There is no one solution that will fit all legislative requirements or customer requests. The best approach is to be clear which markets are being supplied by which lines and therefore determine the minimum requirements for product compliance.
Companies then decide which approach they wish to adopt, above the basic requirements of legislative compliance at a corporate, geographic, or site level.
The data to be tracked and traced as the batch number, the expiry date, the productive plan, etc., are all summarized in a 2D Datamatrix code, which includes all information to be traced in a very limited space, if compared with traditional bar-codes. This code will be applied on the product by means of a printer and following read and verified by a camera vision system.
It is therefore essential that pharmaceutical industries sit down with key packaging equipment suppliers to agree the best approach for a phased, long-term, cost-effective, and sustainable program to suit their needs.
To cope with the Track & Trace process, labelling machines can be equipped with the following components:
ink-jet, thermal-transfer, laser and hot-foil overprinting units to print bar-codes alphanumeric codes or 2D codes (Datamatrix)
overprint control systems
camera systems to control OCV/OCR
1D/2D or DM verification, presence, slope control, pattern matching, etc.
The offer may be completed with the possibility to apply and control RFID labels and integration with ePedigree and serialization systems.
Even if many of these activities are not IMA LIFE’s core business, its awareness of the importance of having a comprehensive offer to meet mass serialization increasing needs, brought to a close cooperation with specialized companies who have knowledge in vision systems and management information systems.
Ad-hoc solutions can be tailored to new packaging lines in order to meet with customer’s stringent and country specific requirements of the pharmaceutical industry.
The SENSITIVE AP400 is a leading labeller on the market, since it can answer to the most different requirements in terms of track & trace, with a lot of machines already up and running worldwide.
The machine has been developed according to a modular constructive design and is available in different combinations with several applications to be customized according to the country legislation requirements and to the specific approach of the pharmaceutical industry.
IMA LIFE’s labelling equipment feature the application of labels on one, two or three faces of the carton (only on top or only on lateral sides or on all of them), thus providing a reliable method to securing against the threats of counterfeit, misbrand and adulterated drugs.
The possibility to host up to 3 labelling heads and the high output (up to 450 cpm) gives the machine a high degree of flexibility.
The positive transport of cartons by means of toothed belt assures the indexing of each carton and avoids the possibility of misplaced ones or jams.
As well, the correct inter-distance between cartons and labelling head is constantly guaranteed.
Being the legal regulations for product track and trace relatively recent, pharmaceutical companies may have the necessity to upgrade existing packaging lines to be compliant.
In some cases space can be an issue, that is why IMA LIFE can provide a labelling machine with a very compact footprint (600 mm width), specially suitable in case of vignette, Italian bollino or holographic labels on carton’s top face.
Thanks to its long-term commitment to the sector, several pharmaceutical companies have chosen IMA LIFE as key supplier for labelling equipment.
Numerous IMA LIFE SENSITIVE machines have been installed in different plants of different countries thus realizing an economy of scale in terms of: validation activity repeatability, personnel training, spare parts rationalization, and so on.