Since my last essay about the Russia Crypto-Code (a.k.a., Crypto-Tail) (see “New Direction For Pharma Serialization In The Russian Federation”), Russia has published little of value in document form about the requirements or the technology. I have heard rumors that the pilots conducted with the Crypto-Code have failed. Interestingly, according to the Center for Research in Perspective Technologies (CRPT), the Russian 50-50 public-private company now under contract with the government there to define and implement the technology, those same pilots were a smashing success. I am skeptical of that reported success, but let’s take a look at some of the details they have provided.
Back in July everyone was expecting four new documents to be published by the end of August. I’m now aware that two were actually published. One which simply officially extended the original government pilot through the end of next year, and the other identified CRPT as the official government contractor that will take over the conduct of the “experiment” on behalf of the Russian Federal Tax Service for barcoding medical products (drugs) (referred to as “MDLP”). CRPT’s government contract did not begin until November 1, 2018 so it might take them some time to get set-up and publishing additional documents. It may also require more government decrees before they can proceed further.
By far, the best resource for information currently available widely is this webinar from CRPT. Fortunately it is in English. Originally recorded on October 18, 2018 by Anton Kharitonov of CRPT, this webinar recording seems to confirm almost everything I wasn’t sure about in my earlier essay. By the way, if you understand the Russian language, there are other webinars on CRPT’s website here. Is information from CRPT to be taken as official? I don’t know, but they seem to think it is.
In the webinar, Mr. Kharitonov explains the anticipated deadline of July 1, 2019 for labeling—with the crypto-code in a datamatrix barcode—a small number of drugs aimed at seven rare diseases/conditions (nosologies). The only other anticipated deadline so far is January 1, 2020 for all drugs to be labeled with the crypto-code.
You can find a number of technical documents regarding the pilot here but at this moment they are all in Russian. You can use Google Translate to translate sections, or whole documents, but they will be far from perfect, and may be unusable as a result. I would offer my own Google-Translate-based versions of some of these but Mr. Kharitonov says on the video that they planned to offer their own translations back in October. Seems like a waste of time to do it myself if their official translations are imminent.
In the webinar recording, Mr. Kharitonov explains some of the lessons CRPT has learned for maximizing the speed and print quality of the resulting datamatrix barcode from testing with various printer manufacturers. He says that they have successful achieved a stable 0.5% reject rate for ink jet technology (laser technology is better) printing the 4 quadrant datamatrix (40×40 modules) in the space of 9×9, 10×10 or 12×12 millimeters (their goal is 0.2% rejection, which still seems like a lot of rejects to me). That’s a pretty dense datamatrix (for an likely example of a Russian datamatrix containing a crypto-code, see “How To Accept Manual Entry Of Drug Unique Identifiers”). In fact, he says that the printers can print those sizes at a rate of 300 packs per minute, with the resulting barcodes meeting Grades “C” or higher.
He says it took them several months of tweaking to achieve those results. Among other things, they found that the printers had to be capable of 600 dpi and the printer’s “pixelization mode” had to be “ON”. Interestingly, he said that the line speed wasn’t limited by the capabilities of the printers in their tests. The things that limited the rate were the verification cameras. They could not decode the Russian crypto-code-containing datamatrix fast enough, so higher performance cameras will be necessary. He did not identify any equipment by name or model.
I’ve known about this webinar recording for more than a month but I had too many other topics to write about. It’s pretty long, and even when Mr. Kharitonov signs off, keep watching because he comes back and spends another 25 minutes responding to questions from the audience. Some of the answers offer additional information. Most just repeat information from the main presentation.
Recently, I heard about an industry association that has requested CRPT to consider cutting the length of the crypto-code to half its current length to help print and verification speeds as well improve the reject rate and lower the package real estate taken up by the barcode. I’m not sure they can reach their reliability goals with just 44 characters, but if they can, then it’s a good idea.
Here is a very well written article by Evgeny Belov and Mikhail Khazanchuk in the September issue of CIS GMP News. It provides an excellent description of the Crypto-Code and the issues surrounding it.
As with most governments, Russia is behind schedule to provide the official information necessary for widespread implementation. This compresses the amount of time left over for industry to implement, test and deploy the necessary software, hardware and SOPs. In a reasonable world, this should result in extending the deadlines. Do you think it will this time?
Dirk.
