Russia's New Track & Trace Regulations
Know How

Russia's New Track & Trace Regulations

Know How

New Challenges for Pharmaceutical Manufacturers and how to Solve Them

The new Russian rules for serialization and aggregation are out, and the deadlines have been set. There is not much time between now and the initial deadline for manufacturers to bring themselves into compliance – and even less time to begin addressing the challenges of these new requirements. We will focus specifically on the challenges for the product packaging site – the moment where the product is assigned its serial number and cryptographic code.

The Basics

Like all other serialization requirements, the core requirement is the same: each individually packaged unit needs to have a serial number assigned to it, which is then recorded and transmitted to the Russian government. The difference is one of complexity – while the European FMD or the US DSCSA regulations have similar requirements, there are two differences that complicate matters for manufacturers:

  1. The requirement for printing a cryptographic code onto each secondary package.
  2. A much more thorough recording of a package's movement through the supply chain.

Packaging Challenges

The second difference is less of a concern for packaging sites – they fall under the responsibility of Level 4 and Level 5 systems, and include a whopping 36 compliance events that need to be recorded, a far cry from the EU FMD's 7 – but the addition of a crypto code to the product packaging poses a significant set of challenges. Namely:

  1. Crypto codes need to be requested from a webservice (if the packaging step occurs outside the Russian Federation) or from encryption hardware (if packaging occurs inside the Russian Federation).
  2. Crypto codes must be printed on each secondary package. The codes are 88 characters long, and the included crypto key is an additional 4 characters long. This effectively quadruples the required capacity of the data matrix code
  3. The data matrix code needs to be readable by inspection and aggregation cameras.
  4. The system must report the use of the Crypto Code to a centralized information database.

These are significant challenges, but meeting them is a simple enough matter of getting the right equipment and implementing the right processes. For the most part, existing production lines will need to make some changes – but the nature of those changes depends on the manufacturer's decision.

Requesting and Handling Crypto Codes

This is the first new step in the serialization process, which will require the level 2 and level 3 software to be upgraded. Essentially, site-level management software will need a connector and workflow added in order to request the Crypto Codes and keys from the Russian-run webservice. It is also possible that this step would be handled by a Level 5 cloud provider, in which case the level 2 and 3 software would need to have a different workflow. Manufacturers should check with their level 5 cloud providers to see which option they will need to implement.

Printing and Verifying the Crypto Code

The printing of the serialization information is, perhaps, the largest challenge. In essence, the addition of the crypto code drastically increases the amount of data that needs to be encoded into the data matrix code. Normally, the required information can be contained in a 22x22 module format – this includes mandatory serialization information along with optional information such as lot code and expiration date. In order to add the new required crypto code, the format needs to increase to 44x44 modules. Sacrificing the optional information will still require a module format of 40x40. This is the first decision manufacturers need to make: reduce the size of each module to half of the original size and thus maintain the size of the printed code, or double the printed size of the code while maintaining the size of the modules.

Increasing the size of the printed code carries a few significant challenges. For starters, there may not be room on the packaging to print a code of that size, necessitating a redesign of the product packaging. At the very least, it is likely that some changes to the layout of the package will need to be made in order to accommodate the new size. In addition, printing a larger code will require a second printhead, precisely aligned to ensure a seamless matrix code. Many of the printers installed in PCE systems, for example, already feature two printheads side by side. For those, an alignment plate will be available to ensure a seamless print. Other systems will require upgrading with a second printhead and alignment plate. The end result allows existing cameras to read the new codes, although their position may need to be adjusted in order to increase the field of view enough to read the larger codes.

The other option, reducing the module size, carries its own set of challenges. The artwork and packaging can remain unaltered, but whether or not the existing printer is capable of printing at the reduced module size needs to be considered. Barcodes must be able to achieve a quality grade of C or better in order to be compliant with Russia's regulations, placing further focus on printer abilities.

Depending on the printer model and packaging material, it may not be possible to reduce module sizes without replacing the printer or packaging material. In addition, older models of smart camera may not be able to process the larger amount of information, making it necessary to replace them with a newer model. Regardless of which option is ultimately chosen, all existing equipment will need to be tested and, potentially, replaced.

Aggregating Crypto Codes

As the Russian regulations mandate aggregation of all codes, it is necessary to have a high resolution camera or smart camera capable of reading and aggregating the codes together. Most manufacturers are already aggregating, and fortunately, most high resolution cameras should be able to easily adapt to a larger physical code size – although it may be necessary to adjust the field of view. If manufacturers elect to go with a smaller module size instead of larger code size, it may be necessary to replace the existing camera or adjust its field of view to reliably read the information. If smart cameras are utilized for aggregation, the same considerations as for print inspections apply. Like everything else, the existing hardware needs to be tested before a final decision is made.

Reporting Consumed Crypto Codes

As with requesting the codes, the specific process of contacting the Russian central information system can either involve the level 2 or 3 system reporting the crypto code use directly to the Russian service, or it can involve the level 2 or 3 system passing information to the level 4 or level 5 interface, where it is then reported. It depends on the capabilities of the level 4 or 5 interfaces.

How METTLER TOLEDO can Help

To address these challenges, METTLER TOLEDO PCE has developed the necessary software upgrades to our PLM and PSM software to enable either direct communication with the Russian webservice or communication with Level 5 cloud providers, making it easy to obtain the necessary crypto codes. For data export and reporting, we can report back to the Level 5 system, or provide a direct connection to the Russian webservice. For manufacturers with multiple production lines which might not all be producing Russia-bound products, upgrading PSM for Russia does not make it incompatible with lines not producing products for Russian use – meaning only the lines which need crypto code functionality will need to upgrade their versions of PLM.

In addition, we are ready to provide an evaluation of your current printer and camera setup to provide advice on which option would work best for your particular production setup. Bear in mind that you will need to talk to your printer provider as well – the final recommendation on printer capabilities should ultimately come from them. We can also provide replacement cameras for any existing METTLER TOLEDO PCE cameras already on your production lines, should it be necessary.

This is all with the usual on-site evaluation, software and IT consultation, and complete project management that you have come to expect from METTLER TOLEDO. Time is of the essence, so get in touch with us to start the evaluation process now! 

 
 
 
 
 
 
 
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