Lasers help fight drug counterfeiting
Laser engraving: a cheap and effective “mass serialization” technique

The latest report on drug counterfeiting from the U.S. Food and Drug Administration (FDA), published in February 2004, made it clear that counterfeiting is a serious problem – not just for the pharmaceutical industry but also for the health of the world’s population. We need to fight drug counterfeiting with determination.

For decades, drugs have been identified by batch numbers to ensure quality control. These batch, or lot, numbers are printed on labels, blister packaging, boxes and lids, or stamped on tubes. They should be visible to the naked eye, and it is increasingly common to see them supplemented by barcodes to facilitate automated reading. In the USA, the FDA has requested since February 2004 that thousands of drugs be identified by barcodes. The main goal of this is to reduce errors in the administering of drugs, which US statistics show have cost more than $90 billion over 20 years. However, this well-established system of batch numbers and barcodes for individual drug types is not enough to stop counterfeiting. The FDA believes that the time has come to move to additional identification systems based on the concept of “mass serialization”. This would ensure the traceability, not just of the batch, but of each individual pill, vial, syringe or bottle. For products packaged in glass, such as bottles, syringes, vials and cartridges, mass serialization can now be done by using a high-performance laser to engrave a unique code on every container. The laser system was developed by Swiss company Frewitt Printing, which specializes in solutions for traceability and counterfeit prevention, and launched at Interpack in April.

Laser advantages
The Frewitt Printing laser engraving system is quick and secure. It is also economical, with a unit price of less than s0.0005 per code. The engraving is carried out directly on the glass, with no extra items or materials: no ink, no additives, no labels, and no electronic component. The technology is therefore easily integrated into existing production processes.
It could be argued that RFID (radio frequency identification) is a suitable alternative to laser coding. Certainly an integrated intelligent chip in each bottle could provide individual traceability. However, it is obvious that the emerging RFID solutions are not ready to be applied to glass containers. First, there is the question of price: an RFID tag is currently 1,000 times more expensive than an engraved laser code. Second, existing RFID tags are designed to resist to sterilization or freeze-drying. Finally, it is not easy to place RFID tags in glass containers using current technology. Laser engraving has the decisive advantage that it is impossible to remove the code once it has been engraved on the glass, in contrast to other identification technologies such as ink jet printing or labels. The engraved code also withstands sterilization, freeze-drying, and solvents. The speeds demanded by the pharmaceutical industry are high: 300 items per minute is the minimum, and modern machinery can achieve twice this. Frewitt Printing’s laser solution is fast enough to handle these demands. The system is modular and automated, so it is easily integrated with existing production lines and quickly adapted to changing production needs.
Compact and accurate
Space on containers is always at a premium, so the Frewitt Printing system uses a compact DataMatrix code that can store a large amount of information in a small area—typically a 24-digit code in an area of 1 mm2). The DataMatrix code is a standard that is becoming increasingly common in packaging and logistics. The codes for the pharmaceutical industry incorporate a high level of redundancy, which allows the information to be completely recovered even if 20 per cent of the code is damaged.
Drug manufacturers also need internal traceability. The pharmaceutical industry has some of the world’s most stringent standards for internal inspections to avoid handling errors, but human error is always possible. The Frewitt Printing solution, which combines unique identification of each container with automatic 100 per cent re-reading of the containers throughout the production line, can significantly reduce the risk of errors during manufacture. Codes that are visible can always be copied, and counterfeiters are renowned for their inventiveness and quick reactions. This is why Frewitt Printing’s proposed solution is not based on
visible marking alone. The unique characteristics of the engraving laser allow an invisible signature to be incorporated within the visible DataMatrix code, which in turn allows the authenticity of the product to be checked. This new technology of today answers the demands of tomorrow: a fully-automated traceability control throughout the production line is a big step forward in fighting the counterfeiters. Today the FDA recommends individual traceability (mass serialization). Soon, individual traceability of primary glass containers will be required, and the engraved DataMatrix code on each bottle will be as familiar to the end-user as the expiry date and lot number are today