Bagging a New Code

In mid-2002, Baxter announced its pledge to bar code all of its 1000 injectable and IV-solution products by early 2003. To accomplish this for its IV bags, Baxter developed a new technique that prints the bar code as a reverse image. In other words, Baxter prints the spaces. The bars of a traditional black-and-white bar code are now represented by transparent spaces. The laser light passes through the bag while the reflective spaces reflect the light, just as black ink printed on a white label does on traditional bar codes.

Baxter chose to use a linear bar code rather than Reduced Space Symbology (RSS) or Composite symbology. 

"Because the installed base of commercially available scanners can currently only read linear bar codes, going with linear bar codes allows the greatest number of potential users to take advantage of Baxter's solution," says a spokesperson for Baxter. Because the bar codes can be printed on the IV bags as they are manufactured, Baxter can include the lot number and expiration date in a second linear code underneath the bar coded National Drug Code. "By including lot number and expiration date, point-of-care systems can warn if a product has expired or if a recall has been issued before a patient receives the product. Users can also benefit from operational efficiencies as they can be alerted to products that are nearing expiration and that should be used soon. Baxter is the first company to include lot and expiration date on flexible IV bags," says the spokesperson. 

Thanks to being able to include the NDC, lot number, and expiration, printing and applying a secondary label for the IV bags is now unnecessary, further reducing the chance of errors. And because the bar code is high resolution, it can be scanned through protective translucent overwraps. 

Webscan's Spitz acknowledges that many scanners today are so good that they can read some bar codes that receive an ANSI "F" grade. "However, there is no guarantee that all scanners can read them. The chance of a no read or even a misread increases with decreased print-quality grades. The printing process should be optimized to produce the best quality codes possible on a consistent basis."

Spitz adds that any irregular form of the surface can influence the grade, and that when a verifier is used for quality control, those conditions should be considered. "For example, verifying the code in its final form is good for determining information about that particular code. Many companies will inspect products that they receive in this way. However, to determine the condition of a printing process in general, one may decide to verify the codes as they are produced at an earlier stage of production."

Davis says that RSS/Composite codes can be printed with high ANSI grades with the current printer technology. "But the entire process from art design and printing plate manufacturing to printing must be in control to achieve consistent print quality results. During plate making, exacting ISO specifications must be met and verifications reports should be supplied with the printing plates. A bar code file master verifier should be used to measure the plate-ready film and other optical inspection devices should be used to measure the printing plate. Press proofs should be pulled from the finished plate and be verified to ISO print quality specifications. In addition, the individual components of the printing process must be controlled. These include substrate, ink, printer, anilox roller, doctor blade, printing plate, sealing plate/roll, perforator, die-cutter, etc. These elements should be verified regardless of whether a bar code is printed, and unit-dose bar coding requires even tighter control."

Some companies are considering in-line bar code readers and optical character verification (OCV) systems that can verify both completeness and readability of the text and bar code, as well as grade the bar code, says Soporowski. "This grading ensures that what was printed in-line is of consistent quality to allow subsequent scannability for the end-user."

And in-line verification takes time, says Peter Buczynsky, president of Micron PharmaWorks (Tampa, FL). "In-line verification of RSS codes on blister machines is the greatest challenge today, due to image resolution for large formats and processing and decoding time required. It takes anywhere from less than 20 milliseconds for stacked codes to much longer when dealing with Composite codes, especially when computing ANSI grading," he explains. "Checking the codes after they have undergone sealing deformations provides the most accurate inspections, but can also generate the most headaches."
 
But there is a big need for 100% in-line inspection, he says. So Micron PharmaWorks is currently working with Microscan Systems Inc. (Renton, WA) to evaluate Microscan's Quadrus EZ fixed-mount CCD-based cameras for in-line inspection. According to Microscan, these smart cameras can be used to read multiple symbology types on the same machine with just one bar code reader. For his particular application, Buczynsky needed to stagger several cameras across the web. 

Depending on product orientation, multiple units may not be necessary, reports Bob Taplett, senior applications engineering manager. "Patented image processing software features can expand the unit's field of view, enabling Quadrus EZ to capture all of the symbols on a blister pack in one read cycle," he explains. 

Webscan is also working on an in-line version of its TruCheck bar code verifier system, Spitz reports. He envisions companies using these systems on packaging lines to ensure that the printer is optimized at all times.

Micron Pharmaworks is also working with IPD, the intelligent products division of machine vision manufacturer Coreco Imaging, in developing an in-line inspection system for reading RSS. The new inspection system features IPD's NetSight general-purpose machine vision system, which now supports customized software for decoding RSS-14 symbology.

DVT Corp. (Norcross, GA) is also working on solutions. Using its FrameWork software, DVT's SmartImage Sensor can read all linear versions of RSS. The next version of FrameWork 2.6, due out in April, will be able to read Composite codes, reports Michael Williams, director of communications. A free software upgrade will be available through the firm's Web site at www.dvtsensors.com. 

RAISING THE BAR

Solutions for selecting, printing, and verifying unit-dose bar codes are still in the works, but experts don't recommend waiting for all the kinks to be worked out by others. Jim Umbdenstock suggests talking with printing plate providers, printing system providers, and other equipment providers now so you won't be caught off guard when FDA does finalize its rule. "Prepare yourself by studying all your options now, then make your move after FDA's announcement."

Wright of PIPS furthers this recommendation. He notes that many expect FDA to institute a two-phase implementation period, one for encoding unit-dose NDCs and a later one for lot and expiry dates. He advises companies to encode the GTIN (NDC with packaging level indicator), lot code, and expiration date during the first phase-in period, space permitting. "Why spend time and money first on bar coding just the NDC and then redesign a second time for the lot and date? Besides, scanning those secondary data elements can save lives by preventing the administration of recalled and expired drugs."