The company's new product, on display last week at the Interphex pharmaceutical trade show in New York, imprints security codes onto tablets and capsules using a high speed laser and according to the company offers a security solution that makes counterfeiting protected products "virtually impossible". The process uses a variable data laser (VDL) to imprint a 5X5 matrix code on the capsule surface, which can be read by a handheld scanner. "The code has the capability of holding up to 33 million combinations," explained Russell Lopez, Vardex vice president of operations, when US-PharmaTechnologist caught up with him at Interphex. "Every combination can mean whatever the manufacturer wants it to mean - batch number, NDC [National Drug Code] number, lot number, where it was manufactured, the expiration date…What we're driving is securing the product from the pill level." The VDL itself is a compact computer-controlled device that etches the matrix patterns into the product's surface using a very short pulse of laser light similar to strobe lights used in photography. It generates a pattern of alpha-numeric and simple barcodes, which can be combined with any desired images (such as logos or date/production codes) to create a complex compound codex on the pill itself. Along with the machine readable code, the company says that incorporating an image into the solution provides a simple extra verification tool for consumers, a feature that no other manufacturer of anti-counterfeiting technology offers. Using different laser types allows different materials to be marked, so as well as gelatine-based capsules or tablets other materials such as bottles, vials, glass, plastics and inked paper can also be marked, enabling a standard security coding protocol across all levels of packaging.
"We not only mark the pill," said Lopez, "we mark the container, the box, the crate to provide a uniform code throughout." According to the company, this novel system is also much faster than current branding methods which mark at a rate of around one unit per second with the aid of pricey mechanical systems. The VDL marks a product in less than a millionth of a second. "We can actually change and serialise the products at levels of 50 to 100 pieces or more per second," explains Vardex president Gene Robbins. The coding speed varies according to the type of material being marked and the information applied to each item, but for a simple codex the company says that a single unit VDL system can produce over 500,000 marks per hour - that's 12 million in a 24-hour period. "It provides the highest level of security at the lowest cost of investment," says Robbins. Another crucial feature of the technology is that although it is marking the actual drug product itself, the process does not add any chemicals or change the chemical composition of the product in any way. Being a non-contact process, any risk of contamination is minimal and the procedure is clean and safe. In addition to this, any variations in product speed or motion during the marking process have absolutely no effect on the quality of the mark; it's the same every time, which adds an extra layer of reassurance that the mark will always be readable further down the supply chain. The laser process can also mark different areas on the product, for example a 2D matrix code can be etched on one end of a capsule, a logo or image on the opposite end, and space still left on the capsule body for other regulatory product information.
The counterfeit drugs market has been blooming lately, proving a real thorn in the side of the pharma industry as it struggles to stem the flow of fake products and protect its supply chain from illegal diversion and imitation products. Only yesterday the US Food and Drug Administration (FDA) issued yet another warning to consumers reiterating the risk of buying prescription medication online, with numerous cases of counterfeit products claiming to be genuine drugs having been reported to the agency. The latest reported cases related to products claiming to be Roche's weight loss medication Xenical (orlistat), but that were found to be comprised either purely of talc and starch, or contained a completely different active ingredient (sibutramine) found in a prescription drug manufactured by Abbott.
With the global counterfeit drug market forecast to hit a staggering $75bn by 2010 and hotly touted radio frequency identification (RFID) products yet to offer mature, reliable solutions to the industry, alternatives such as Vardex' laser treatment could prove attractive to manufacturers, especially those looking to protect their products all the way down to the individual pill level.