Solutions digital printing serialization primary packaging

SEA Vision, Domino and Gallarus: together for the creation of digital printing solutions

SEA Vision has developed the first solution available on the market for the identification and serialization of primary packaging (blisters, trays, sachets, etc.) or related sub-units (single-dose blisters) in collaboration with leading digital printing firm Domino Printing and with the Irish company Gallarus Industries Solution. This solution is strategic when this kind of packaging is distributed or when it is used separately from its original pack both by the end user or other parties along the distribution chain (for example in hospitals or pharmacies in developing countries). This separation from the secondary packaging is in fact a manipulation of the original product, thus creating a potential real risk for patient’s health.

Although this is not yet a mandatory requirement in line with national regulations, at SEA Vision we have identified in this new possible challenge an opportunity to offer to our customers a solution that anticipates a future need.

In conclusion, it should be noted that the regulatory bodies have not yet addressed this regulatory gap, partly because of the difficulties that existing technologies have encountered to date: a limitation that, thanks to the ongoing research and development carried out by the three partners SEA Vision, Domino and Gallarus, can now be said to have been overcome.

PRE-REQUISITES

Drugs are today commonly packaged inside a box in thermoformed blisters (PVC or alu), bottles, sachets and tubes. If solid products in blister packs are more easily convertible into unit doses, the biggest difficulty lies in marking them with unique codes in order to trace their origin and their path along the distribution chain. Increasingly the request for serialization of primary packaging emerges from draft regulations or from manufacturer’s requirements, but until now had always been removed due to the technological gaps, which have now been overcome.

Furthermore, although this requirement is not yet regulated, the serialization process has already been adopted by some pharmaceutical companies for labeled products as such as bottles, vials or tubes.

It is essential that the identity of the product, lot and expiry information are maintained intact and legible, not only for the patient in the form of Human readable data, but also for automatic reading devices such as scanners or smartphones that can obtain all the useful information on the drug by reading a barcode or 2D code to facilitate the automatic processes of distribution and verification such as in hospital pharmacies..

To increase the safety and protection of patients, there are mainly two areas where an urgent regulatory update is envisaged:

In hospitals, where the drug, purchased in the form of a hospital box, arrives through several steps of product singularization- and is then dispensed to patients as a single dose. In case of human error (for example, accidental mix-up of products) and without a system to control the identity of the drugs, incorrect dispensing to patients could be a real risk.
In developing countries, where it is common practice to dispense the product in doses that are smaller than the secondary packaging. This problem makes it impossible to identify the origin of the products – and therefore their authenticity.

Moreover, it is also necessary to consider that people are used to carrying with them a portion of the blister (and not the entire drug package) for personal use when they are away from home, for example at work or on vacation. How can we be sure that the products have not expired without being able to see the entire package or the original package leaflet?

THE SOLUTION

SEA Vision, Domino Printing and Gallarus Industries Solution have launched on the market a brand-new range of printing and control technologies, in compliance with the requirements described above, all integrated in a 4.0 environment. The combined skills of these companies, have allowed them to manage all the aspects of such a challenging project, to create a cutting-edge solution for any pharmaceutical manufacturer who wants to be ready for future regulatory implementations – and at the same time to gain an added value to their packaging processes.

THE PRINTING AND INSPECTION PROCESS

Domino’s commitment has focused on digital printing technology optimization, designed to meet customer needs in different ways:

to print the artwork and variable data in-house, directly on a neutral reel, both to reduce the risk of mix up and to optimize material procurement processes;
to print at high speeds on aluminum foil, thanks to the specially developed UV curing technology, overcoming the usual problems of ink drying at high production speeds
to print on large format aluminum web in order to increase productivity
receive the serialized data set from the SEA Vision traceability system (yutrace)

SEA Vision has focused its activity on two research and development areas, which have involved the choice of hardware and software development.

Regarding hardware, the Contact Image Sensor with CoaXPress 1.1interface was identified by SEA Vision as the most appropriate tool for the needs of this technological challenge. Designed and integrated into the SEA Vision Software, this sensor allows you to:

Homogeneously inspect web up to 367mm with high resolution (600dpi)
Inspect foils of a wide range of materials
Achieve a high image transfer speed, allowing line speeds of up to 75 m/min
Minimize the physical footprint in the machine thanks to an integrated lighting system
Cancel the shear deformation effect on the image, to optimize print quality control, thanks also to the continuous foil dragging

As a natural consequence of the adoption of this device and the very challenging demands in terms of calculation speed, it was decided to take advantage of new generation 16 core processors, with high clock rates and the ability to manage huge amounts of data.

As regards the development of the software, SEA Vision has created new algorithms for reading codes and controlling print quality and has further developed its own application, in order to be able to make the most of the performance of the available threads.

The concepts of temporal and spatial parallelism have been developed, to allow dividing the weight of the calculation of an image (or multiple images of the same camera) present in different memory banks) on parallel threads, maintaining the acquisition chronology.

An important step was to develop the print quality verification algorithm in gray and color levels, using the digital model made available by the printer as a reference.

Finally, to meet the high speed requirements, the aim was to reach the highest levels of performance in terms of reading the ECC200 codes, without impacting the ANSI Grading control, in accordance with ISO-IEC 15415, ISO-IEC TR 29158 and ISO- IEC 16022.

Thanks to the use of the quick search algorithm, benefiting from the fact that, in this type of application, it is not necessary to correct large rotations of the code itself, it is possible to reduce the calculation time for each code.

SEA Vision’s contribution includes:

100% print quality verification (black and white or color) at high speed.
High resolution sensor (600 dpi)
Automatic calibration tool for optimized graphic control
Automatic acquisition of the digital graphics model
Serialization printer data management
Real-time Track and Trace management
Native integration with Suite 4.0

THE INTEGRATION ON AUTOMATIC SOLUTIONS – GALLARUS

Together with Domino and SEA Vision, the system integrator Gallarus Industries Solution has combined the commitment of the partners into a single automated solution, which can be provided both off-line and in-line in different models

K600G Roll-to-Roll (Offline)

K600G Near-Line

K600G Top-of-Line

K600 for OEM

The first model developed is the K600G Roll-to-Roll, designed to reach maximum printing speeds, in a scenario of reel preparation in a warehouse or offline.

This solution allows for the printing and checking of the blister coverage foils, at a speed of up to 75 m/min, for serialized and non-serialized batches, with the maximum flexibility. This version is also available for loading the reels to be placed side by side with the blister machines in the department (Near-Line or Top-of-line).

On the other hand, OEM solutions are designed for compact integration, directly on blister machines, in which the loaded reel is printed directly in the machine.

Finally, there is another version that provides complete flexibility of adaptation to the requests of the final customer, using digital printing directly on blisters or other single primary packs already sealed.

SERIALIZATION – SEA VISION

The offline solution has allowed SEA Vision to fully express its proactive spirit by studying an intelligent solution for rejecting the defects of printed rolls.

SEA Vision has designed a waste management system called “smart tracking”, which allows the Roll to Roll machine to avoid any stops due to cutting and joining portions of foil; this creates the advantage of eliminating production slowdowns and material waste.

This management is applicable whether the need is to prepare reels for batches of serialized blisters off-line, or whether you want to prepare non-serialized printed reels, but with verification of the quality of the printed artwork, before it reaches the blister machine in production.

It is clear that a multi-level track and trace architecture integrated with all existing company systems is recommended to automatically manage the flow of information. This is why SEA Vision has integrated the 4.0 Pharma Software Suite Yudoo, a more comprehensive 4.0 infrastructure that allows a total digitization of processes.