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Applying variable data to low-volume blister packs: blister printing enables late stage customization and delivers new capabilities in the fight against drug counterfeiting.

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Late stage customization (LSC) enables pharmaceutical manufacturers to combine the cost-effective strategies associated with medium to long production runs with the benefit and flexibility of short runs that deliver market specific and small batch productivity. Increasingly, pharmaceutical packaging is customized with market specific content, including local language text, brand names and logos, all of which can be varied to suit individual countries, regions and customer groups, or to meet the specific requirements demanded by local regulatory authorities.

The pharmaceutical industry continues to develop new and improved anti-counterfeiting solutions which, used in combination, can reduce the opportunity and capabilities of counterfeiters. Current print and apply labelling solutions are commonplace in pharmaceutical production facilities, and are used to apply data coded labels to cartons and other packaging. However, with the advanced print driver software embedded within the G-MAT blister printing solution, it is now possible to print unique identification codes directly onto the lidding foil of each blister pack, or even to each blister pocket if required. Identification codes can be allocated from a production database, which is applied to the blister (or pocket) and then logged and registered for future verification through the supply chain and by the vending pharmacist.

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Project Background

A leading pharmaceutical company required a solution for late stage customization of blister packed drugs to enable market-specific data to be printed on the blister lidding foil. Aware that G-MAT Ltd had developed a bespoke high performance digital inkjet printing solution for bottle cap printing in the plastics industry, they approached us to discuss the possibility of developing the solution to suit their requirements. Initially, to maintain production cost efficiencies, the drugs were to be produced and blister packed in volume. However, supplied to a global market, this process delivers a typical industry problem: how to apply late stage variable data on smaller market-specific batch runs?

Process Requirements

The blisters are manually presented to the printing machine in transport cartridges--dedicated rectangular cardboard tubes. The solution requires a method for operator loading of the cartridges, automatic unloading of the blisters from the cartridge, identification and verification of the preprinted batch number applied during production, printed application of variable data specific to the batch and market destination, inspection of text and image print quality and finally reloading of 'good' blisters into recycled transport cartridges.

Whereas the blister count per cartridge coming into the machine is potentially variable, the blister count per cartridge going out must be a precise preset number with full traceability of rejected product. Furthermore, the machine required suitable inherent flexibility to be capable of processing blisters that were presented with a linear tolerance of [+ or -] 6 mm--as bowing was very often evident further to production and packing into cartridges.

Technical Requirements

The following technical criteria were presented for the development of a solution:

* Maximum operating speed (240 ppm)

* Incremental adjustment of operating speed

* No damage to blister or transport cartridge

* Adjustable blister count out

* Infeed/outfeed process buffering

* Optimized operator ergonomics

* Print colour: black

* Print resolution: >300 dpi

* 4Print accuracy: [+ or -] 1 mm

* Minimum font size: 5 point text

* 100% vision inspection.

The Solution

G-MAT Ltd developed a new concept machine to deliver the full technical requirements presented by the customer. Transport cartridges are manually loaded by an operator into a twin-track carousel mechanism with a holding capacity for 18 cartridges (approximately 9 minutes of process time). To achieve the required operating speed, the machine design is of a twin-lane construction, processing two cartridges simultaneously. From the carousel, two cartridges are presented to a cartridge unload station. Using advanced servo drives, the blister stack within each cartridge is independently lifted to a datum picking location and secondary lifters are incorporated to create a buffer zone that enables buffer stock to be processed during cartridge change over; this occurs without detriment to the operating speed.

Individual blisters are picked by vacuum from the datum position and placed at matched speed onto a transport conveyor where the blister is received and held flat byvacuum supplied to a profiled pallet. A validated industrial vision inspection system is integrated to inspect and validate the preprinted batch number on the blister; upon validation, the blister is then printed with variable data specific to the batch and destination region. Late generation print head technology is utilized for printing, complemented by print engine software specifically developed for the application. Post printing, industrial vision technology is employed once again to inspect the print quality of OCV text and images; only printed product achieving preset quality criteria will be passed as 'good' product.

Passed blisters are picked by vacuum from the transport conveyor and loaded into transport cartridges, which are presented by an operator in a replication of the loading carousel. Whilst blister quantities per cartridge coming into the machine are variable, the machine maintains an active count of loaded blisters to ensure a preset but adjustable cartridge count delivered from the machine. All 'failed' or rejected blisters are delivered to a high visibility reject location with part present sensing confirming that they weren't picked for cartridge loading, followed by positive confirmation that they were rejected appropriately. The construction and operation of the machine allows for full adjustment of operating speed, including single lane operation that is potentially utilized during line clearance and very low volume demands. In keeping with typical pharmaceutical packaging machinery, all machine process areas are highly visible with clear polycarbonate guarding allowing operators to visually inspect the working areas at line clearance.

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Further Development

Further to the release of this concept machine, G-MAT Ltd is already actively developing variations of the design. These include but are not limited to the following: higher speed variants; single lane variants and modular retrofit variants for integration into existing blister lines. In addition, the processed application of unique RSS codes and other identification formats are under development to complement the growing anti-counterfeit demands within the pharmaceutical industry.

For More Information

Jon Harris

Sales Manager

Manager

G-MAT Ltd

Shilton Industrial Estate

Shilton, Coventry CV7 9JY, UK

jon.harris@g-mat.co.uk

Tel. +44 2476 621 444

www.g-mat.co.uk
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Title Annotation:Application Note
Publication:Pharma
Date:Nov 1, 2007
Words:1018
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