Printing Russian Pharma Codes
The US DSCSA delayed deadline has just passed. The EU FMD deadline is just two months ahead. The complex Russian pharmaceutical serialization requirements have been published last summer, causing disruption on pharma packaging lines.
Servicepoint has been working in pharma manufacturing and packaging lines in Russia as well as for exporting to Russia from abroad. We have worked to help our international client to implement Russian serialization in addition to the European one. As the requirements were specified last year with no knowledge on the finalized form of the Russian serialization, we have been working to implement the changes to the system being already installed and validated.
The major issue in Russian pharma serialization is the large amount of data being required in the Data Matrix, leading to large dimensions of the matrix or small dot size. As the standard ink-jet printer head size creates an upper limit on the physical size, getting a GS1-compliant quality printing result with small dot sizes is paramount.
We were able to demonstrate printing a 36×36 Data Matrix with 300 dpi and one printer head and sufficient print quality for further processes, such as pack-by-layer, at a pharma manufacturing line of the client. Developing and implementing a solution was challenging, requiring the top skills and extensive experience of Servicepoint engineers. The data included was (GS1 Application Identifiers) GTIN (01), serial number (21), key (91), and signature (92) — as required by the Russian draft regulation.
This demonstration was of paramount importance, as the use of existing and already implemented EU FMD or US DSCSA compliant serialization solutions facilitates rapid deployment of Russian serialization into pharmaceutical manufacturing. We at Servicepoint are well experienced in updating and upgrading existing pharma serialization systems for new products, markets, new package sizes, or higher capacity.
Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Cyprus. Call us, we can help you!
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