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Pharmaceuticals labeling for manufacturers

In accordance with the federal law dated December 27, 17 No. 425-FZ, starting from January 1, 2020, legal entities that manufacture, store, import into the Russian Federation, dispense, sell, transfer, use and destroy pharmaceuticals will have to ensure that information on pharmaceuticals has been entered into the system for monitoring the pharmaceutical’s movement for medical use.

We have developed several solutions especially for pharmaceuticals manufacturers in collaboration with industrial printers and machine vision systems manufacturers. The solutions are a hardware and software complex VEKAS-ACS, fully complying with the Federal Law FZ №425 and the Chestniy Znak requirements for the pharmaceutical industry.

Solutions fall into two categories – automatic and manual systems.

Automatic systems enable full automatisation of marking, reading codes, control, etc. Designed for high-performance lines.

Manual systems are the lightest solutions that allow, using a computer, handheld barcode scanner or hand-fed autoscanner and software, to label, control, and then enter the information into a database.

Pharmaceuticals production technological process

List of control objects

The pharmaceuticals accounting system is designed for piecewise quantitative accounting of manufactured products, accounting for products as part of blocks and boxes. DataMatrix codes are applied to the secondary level of packaging, as well as to the primary level for pharmaceutical products for which secondary packaging is not provided. The group (transport) packaging is labeled with a marking code in the form of a linear bar code in Code 128 format in accordance with GOST ISO/IEC 15417-2013.

The following objects and procedures are subject to registration:


  • single packages (packs, vials, bottles, tubes, etc.) of finished products;
  • packaging in boxes (boxes);
  • boxes in pallets.

Accounting automation object

The object – an automatic system of piece accounting (ACS PC) has three control points for finished products: a single product zone, a box formation zone and a pallet formation zone. The product passes each of the areas, the finished product is automatically recorded.

Single product area

When the product passes the unit product zone, the following technological operations are carried out:

  • applying a code on the packaging by a DataMatrix laser printer;
  • controlling the application of the DataMatrix code using a verification scanner;
  • emergency line stop in case of multiple error of DataMatrix code verification.

Box forming area

The following technological operations take place in the box formation area:

  • placing several packages in one box;
  • reading DataMatrix codes of all packages in one box;
  • controlling the codes of all packages of the box read by DataMatrix;
  • Generating a label in the software with the DataMatrix code for the box;
  • sending a task to print a label to a thermal transfer printer;
  • aggregating printed DataMatrix box code with DataMatrix packages codes;
  • rejecting boxes with errors in reading or checking the DataMatrix package codes.

Pallet forming area

The following technological operations take place in the pallet formation area:

  • adding DataMatrix box codes to the list of formed pallets;
  • stacking boxes on a pallet;
  • generating a label for a pallet in software;
  • sending a task to print a label with a pallet code to a thermal transfer printer;
  • DataMatrix aggregation of box codes and printed pallet code.

System’s main functions

  • Obtaining codes from the Pharmaceuticals movement monitoring information system;
  • Transferring DataMatrix package codes to the printer;
  • Applying DataMatrix code to the package;
  • Controlling the application of the DataMatrix code to the package;
  • Emergency line stop upon detection of packages with unreadable codes;
  • Reading DataMatrix codes of packages from the box;
  • Generating DataMatrix code and accompanying human-readable information on the box label;
  • Reading the box code printed on the DataMatrix label;
  • Associating the DataMatrix code of the box with the DataMatrix codes of the packages inside;
  • Rejecting boxes with unreadable DataMatrix package codes;
  • Rejecting boxes in case of inconsistency of the DataMatrix codes of the packages with the codes obtained;
  • Controlling the correspondence of the number of boxes in the pallet to the specified value;
  • Generating a barcode and related human-readable information on the pallet label;
  • Reading the pallet barcode printed on the label;
  • Associating the pallet barcode with the DataMatrix codes of the boxes inside
  • Determining the rejection reason, informing the line operator of necessity to perform regulated actions;
  • Maintaining a database and receiving statistical reports (all actions and events);
  • Forming and storing archive recipes for a technological line and selecting the current one;
  • Generating report files with any given structure and transferring over the network;
  • Ability to import/export data with company’s data systems according to a separately agreed-to algorithm;
  • User-friendly human-machine interface with different access levels.

We provide service support for our solutions.


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