Pharmaceutical Label Printing: Ensuring Compliance

While pharmaceutical label printing is big business—2014 estimates fall in the neighborhood of $14 billion—working in this complex industry is not for everyone. The pharma label printing industry, with its strict compliance and absolute quality control demand—will only get more demanding.

Traditional pharmaceutical coding on labels required only the lot number and expiration date. As part of the Drug Supply Chain Security Act (DSCSA), passed to overhaul track and trace rules and increase accuracy of supply chain information, and set for enactment in 2017, “the U.S. Food and Drug Administration (FDA) will soon require pharmaceutical manufacturers to code products with unique, serialized data in human and machine-readable formats,” said Casey Robertson, Videojet Product Manager, TIJ & TTO.

The most common machine-readable format is the two-dimensional DataMatrix code.

The goal of the DSCSA is to minimize liability and costs due to recall, and deter counterfeiting and diversion while maintaining the integrity of pharmaceutical brands, Robertson added.

The DSCSA’s specific requirements regarding coding create a “a daunting task, and with a deadline initially some time in the future, many don’t realize until it is too late what needs to be done to comply,” explained Mark Schaffer, Pharmaceutical Business Development Manager, North America at Domino Amjet.

With the new regulations, machines must be able to produce a machine readable data matrix code that contains four or five different lines to include lot number, expiration date, Global Trade ID number, and unique serial numbers.

With more information required on the label, coding is a more-time consuming process. “The new coding requirements also take up a lot more real estate on the label,” said Schaffer. “The issue then becomes fitting the code on the label, which may require a change in label graphics. If you change the graphics, depending on what is required, you may need FDA approval for the changes.”

The pharma industry demands the highest quality variable coding. Printing and marking equipment is critical to DSCSA compliance, as it must ensure that pharmaceutical products have crisp, high-resolution codes that do not fade or distort. Legibility and contrast are non-negotiable when it comes to regulatory and traceability coding and labeling. At the same time, marking and labeling solutions must also facilitate line productivity and seamless integration for today’s competitive environment.

“Due to these demands, safety and traceability remain significant challenges. The new regulations including serialization requirements, high quality standards, and supply chain complexity – all continue to put increased demands on PSPs production lines,” Roberston reported. “Videojet understands these challenges and delivers consistently reliable print and label solutions that perform at a high level to help exceed production requirements.”

Implementing efficient and effective variable data marking technology within the manufacturing process is one method manufacturers can help ensure an effective traceability solution.

The following are the printing and marking equipment best suited to meet DSCSA requirements, said Roberston.

• Thermal Inkjet (TIJ) printers are often used to print codes on cartons, flexible packages, labels, films, and foils. The advantages of TIJ printing are clear: delivering high-quality codes at fast product-line speeds. Taller, complex codes can be printed as fast as simple, alphanumeric codes, which is a helpful reassurance for packaging engineers who anticipate adding code content in the future for additional DSCSA requirements.
• Laser Marking Systems offer the benefit of permanent codes directly on bottles, labels, cartons, blister foils, and a wide variety of other pharmaceutical packaging. Since lasers alter the product surface, codes made with laser technology have the highest code permanence, making them difficult to remove or falsify. Laser marking offers a restricted color palette, but recent innovation has introduced ultraviolet laser sources that can create black marks on common pharmaceutical substrates such as white HDPE bottles.
• Thermal Transfer Overprinting (TTO) has been engineered to work specifically on flexible substrates including pouches, barrier materials and labels. Common applications include thermoformed packaging, tray sealing machines, and label applicators. It is an ideal option for delivering reliable, high-resolution codes with a variety of integration alternatives.

While Domino does offer all three types of printing technology, it’s predominant technology for the pharmaceutical marking is laser etching, said Schaffer. “Our D-Series laser etches those labels delivering permanence, consistency, and accuracy,” he said.

“Our technology ensures that the provided label structure is created properly,” explained Schaffer. “The laser coding technology needs to deliver the coding quickly, and it has to very repeatable; that is crucial to this kind of coding. The coding can’t impact line efficiency and you also don’t want the product rejected because the coding is not accurate.”

Domino has pioneered the use of sealed CO2 laser coding systems. Its laser coding portfolio comprises the state of the art D-Series i-Tech CO2 scribing lasers, and the F220i fibre laser. Its D-Series plus, for example, is a highly versatile range of industrial scribing lasers designed to provide high quality codes across a wide range of production speeds.

Videojet offers serialization-ready printers designed to help ensure clear, accurate coding for regulatory and supply chain requirements. In addition, Videojet’s broad portfolio of coding technologies helps satisfy a vast array of integration and production needs.

Videojet’s solutions include:

• The Wolke m600 oem Thermal Inkjet Printer, which combines integration versatility with powerful data handling and global track and trace capabilities. It is specifically designed to meet serialization requirements in pharmaceutical packaging applications.
• The Videojet Imprints Track & Trace Solution, an end-to-end, production-floor suite of hardware, software, and services. The solution fingerprints brands to powerfully address specific threats of counterfeiting, diversion and recall. Its software generates unique codes to print on product packaging and maintains transaction data about products as they progress through the supply chain.
• The Videojet 7810 UV Laser Marking System is an ideal solution for high-quality, permanent traceability codes on pharmaceutical packaging. The 7810 UV laser produces high-contrast codes on hard-to-mark plastics, including high-density polyethylene (HDPE).

Along with specific coding requirements, there are a host of other challenges pharma label manufacturers face, including proper integration into the packaging line, data handling between serialization systems and printers, light-fastness in relation to product lifecycle needs so inks don’t fade, and water resistance in cold chain environments.

“Though the DSCSA serialization deadline isn’t until 2017, pharmaceutical manufacturers looking to gain a competitive advantage over other firms should begin their adoption plan now,” said Robertson. “A coding and marking specialist with knowledge of all three recommended printing technologies can help evaluate the specific printing needs to bring a manufacturer in line with the DSCSA requirements and assess anticipated needs for the future.”

Both Robertson and Schaffer agree that pharmaceutical label printers should be thinking proactively about high-resolution coding solutions that are robust enough for accurate product identification and traceability through their full supply chain.

“It’s critical to take a proactive position vs. a reactive position,” Schaffer said. “As the finer nuances of label graphics change or the label structures change, there is a trickle-down effect in your world.”

There are potentially massive implications in logistics in changing labels and in packaging requirements; modifications in replacing label equipment could cost thousands of dollars, noted Schaffer.
Not all label converters understand the implications. “They assume they have a labeler and labels, some exiting coding technology, and that they are fine,” he added.

One situation that occurs often is that label converters will often wait to the last minute to think about the process. “All of a sudden they realize the labels aren’t compatible or that they can’t be compliant by the date,” said Schaffer.

“We find we do a tremendous amount of work implementing pharma serialization equipment to be compliant with regulations,” he added.

One of the biggest mistakes made is that many involved in pharma label approach it as a linear process. “It isn’t,” said Schaffer. “You have to look at it as a holistic process; there is no starting or finishing point. Everything is affected by everything else.”

Each phase of the process impacts every other phase, from the labels themselves, to the label graphics, to how you apply the graphics to how you apply coding.

Planning how you will implement the new label regulations, and including all stakeholders and vendors in the planning, if your best chance for success, said Schaffer.