. To achieve a good, clear bar code on the lidding that would meet all of the ANSI (American National Standards Institute) standards is somewhat difficult, however."

With large package volumes, he points out that the company needed a quick-change, programmable way to satisfy the coding requirements, as well as make copy changes and other revisions. "Nothing else was economically viable for this type of rollstock lidding," he notes. "We have to deliver a top quality, clear code. We searched for about a year, but couldn't find another printer like this anywhere."

Multiline Data

In addition to printing a 16-digit Code 128 bar code, Bell-Mark's EasyPrint units can generate up to 10 lines of human-readable data, including a lot number, expiration date and product description on multiple packages across the web. Operating with Bell-Mark's Windows™ based creation software, the EasyPrint employs a single print-head that automatically moves across a bar, which eliminates the need for multiple printheads. Run by programmable logic controller, the unit saves the company substantially in inventorying precoded webstock or labels, the spokesperson says, as the PLC's E-Prom cartridge needs no in-field programming.

The company sees these and other attributes defining the machinery, including reliability, code and character consistency and clarity, drop in downtime due to changeovers and quick, responsive service: "Printing crisp, clear, scannable codes and other data directly onto the certain types of lidding can be somewhat difficult because the substrate isn't always smooth and flat. Some substrates tend to make ink spread out. Bell-Mark has come up with printers that provide a direct thermal print ribbon with very good results. That's really what we were looking for. And the printers are versatile, being Windows based. They produce very clear, quality print."

Changeover time drops

But the drop in downtime due to changeovers from one print message, product and package type to another is dramatic: "It used to take us at least 45 minutes to make a changeover before on some of our former printing dies," the company spokesperson says. "That could mean losing two or three hours a day of machine time. But we're gaing that time back now. Changes on the EasyPrint are a snap, less than 5 minutes, a tremendous savings." Switching codes, lot numbers, product descriptions or other print layouts is a matter of recalling a new product code in a memory card resident in EasyPrint's controller and sending that information to the printer, a 15 second task that requires no ink cleanup, setup or downtime. Print formats are recalled using the design software. Product specific codes can also be printed in real time, a key advantage the spokesperson says his firm didn't have earlier. The company can program each printer with specific number of print images, bar codes and other details, storing and selecting the data from the EasyPrint memory card or downloading the data from a nearby PC.

The printhead is conveniently mounted on a traversing bar that allows the unit to code as many as 30 packs across a moving web. This, according to the spokesperson, is critical for medical device applications where packages can be very narrow, and can be formed in as many as 36 cavities up. This lowers the costs over other imprinters and eliminates the need for additional printheads, additional roll changes and extra printhead changes, he says. "And the coding equipment helps the company better meets customers' varied needs for tracking and scanning bar coded product and inventories." Printing packs with 5 to 10 lines of type at a character resolution of 300 dots per inch, Bell-Mark's EasyPrint printers are able to reach speeds up to 300 mm per second, ample for the company's needs, according to the spokesperson.

The company thermoforms the trays in a Class 100,000 controlled enviroment. Depending on the product, forming material is either Rexam Medical Packaging's .0080- inch DuPont Surlyn® ionomer / polyethylene flexible film or 24-ga blue tinted rigid polyvinyl chloride from VPI Mirrex. Lidding, from Perfecseal, is DuPont's 80-ga Tyvek 1073B, flexo-printed in one or two colors. Both forming web and lidstock is supplied on rolls a bit more than 15 inches wide. The base web of the packs is formed as the webstock unwinds from the master roll and drapes over the forming cavities within each machine. Filling performed on the machines' loading beds is currently done by hand, but the spokesperson says that could change on some of the production lines.

Coding takes place just before the filled packages are perimeter-heat sealed. As the lidstock unwinds over rollers and is placed over the open, filled cavities of the formed packages, the tf/f/s system halts and the thermal transfer printhead then traverses across the lidstock to apply the messages and bar code before the lidstock meets the sealing die. The packs are typically printed in character sizes 1/8 inch high. Once sealed, the containers move to the cutting station where the continuous web of packs is punch-cut and seperated into individual containers as the machine indexes the packages through a set of roller blades. Next, the packs exit the thermoformer and a quality inspection check is made to the components, for such things as print accuracy, code quality, particulate, seal integrity and missing components before the packs exit the clean room and convey to the case-packing department.

There, the finished packs are case-packed by hand in counts of 10 to 25. The 175# test, C-flute corrugated shippers are provided by East Texas Container. Tape-sealed cases are then palletized and the entire six-foot, 42 x 48 inch pallet load is transferred into an 8 pallet bulk ethylene oxide (EtO) sterilizing chamber. "Code durability is crucial during sterilizing," the spokesperson says. "Some inks, depending on compostion, can possibly smear. Our codes come out clear and legible."

Cost saving ribbon

The company's staff says it also likes the automatic ribbon advance system, which delivers more than 22,400 print images per ribbon yet minimizes ribbon usage. "These printers don't have a constant feed of ribbon," the spokesperson says. "The ribbon saving feature allows them to only print the width of an image and stop; other systems can use four inches' worth of ribbon for a four inch wide image. EasyPrint starts and stops the ribbon between eack package, so just that one feature saves probably 20 percent or more in ribbon costs."

Contact Bell-Mark for more information
As more product developments continue to come to the fore at the company, the spokesperson says he's ordering additional printers. "There's at least one other thermoforming machine coming to this plant from another division and we'll put one or two printers on it. We're very happy with the printers." the company has recently networked the printers from a single PC so that when necessary, they can imprint a particular bar code and description for a given medical kit product on containers running on mulitple lines. The printer also accomodates foreign languages, which will come in handy; the company's just about to begin coding the packs with multilingual copy in several languages and will also soon move to radio-frequency scanning.

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