Electronics drive labelling forward

Integral chips are extending the role of the humble label, while increasingly sophisticated labelling software is attracting the attention of the regulatory authorities. Andrew Smith reports on recent developments

Labels and labelling has become a hotter topic in the EU ethical drug industry since the introduction of patient packs in 1999, especially with generic manufacturers who traditionally supplied in bulk. OTC remedies, too, have created interest in this sector as the desire to increase shelf appeal becomes stronger with every competitive launch.

These factors, combined with the development of new labelling technologies, have provided a boost to the market for pharmaceutical labels, which is now worth over £200bn worldwide, and some £70bn in Europe alone.

The trend towards self-adhesive continues, with 90% of ethical pharmaceuticals and the majority of otc products now labelled in this way. Tamper evidence and the use of authentication devices such as holograms are also on an upward curve, as is the use of leaflet labels, the latter receiving a huge boost from the patient pack initiative which requires pharmaceutical companies to include all relevant information with, or on, the pack.

Less common, but set to grow rapidly, is the use of 'smart' labels which can carry sophisticated information for source tagging and tracing, as well as information to on the integrity of the product.

Weber Marking Systems national sales manager, Arthur Lugg, confirms this. He points out that barcode formats will become increasingly sophisticated with further developments along the lines of the matrix and stacked codes which require a smaller footprint to contain a greater number of characters — anything up to 2,000. But developments will not stop there.

He cites Radio Frequency Identification Data (RFID) as one of the most interesting alternatives. As the name implies, RFID uses remote radio control to store and transmit data to a central point. The label itself carries a silicon chip into which the relevant information is entered and stored.

'The beauty of this system', says Lugg, 'is that it means every label produced can be unique to the particular primary pack, outer case or pallet. This makes stock control, product tracking and tracing even easier to monitor and implement. Another important advantage is that once it is finished with, the label can be cleared and over-written.'

Like most new developments, he says, initial costs for RFID are high, but these are likely to reduce as the potential savings offered through greater control and efficiencies attract enough interest to establish the technology.

Smart labels can also be used to check product integrity by, for example, recording temperature measurements electronically. The label holds a record of temperature variation in its memory for up to 14 days, and can be interrogated at any time to check if the container has been put through conditions which might have caused product deterioration.

One recent materials development directly relevant to the chemicals industry is Fasson Direct-Therm200-OL from Avery Dennison. This is a direct thermal product that the company says uses a patent pending technology to create an on-demand, variably-imaged pressure sensitive label that is impervious to harsh solvents, acidic or alkaline contaminants.

The product incorporates a thin polyester film, over-laminated onto a direct thermal substrate. The polyester, coupled with a special release coating, enables the label to be imaged in typical thermal printers and 'used in applications that no other variable imaging technology will survive,' says the company.

The high throughput of labels in the healthcare industries, combined with the introduction of new label technologies and therefore techniques, means that the labelling machinery sector is also fairly active. However, this is an intensely competitive sector with low margins on 'standard equipment' and anyone considering a machinery purchase would do well to look beyond the machine and also consider longer-term customer support. This is especially so given the growth of computer-driven, networked packages that can now control and monitor packaging lines.

Safety concerns have also arisen regarding changes to software that are made after the original installation and operational qualification procedures have been completed. 'The dangers are obvious,' says John Clayton, managing director of Newman Labelling Systems. 'If changes to the machine's settings are not carried out by an authorised person and are not fully logged as part of a formal procedure, errors in labelling and other areas of the manufacturing process will compromise patient safety.'

electronic logging

Clayton highlights a new area of regulation directly related to this. 'The traditional paper-based system of record keeping is being supplemented by the electronic equivalent whereby changes are logged and recorded within the computer software itself,' he says. 'The FDA has recently revised the Code of Federal Regulations (21CFR11) to codify this practice. In particular the regulations describe the security arrangements — such as electronic signatures, passwords, and so on — that must be followed. The aim is to ensure that only authorised personnel can make changes to the machine and that such changes are properly authorised, recorded and tested.'

Clayton, whose company now offers manufacturers electronic logging and recording via electronic signature security as an option on its pharmaceutical labelling systems, also notes that the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use has produced a draft Good Manufacturing Practice guide which has a similar theme. This states that all changes to the computerised system should be made according to a change procedure which is formally authorised, documented and tested. to demonstrate that the final system is maintained in a validated state.

A number of new software packages are now available on the market, including two from Willett, which has also revamped its Label Printer Applicators range. The Connector software has four key modules and the necessary features for message design, selection and backup are provided with the Basic module, while the Network Module provides the ability to share information between up to 99 printers.

A user can view and print 'a whole host of reports' with the Production Reports module, says Willett, allowing efficiency comparisons for different machines, lines or shifts, while the Calibration and Diagnostics module concentrates on machine diagnostics, including detailed calibration comparisons.

