By Robert Rack
Back in July 2002, FDA sought input on the use of bar codes for future labeling requirements for drugs. I advocated for the use of serialized Data Matrix codes to effectively identify unique items, thereby improving traceability and eliminating counterfeits. Due to multiple technical advantages, I believed that Data Matrix should become the symbology of choice over Reduced Space Symbology (now known as GS1 DataBar). More than a decade later, it clearly has. Data Matrix ECC-200 and QR codes will dominate for the foreseeable future. The real estate requirement of many packages are so small that only Data Matrix can work.
Having implemented the original versions of Data Matrix codes for more than 60 systems for Barr Labs and Biocraft (now both part of Teva) in 1993 and 1994, we have seen the code evolve so that the current Data Matrix ECC-200 is more space efficient and much easier to implement, print, and decode, even with substantial code damage.
Data Matrix on medical devices will become standard. The ability to use Data Matrix for either printing, laser ablation marking, or mechanical marking by methods like dot peening ensure that it will remain the dominant code for medical devices unless somebody creates both a more space efficient code as well as one that has adequate error correction to deal with real-world print drop out and print quality isues. And in hospitals, far more information may be encoded in either Data Matrix or QR codes to lessen errors as well as ensure patient privacy and proper dispensing of medication and set up of test and diagnostic equipment.
How did we get here?
My company implemented a true electronic pedigree solution in 2001. We built a system for tracking at the tablet level what was then and may still be the most tightly controlled drug, mifepristone, better known as RU-486. The system we built then made it easy to know where every pill was, every intermediate package, and every shipping case. Both Code 128 and Data Matrix codes were used on every level of packaging. If a single tablet was retained for testing or any other purpose, we knew it. If a tablet was missing, we knew it. The intermediate package’s information was stored in a database and also within a Data Matrix code that was printed on the outside label. This was also done at the shipping case level.
The way that we built it, even if the database were to be destroyed, the entire database could be rebuilt just by scanning the information encoded within the labels on the shipping case or the intermediate packages.
In 2008, we built a system that made implementation of e-pedigree printing and full label inspection possible at speeds as high as 500 ft/m. Speed was limited only by which printing technology our customers wanted to use.
Today, technology continues to advance. We’ve installed laser systems for printing the requisite Data Matrix codes and associated serialized human readable data at rates as high as 500 labels per minute. Imagers now dominate over lasers as the reading system of choice because of cost and the fact that there are no moving parts to wear out on an imager.
I believe that full label inspection for thermal-transfer printers can now become commonplace for a turnkey cost of less than $10,000 fully integrated on labels up to 5.4 in. wide. The line scan technology used here is currently limited to a maximum rate of 13.7 in. per second, but that will keep up with virtually all thermal transfer printers, and it could be used on many low to medium speed labelers as well. Why not have full label inspection for all human readable text, graphics, serialized data match, and ISO grading of all bar codes on label at a sub $10,000 price installed – because now you can. This became possible and was first implemented successfully in 2012.
Combining this line scan inspection technology with a full-color label printer that prints at 4-6 in. per second, you can now print the entire label and fully inspect labels up to 5.4 in. wide with the total system cost less than $13,000. Another system can print and inspect labels up to 8.5 in. wide for less than $18,000. These offerings allow for small runs that are very cost effective and can be printed just in time. These became available at the end of 2012.
We will see even more symbology changes in the near future. We’ll see more use of the rectangular data matrix codes that are available since they are better suited to bottle applications if the data requirements are close. Far too many packaging people think that there are only square Data Matrix codes.
Don’t be square!
Robert Rack can be reached at email@example.com.