Serialization systems and European legislation: MG2 Track & Trace

It is time to serialize for the European drug market.
In fact, since last February the 9th it is compulsory to comply with the standards required by the FMD Directive (Falsified Medicines Directive).

Serialization is a central topic for the pharmaceutical market. In fact, if on the one side it affects both the economic aspect and the safety issues regarding patients’ health, on the other side EU wants to give an answer by imposing the EMVS, the European Medicines Verification System.
In 2017, the commercial value of counterfeit drugs has reached important figures with almost 600 million euro of goods confiscated in Customs. A phenomenon which the European Union has decided to stop, by requiring its Member States to modernize production lines with serialization systems, thus enabling product traceability.

Track & Trace system for cartons model ACE CT/400

At the head of the process, there is the EMVO – European Medicine Verification Organization – together with its local organizations in the member states which, with different compliance dates, are obliged to implement the new system, thus integrating it with its own control procedures.

The design of serialization systems is a mission which has involved MG2 for several years by allowing the development of systems in compliance with the international standards in terms of traceability.
ACE Track & Trace systems indeed make it possible to carry out both the marking and the verification of cartons, bottles and bundled products in the end of line.
The system first prints a unique identification code on each element, then it verifies the code to reject non-compliant elements.
Speed can vary according to the machine version, reaching up to 400 cases per minute of the model ACE CT/400.

All the machines of the ACE series can also be equipped with Tamper Evident units, which allow to verify that the packaging is intact through the application of labels or stickers, and they can be integrated with weight control units.

The aggregation can be carried out by using either model GSL10 horizontal case packer or model GTL30 vertical case packer, together with models B30 and GRP palletisers, which complete the line and the automatic traceability process.

These machines are designed to be integrated with different systems such as the vision systems able to read serial codes printed on each product, the printing management systems, the application and verification of a label on the box, thus automatically rejecting non-compliant products.

 

ACE CT/400 detail –
laser printing and code reading area

Last but not least, MG2 is a a perfect partner who guarantees a product advantage also to the most demanding customers thanks to the flexibility given by the possibility to integrate its solutions in existing customer lines.

Conscious of this topic importance, MG2 also dedicated a speech with a focus on Track & Trace systems and Integration during the Processing & Packaging Summit held at the Interphex New York trade fair.
The Summit, dedicated to sharing know-how and innovative technologies, took place at MG America’s booth on April the 2nd and the 3rd, and it involved different speakers who dealt with various topics on current industry significance, such as continuous manufacturing and pharmaceutical handling.

The Processing & Packaging Summit held by MG2 and MG America at Interphex New York


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MG2NewsSerialization systems and European legislation: MG2 Track & Trace