Peter Sarvey Director of Business Development WLS (a ProMach Product Brand)
What is the importance of labeling in “track and trace?”
Sarvey: Labeling plays a key role in track & trace as the serial number, 2D data matrix, and/or other unique product and batch identifi ers reside on the label. The variable data, unique product and batch identifi ers, are printed and inspected on the labeler, so the integrity of the label tracking system and product tracking system must be robust. The merging of the label, being the “license plate”, and the product, being the “VIN”, takes place on the labeler. If the label or product is deemed unacceptable by the vision inspection system(s), the labeler will take care to reject the bad label, the bad product, or the labeled product. The label and product tracking system reports all of the accepted and rejected units associated with the batch or lot. All of this makes the labeler one of, if not the, most important pieces of the track & trace solution. Maybe I’m biased as a pharmaceutical labeler OEM... but there’s no denying the importance of a robust label and product tracking system with the implementation of track & trace.
How has the technology improved over the past few years?
Sarvey: Print technology has improved along with vision inspection technology, each allowing for faster throughput with reduced rejects when printing, inspecting, and applying labels for a serialized track & trace solution. There are now many different print technologies that produce high-quality human readable text and high-grade barcodes at very high speeds. Additionally, vision inspection algorithms are more robust than ever, eliminating false rejects, eliminating the need for operator interference, and increasing throughput for the packaging line.
Where is it headed?
Sarvey: Being able to print reliably at higher speeds-- coupled with robust vision inspection systems that can inspect and provide results at higher speeds--pushes us to produce labelers that can operate at speeds that seemed unique just a few years ago. The entire machine control system on the labeler has improved with the need for high- speed synchronized motion, I/O, and Gigabit communication that can match the capabilities of the printer(s), camera(s), and data management servers.
Better, faster technology provides the capability for AI-like operation. The labeler can detect if the wrong label stock is loaded, if the wrong product is fed, or the incorrect print or inspection template is selected. All of these pieces are connected digitally to alert the operator of an issue quickly, without wasting time or product.
How does regulation (like DSCSA) impact labeling practices?
Sarvey: It’s a big deal! Regulations like DSCSA are the reason why almost every labeler that we produce includes a variable data label printer with a vision inspection system. As I mentioned previously, the need to print brings the need to inspect, which brings the need to reject via the label and product tracking system. In addition to label and product tracking on the labeler, track & trace requires data exchange and network communication. All of this enhances the capabilities and robustness of the labeler, and increases the capital equipment cost and operational complexity for the manufacturer.
What can companies do to get up to speed with “best practices” as well as being compliant with regs like DSCSA?
Sarvey: I always suggest speaking with industry professionals who have experience implementing track & trace. The manufactures should speak with their labeler partners, printer and camera suppliers, and serialization database management providers. Ask questions about what has worked, what hasn’t worked and be well read on the current guidelines for DSCSA, GMP, etc.
To what extent have oral solid dose manufacturers incorporated “smart” labeling like QR codes, to provide consumers with more information?
Sarvey: I have seen QR Codes, printed on the label, used for customer engagement, product information, and authentication to prevent counterfeits and/or redirects. Customer engagement via QR Codes is a great way to track who, when, and where a product is being used. Product information that is found through a QR Code allows the manufacturer to simplify the design of the label and, in some cases, eliminate the need for a multipage label--reducing the label cost and simplifying the label application (e.g. labeler). QR Codes provide the opportunity for manufacturers to update information after a product has been labeled and shipped, since the referenced website is maintained in realtime, unlike a pre-printed label. QR codes, like serial numbers, can be used for product authentication while the geolocation of the device that scans the QR Code can be used by the manufacturer to track redirect, when a product that is packaged and sold in one country ends up in another country without the knowledge of the manufacturer.
Anything else manufacturers need to know about labeling that I’ve forgotten?
Sarvey: Selecting the right labeler is extremely important to the manufacturer’s packaging operations. The labeler should have a robust tracking system with tight synchronization between all of the critical technologies like printing, inspecting, applying, rejecting, recipe management, and network/database connectivity. The labeler should also be sized for future throughput, not just today’s throughput. I know capital equipment purchases are a big deal, so try and do it once with a look to the future, rather than being solely focused on today’s needs.