Patient safety at the forefront

The pharmaceutical industry is the one to watch; technologically speaking, it leads and others follow. How is it handling globalisation of markets and products? Where is technology moving to meet the needs of manufacturers and compliance with latest European safety standards? Who is developing processes that perform to order at gathering speeds of production, to meet high expectations of quality and integrity, shave excess costs and deliver an attractive bottom line for manufacturers?

The “world’s first” fully integrated EPC (electronic product code) solution for the pharmaceutical industry is ready to roll throughout Ireland after a pilot demonstrated end-to-end traceability of haemophilia products and efficiencies in cool chain logistics. The second phase of the trial – run by Domino Printing Sciences, of Cambridge, and GS1 Ireland - will move beyond the use of barcode labelling and introduce mobile phone technology, GPS and radio frequency identification tagging, for geographic tracking and environmental monitoring. This panoply of technologies is anticipated to bring even greater benefits to haemophilia patients of St James’s Hospital in Dublin.

The first phase established an EPC system that assigns a unique number to every item that rolls off a manufacturing line. This allows every party in the supply chain to track products at item level. With a mobile phone integrating special software, the patient will be able to scan the barcode on the drug container when self-administering the product dose at home, which will automatically update their records at the hospital.

Tony Walsh, European business manager of Domino’s Integrated Solutions Group, adds: “The software instantly links to the database - at a blood transfusion service or hospital – that has the inventory information, which records the removal of the product from the fridge, and as it runs down on stock, a visual warning signal is given via the phone.”

The system has genuine global potential thanks to the widespread access to mobile phones, even in the developing world, where communities and hospitals can be set up with specially adapted phones. Walsh’s watchword is: “Keep it simple”: “Technology that is too clever keeps it out of the hands of people who need it,” he says.

One of the important characteristics of blood products and pharmaceuticals is sensitivity to temperature and humidity. Under certain conditions medicines can lose their efficacy and even become poisonous. Active RFID can be used to link with and monitor the supply chain environment and, in the event of a problem, it will be possible to withdraw any vulnerable product.

The trial’s second phase is likely to proceed in Q4 this year or Q1, 2007, Walsh told Packaging Today: “All the previous trial partners are in place, joined by Qinetiq, the spun-off former Ministry of Defence technology unit, which will bring on board a ‘clever’ GPS system and UHF RFID tags for environmental monitoring.”

A “totally new” unique-coding technology, FractureCode, is targeting pharmaceuticals for efficiently managing supply chains and as a further deterrent to counterfeiting. The technology is designed for item-level use alongside Data Matrix, PDF 147 and RFID tags, says FractureCode, a division of Filtrona based in Copenhagen.

The “dumb” code, combined with standard high-speed camera systems and unique algorithms, creates a database. In appearance it is a group of lines set at tangents in a code window, generated to produce a random serial number or fingerprint. An optional prefix can carry fixed data in matrix form. Its printing is by conventional rotary gravure, flexo and letterpress, litho, intaglio, and combinations of these – on to materials including paper, PP, PET, PVC and Teslin.

The code size can be as small as 1mm square and allows “an immense number of unique combinations”- – a claim verified by the Danish Technological Institute according to FractureCode – by using between four and 12 intersecting lines. The “almost infinite” possibilities are claimed to dwarf the world population, the number of US banknotes in circulation and even servings of Coca-Cola sold per year!

FractureCode users can expect to be able to track and authenticate host product containers throughout manufacturing and distribution and, importantly, the system can handle large volume production runs.

Five years in development, it “defines its own market sector”, says Stephen Pinchen, FractureCode’s commercial director, of a technology that supports the European Federation of Pharmaceutical Industries Associations’ (EFPIA) move towards product serialisation as part of its proposed new standard.

It will take all parts of industry to work to the same goal; coding systems need clever code applicators. Producing some 300,000 products a day across its pharma range for a global market, Ivor Shaw called on Imaje for reliable and fast equipment to consistently print millions of characters at speed, every day.