The Blueprint software packages, said to be the 'next generation of message creation, design and print programs', supersede the LabelMate series. The BluePrint Pro version, provides more advanced features for manipulation of data and variable functions such as ODBC (Open Data Base Connectivity).

Extending the modular approach to Label Printer Applicators design, Willett's revised 262 and new 263 labellers are said to offer improved levels of control and integration whilst reducing the cost of ownership. Revisions to the range include options for dedicated PLC control, tamp unit position sensors and economic air application modules. Designed to accommodate any standard layout OEM print engine, the 262 and 263 can print up to 300mm/sec on label widths of 160mm and 220mmm and achieve a print resolution of 12 dots/mm.

Pago has also been developing its software capabilities and has now introduced a Pagosystem 100 print-and-apply system which can be networked to a customer's mainframe. The Pagowin software can be used as a standalone application, in a network, connected to a host computer or controlled by an external application. The Pagoedit label design, Pagoprint-it and Pagofont modules have all been incorporated. The Pagosystem has two installations of an ODBC module which allows connection to a third party database.

The Pagosystem 100 prints and applies a single full wrap label to containers. It incorporates a rotary pitching mechanism with separate drive motor and operator control, a fixed speed belt conveyor for smooth running product transport to enable accurate labelling and an adjustable top hold assembly with pressure pads to ensure all containers are securely controlled.

Meanwhile, Weber has introduced a new version of the 5100 series label printer applicator, which can place separate labels with differing information on the leading edge and side, side and trailing edge and, unlike many other models, says Weber, on the leading edge and top. Labels between 1in and 6in wide and up to 6in long can be handled at speeds between 5in to 12in/s at 204 or 300 dpi.

Flexibility has been the attitude adopted by Atwell Labellers which has introduced a self-adhesive labelling system capable of handling straight sided and tapered cylindrical containers. The Pharmatic is said to eliminate many of the problems associated with different shaped containers, and a typical changeover of bottle sizes is by turnwheel adjustment which can include numeric scales and counters. Head angling for tapered packs is a single adjustment which automatically includes any hot foil or thermal printer mounted on the label head.

The Pharmatic incorporates the latest AL120S programmable head, which allows up to 25 label and pack combinations to be stored alphanumerically. At changeover, the labeller is set by one button touch control. Options include inspection systems and a reject function. The standard version runs at up to 120 packs/min and a high speed rotary model up to 300 packs/min.

print versatility

The Apollo PA100 from Weyfringe Barcode and Labelling Systems also displays versatility, as it can be used both as a desktop label printer or an on-line print and apply system for over conveyor mounting. It prints text, barcodes and graphics in 200 or 300dpi and can operate with or without a PC.

When the print and apply function is required, the printer is simply slotted onto a plinth and stand module incorporating a pneumatic label apply ram. The conversion takes under five minutes and requires no special tools or training. The two-in-one system can be purchased separately allowing upgrades when required.

The Premier 100 Miniwrap from Premier Labellers is said to have been specially designed to provide a cost-effective solution to high speed wraparound label applications. A wide range of labels can be handled on round containers, with a comprehensive control module controlling speed, label set-up and coder control. Quick-release fittings facilitate fast reel changes for reduced downtime.

Picking up on the need for shelf appeal in otc medicines Katrina Hawker, marketing manager of Denny Bros, says, 'It can take less than a third of a second for customers to decide which product to use. In this short space of time, product image is all the customer has to go on.' She says a number of manufacturers which previously printed Denny's Fix-a-Form multi-page labels in two-colours have now moved on to using four or five colours to make their products stand out.

The patient pack initiative has also provided a boost to the company. 'The Directive has moved many companies to act when they otherwise wouldn't to produce the most detailed information possible and this has created an unprecedented demand for on-pack devices,' says Hawker.

Croda maps out label production

Having installed an Enterprise Resource Planning (ERP) system to help run virtually every aspect of its business, Croda Chemicals is now working closely with MAP80 Systems to get SAP R/3 ERP system to help improve its labelling operation too. Like all chemical producers, Croda has to comply with the strict labelling requirements of CHIP 99(2) concerning information on its labels, while also meeting specific customer requirements. This means there are limitless print variations due to the number of products made, the Health & Safety information required and the special requests of some customers. Croda was already using MAP80's Prisym software for label production and much of the information needed for the labels was located within a database, while variable information was keyed in at the time of printing. Once SAP was installed, Croda realised that every item of information needed for the labels, including the variable data, was already contained within various parts of the system. To make use of this, the company started to look for ways of drawing together all the information required for the labels and loading it directly into the Prisym program. Fortunately MAP80 has considerable experience in linking Prisym to many kinds of other programs including ERP and MRP systems. According to Tony Pickford, business process team manager at Croda, linking Prisym into the SAP system is making label production extremely simple and has eliminated the possibility of errors creeping in when information is keyed in manually.