preserializacion
Article

The pre-serialization procedure, step by step

The forthcoming entry into force of the European Directive 62/2011 on the 9th February 2019 concerning medicinal products for human use, aims the prevention of the entry into the legal supply chain of falsified medicinal products. In order to prevent falsification, every folding carton containing prescription medications and those in  risk of falsification, have to include an unique identifier (UI) that enables pack identification and an anti-tampering device (ATD) allowing the verification of whether a pack has been opened or tampered with.

By means of the 12th July 2017 informative note, a third party, non-titular of the market authorisation, is approved to do packaging pre-serialization procedures.

Pre-serialization is the process of printing a variable and unique code on the packaging.

Nekicesa, as an authorised and experienced company in packaging pre-serialization for over 6 years, ease, align and streamline each step needed for medicinal products code printing.

Those steps are:

  1. The artwork adaptation
  2. Code generation and files transfer
  3. Packaging manufacturing. Printing variable codes.
  4. Packaging delivery and documentation

infografia-preserializacion-en
 

This process will be explained in detail throughout the following weeks. Our first approach is to the artwork adaptation, detailing how the folding cartons’ designs should be modified to include the serialized code.

The artwork adaptation

Updating all packaging designs (artwork) can be a great challenge for laboratories. It consumes  time and resources as well as involves a number of internal and external approval procedures.

The question arising is: is it necessary to change every artwork? and, to what extent do we need to modify them? In this decision, the lab should take into consideration different factors:

   A) How codes are going to be printed on the packaging?

Packaging will be supplied pre-serialized . In this case, the code is printed on flat packaging, allowing to print in almost any place of the surface. This provides complete design freedom to place the code in any part of the folding carton.

Serializing on the packing lines makes it more difficult to print the code in the folding carton’s printing area. First of all because the print head will be placed on one side of the line, difficulting mobility and secondly, as the packaging will not be flat, it limits print spin. Therefore all folding cartons  should place the coding space in the same area. As a result, it will affect the layout design, that will need to be changed in order to keep clear that area.

   B) Is there already an empty area designated for the code?

Most of the pharma packaging already have this empty space, the one designated for batching. This area, currently intended for placing the batch number and expiration date, will be substituted by the serialized code in most cases.

This blank space needs to have ideally a minimum size of 1 centimeter height and 3 centimeters width (so it can include the human readable legend.)

In most cases, “batch number” and “expiration dates” will need to be removed from the artwork as those (or their abbreviations BAT and EXP) are already printed along with the new code.

   C) Is it necessary to leave a free varnish area?

Depending on the code’s printing technology it will be needed or not. In Nekicesa we recommend to leave a free varnish area, so the laboratory can have all artworks unified no matter the printing technology used.
In Nekicesa Packaging, besides pharma packaging pre-serialization services, we have now  created a branch of the company in charge of packaging design, “Global by Nekicesa”, able to implement all artwork adaptations for serialization procedures.