Tracking and Tracing in Small Spaces
By Anastasia Thrift, Managing Editor
Information on pharmaceutical packaging continues to increase, occupying already limited label space. Impending legislation for track and trace codes looms, which means more printing to come. Technology providers are addressing this with tailored solutions based on packaging substrates and serialization necessity.
Domino’s bandage package uses a 2-D Data Matrix code printed via thermal ink jet printing.
FDA is considering adding a serial number to the National Drug Code in its proposed standardized numerical identification guidance. During its period for feedback, several pharmaceutical companies said that the eight-digit serial code wouldn’t suffice, and the California State Boards of Pharmacy suggests alphanumeric codes, perhaps as long as 20 characters.
This potential for extended character codes and the need for Unique Device Identification codes on medical device packaging means the real estate market in packaging is still hot. Today’s printers and coders must meet the demands of several outside forces, and some creative maneuvers are required to maintain aesthetics and readability.
Small-character printing solves some of the issues for the space debate. CSAT America LLC (Louisville, CO) can print at a resolution of 1200 by 1200 DPI, which allows it to achieve a font size as low as 1.5 points.
With limited label space, inserts and outserts become an option to communicate with consumers. At Catalent (Somerset, NJ), customers have cited a need for more information.
“There is definitely a trend toward putting additional information on printed packaging and inserts,” says Victor Dixon, vice president and general manager of printed components. “FDA has mandated that additional information be included and the market trends dictate including larger fonts to be more senior friendly.”
“More and more information has to be squeezed into the same amount of packaging ‘real estate’ or in the case of package inserts, the inserts have to be made larger to accommodate more information,” he continues.
Catalent has made substantial investments in large format printing and folding assets and focused on its infrastructure by training prepress technicians and designers to develop packaging to accommodate the most amount of required information in a senior-friendly and FDA-compliant format.
The CSAT DTS 1200 can print characters as small as 1.5 point font size.
Emerging government regulations such as California’s e-pedigree and potential FDA serial numerical identifiers call for unique package coding. Applying variable information could require a 2-D bar code and human-readable text.
Bob Neagle, business unit manager at Videojet Technologies’ brand protection solutions group (Wood Dale, IL), bases printing solutions for his clients on their substrates, and focuses efforts on the increasing demand for unique code printing. He encourages digital printing, as opposed to hot stamp or embossing.
“The change from printing static human readable data to printing variable 2-D bar codes can affect print quality and throughput on the packaging line if not properly prepared for,” Neagle says. “Traditional nondigital contact coders are not able to meet this requirement.”
Pharmaceutical companies must meet current production speeds while applying the impending codes. Many pharmaceutical companies have suggested using GS1’s Global Trade Identification Number (GTIN), which can include application identifiers for lot codes and unique serial numbers.
“In the case of ink-based coding, the technology must offer fluids that are applicable to the packaging material and must produce a repeatedly high-quality bar code because it is essential that codes are readable throughout the supply chain,” Neagle says. “A camera system tied to a packaging line controller can ensure that codes are readable and contain the proper information.”
Pharmaceutical manufacturers rely on standard printing technology options, depending their needs. Continuous ink-jet (CIJ) printers offer fluids that will adhere to the substrate and can be used for HDPE bottles and folding cartons; thermal ink-jet (TIJ) has fast print speeds (over laser coders) and works for folding cartons or any other uncoated space. Either ink-jet solution will suffice for blisters. For coding on vial caps, laser coders and CIJ printers both are viable options. Thermal ink jet printers do not offer appropriate fluids for this application.
Domino suggests printing Data Matrix. The company says new proposed code formats, however, are much larger and Data Matrix codes need better mechanical handling and process control than normal. Domino promotes its holistic project approach to offer coding device and vision system choices for the best standards, algorithms, and connectivity.
“The key point to note is that any system is only as good as its worst part!” says Craig Stobie, global pharmaceutical business manager, Domino.
Videojet’s bottle-printed serialization code contains both human-readable characters and a 2-D bar code.
Domino’s latest machine to help take on this need is its A-Series Plus Duo. The CIJ printer features twin jets in a single print head, doubling the amount of lines created at the same rate of single-jet printing. Packagers can print multiple lines of code for traceability requirements by adding an extra printer to the production line and the complexity of tracking the code from two printers without having to reduce line speed. The company says the printer offers the same benefits of its A-Series plus printers, including the patented sealed nozzle for reliable start-ups and built-in connectivity.
CSAT works to accommodate unique device ID codes with its licensed software and unique “Hash” functions. With this system, data can be encrypted using a source code that ties each printed code to a unique identifier only known to the owner of the software.
“This algorithmic code makes it virtually impossible to copy and would be tied into a track and trace system by the end-user to determine authenticity,” says Joe Buono, CSAT sales manager.
The company also incorporates new technologies to meet growing needs. “The benefit of using digital printing technology means that the system can be adapted to meet new regulatory standards by simply updating the software,” Buono says.
Catalent works with customers for coding and has developed solutions around packagers’ multiple demands.
“Serialized printing has its own set of challenges especially in an environment where there has been no clear standard established,” Dixon says. “The biggest issue relates back to the different standards and how to accomodate a variety of requirements from many different customers. In many cases, variable data printing with 2-D codes and the use of digital printing techniques are the customer’s preferred method. Other times, the customer prefers to have the serial code printed via ink jet or even laser ablation.” Catalent is looking at various solutions that will allow us the flexibility required to meet our diversified customers’ needs.