Ivor Shaw manufactures single user medical devices and customer procedure packs supplied under the brand name Pennine Healthcare. To keep up with throughput of the packaging machines, the Imaje printers must operate at full capacity speed. The twin-head, twin-jet Imaje S8 Master prints product description, batch codes and lot numbers onto pre-printed paper and polythene, at some 1.85 million characters/hour Ivor Shaw also owns three twin-jet 9030 printers. Using a single twin-jet printhead operating in forward and reverse mode the model is printing around 1.7 million characters per hour.

“Operators can download messages quickly and simply - imperative when there are an average of 25-30 message changes per day,” says Darryl Orridge, plant and development manager, who adds: “We just switch the printer on, select a message and leave the machine to run.”

Sunala is targeting the animal health sector with its thermal inkjet printer products, to help the industry meet the new medicines identification standard, the introduction of which will have “positive global implications” believes the company.

The new and potentially influential standard agreed by IFAH (International Federation for Animal Health) selected the 2D Data Matrix code for its “flexibility and accuracy” to meet the European Directive for “effective traceability for the possession, wholesale distribution and dispensing of veterinary medicinal products”.

The Data Matrix code can contain a greater amount of information than EAN 128 versions and is more easily included onto primary packs or labels and outer cases. The potential for 2D Data Matrix on a worldwide scale is a vital consideration in a market where products are becoming increasingly global, says Sunala.

The high print resolution to make these codes readable is offered, claims Sunala, by the 600dpi resolution of the Wolke m600 thermal inkjet printer.

“TIJ technology is a reliable, cost-effective technology that will enable manufacturers both large and small to successfully meet this standard,” says Sunala’s managing director Sue Brocklehurst. She believes the initiative by IFAH could spur other industries to consider developing a global identification and traceability standard.

Cost saving is a further goal for equipment makers, and a high-speed Schubert automated packing system is said to be helping to cut packaging material consumption for a European pharmaceutical manufacturer.

The Schubert TLM-F2 line uses a cyclical method to package blister-packed tablets into dispensing wallets at the rate of 240 packs/minute. Format re-setting is simple and fast, and a variety of different wallet designs can be processed on the same machine.

“A growing number of pharmaceutical manufacturers are choosing to pack their tablets in carton strips,” says Alan Law, managing director of Schubert UK, of Coventry. “It is not only a very economical way of lowering packaging material consumption but also has benefits for the consumer. As the tablet blister pack is sealed within a wallet, it ensures that important consumer information such as dosage instructions remain attached to the product.”

To load, the blister packs are fed into the “compact” machine from a high-capacity product buffer, which will store up to eight minutes’ worth of production.

They then enter a rapid thermoforming and sealing section which glues the blister packs into carton strips. These strips are folded around the packs by specially designed, quick-change tools. Finally, the machine applies a sealing label and laser imprint to the wallets.

The German manufacturer is using the Schubert system to produce two different packs with a 20-minute reconfiguration time between sizes. Manufacturers also want the ability to guarantee total pack integrity. A film to assist quality control for validation and calibration of sealing die pressure during drug packaging has been developed by US company Sensor Products, whose customers include GlaxoSmithKline and Cardinal Health.

Pressurex comes as a thin, clear Mylar sheet, similar in appearance to a sheet of paper. When placed between contacting surfaces, the film instantly and permanently changes colour. The colour change correlates to the specific amount of pressure applied – similar in concept to interpreting litmus paper. Pressurex can be laser cut for small precision areas and is suitable for applications where water, oil or other liquids might be present.

Be it safe delivery of drugs and medical devices to patients, ability to trace products for possible recalls, or systems that enable speedier, more reliable and cheaper production of correctly coded, 100% secure packaging -– all are worthy aims. And all, on an individual patient basis, can exclude the risk element in taking prescribed and over-the-counter drugs. But looking at the larger, global picture, those self-same developments ultimately will be able to offer added protection for profits and a company’s good name.