(Editor’s Note: At the recent Healthcare Packaging Expo in Las Vegas, numerous new pharmaceutical printing, labeling, identification, and tracking technologies were introduced to meet the needs of manufacturers, packagers, and distributors of drugs entering the supply chain. Pharmaceutical Processing recently asked Tim Kearns of Videojet Technologies Inc. about some of the latest trends and developments in the marketplace.)
Q. Printing technologies are an integral part of the pharmaceutical industry. What are some of the trends you’re seeing in the pharma space?
Tim Kearns: One key trend is the heightened need for intelligent data management. Asynchronous communications allow the printer to send unsolicited information to the line control system. This functionality provides the dual benefits of active notification of a printer event and reduced network traffic, which translates to faster notifications and higher potential throughput. Printers must also be configurable to print both unbuffered, where variable data is received and printed one record at a time, and buffered, where many records are sent to the printer at once but printed only once each.
Q. Describe the various printing and marking technologies and their advantages for pharmaceutical product coding.
Kearns: Thermal inkjet (TIJ) solutions provide high resolution printing of linear bar codes, text, logos, and two-dimensional codes such as GS1 DataMatrix and QR codes. TIJ is generally used to print traceability information on pharmaceutical packaging such as cartons, labels, blister foils, pouches, and barrier materials. Integration versatility, data handling, and serialization help TIJ meet track and trace requirements. TIJ is typically advantageous in terms of throughput for dense coding applications. High-performance TIJ inks provide excellent adhesion and contrast.
Laser marking produces bar codes, including two-dimensional and human readable codes, on pharmaceutical packaging such as cartons, bottles, labels, vials and ampules, tubes, and blister foils. High-contrast, permanent codes help to enable product lifetime track and trace security of pharmaceutical products. Also, lasers can mark multiple adjacent products during indexing. To help ensure proper and safe installation, beam enclosures and fume extraction may be required.
Thermal transfer overprinters (TTO) are integrated into packaging machinery to deliver high-resolution, variable content on labels and flexible packaging such as pouches and barrier materials. With advanced data handling, TTO is ideal for printing variable bar codes. Robust bracketry is a crucial part of the TTO’s integration.
Continuous inkjet systems (CIJ) can be used to print on nearly any package type or product shape and are suited for a wide variety of packaging, including cartons, bottles, labels, vials and ampules, tubes, blister foils, pouches, barrier materials, and stick packs. CIJ technology handles up to five lines of text, linear and other 2D barcodes. While it doesn’t provide the high resolution required for some applications, fast print speeds and a range of inks make CIJ a strong option for many pharmaceutical applications.
For high grade coding downstream on the packaging line, such as on bundles and corrugate cases, print and apply labelers (LPA) automatically print and place labels of various sizes onto packaging. When printing directly onto cases, high resolution inkjet case coders can print accurate, high quality, real-time alphanumeric codes, graphics, and bar codes, including GS1-compliant codes.
Q. What are some of the differences between printing directly onto a drug (such as a pill or tablet) as compared to the packaging? From what you’ve seen, what are the challenges for each?
Kearns: Due to the various barrier materials, there are more options for printing and marking onto packaging surfaces, but pharmaceutical manufacturers must be aware of how inks and laser marking can affect the product inside. For example, extractables and leachables testing may be required to see if ink is causing an adverse effect on the product inside a vial or bottle. When printing directly onto a drug, it is common to pursue extensive stability and reaction testing. Whether coding on the packaging or directly onto a product, any potential risks to the consumer must be evaluated.
Q. What quality checks are important to have in a pharmaceutical printing line? What are your recommendations for ensuring high-quality variable coding?
Kearns: Whenever a code is printed, we typically recommend that an inspection system be placed immediately downstream from the printer. Vision systems for verification can be customized to meet an individual company’s needs, and may vary based on the product being packaged.
Q. Have you found that specific colors or containers do more or less well for legibility and contrast in the pharma industry?
Kearns: The marking and coding industry strives to respond quickly to trends in packaging substrates without compromising product safety or legislative compliance. For instance, while TIJ was traditionally well-suited to print on porous substrates, recent innovations have made it possible to code on a range of non-porous substrates including films, foils, plastics, and coated stocks with certain TIJ printers that use solvent-based fluids. In another example, manufacturers who use HDPE can benefit from advances in UV laser technology. Lasers leverage UV wavelengths to create crisp, indelible black marks on white HDPE, including serial numbers and 2D bar codes.
Whether the requirement is for codes only visible under UV lighting — either for internal traceability or for GS1-compliant DataMatrix codes on cartons or bottles — we work with pharmaceutical manufacturers to find the ideal technology to meet requirements for legibility and contrast.
Q. What are some of the unique serialization/DSCSA challenges (or mistakes) you’re seeing? How can companies ensure they’re prepared for the upcoming deadlines (and avoid/better navigate some of these hurdles)?
Kearns: Advanced coding, serialization and labeling standards like DSCSA require printing technologies that are capable of delivering large amounts of data with consistent readability in small spaces. While the FDA announced a delay in the enforcement of the November 2017 deadline (which requires a unique product identifier to each package and homogenous case of products), manufactures can still be penalized for non-compliance of other DSCSA requirements.
Various coding technologies can help pharmaceutical manufacturers print the required data in formats that can be verified downstream. Pharmaceutical companies need to find the right application partner — one who will help them select and implement a high-quality solution that can provide cost-effective, fast, and reliable coding.
Q. As a whole in the industry, what part of the packaging/printing process still has room to grow? Are there new types of technologies coming down the pipeline that you believe will change the way the pharma industry operates?
Kearns: While internal traceability, diversion control, and anti-counterfeiting are crucial to pharmaceutical manufacturers, the USP and FDA require that vial caps be unprinted. This is where the latest advances in UV fluorescing ink can help. The codes printed with these inks provide excellent read rates under UV illumination sources but are essentially invisible in normal lighting conditions.
An increasing number of manufacturers are taking advantage of this technology to print GS1 DataMatrix and other codes on vial tops while meeting regulation requirements. UV fluorescing inks are available for both CIJ and TIJ printers.
(Tim Kearns is the Sales Manager, Pharma & Medical Devices–NA, at Videojet Technologies Inc.)