The serialization is the process to convert a product in a flow of byte representing its status and to record it in a database in order to be able to reproduce exactly the same status when required.
Therefore to serialize a pharmaceutical product means to assure its traceability towards the whole production and distribution chain.
The traceability process can be obtained through three different steps:
Data Matrix: consists in printing on the packaging a 1D or 2D code which includes the product identification data.
Serialization: consists in adding to the 1D or 2D code a serial number to identify the single selling unit.
Aggregation: consists in identifying the sending box as well as the pallet through an additional serial number correlated to the single selling unit serial number.
The whole process, representing a revolutionary change in pharmaceutical market, has already started in some countries (China, Korea, Saudi Arabia) and will be implemented in USA within 2017 and in Europe within February 2019 according to the directive 2011/62/UE. The direct implication is that the production departments need to be upgraded with new technologies capable to manage the application of the codes and the consequent identification of each single product and each selling unit. In term of production it implies to equip the packaging lines with printing and reading devices able to identify the codes, associated to a software for recording and handling the information in conjunction with the central database.
On one side high investments are required to realize the project, on the other side it is fundamental to find the right break even point between the line speed and the time required to properly manage the serialization process.
MIPHARM has been one of the leading Italian companies approaching with methodical determination the markets new requirements. As a matter of fact MIPHARM has started the implementation process realizing in 2014 the serialization and aggregation for the Chinese market, and in 2015 the 2D Data Matrix for the Saudi Arabia market.
In the challenging future MIPHARM will play a key role on the market realizing in 2017 the serialization for Saudi Arabia and the serialization with aggregation for the USA, and in 2018 the serialization and anti-effraction on all products for the European market.
MIPHARM with innovative and foresight mindset has accepted the challenge positioning itself as leader in the pharmaceutical market.