Implementation deadlines for California's ePedigree program are now four years away for pharmaceutical manufacturers. The
state's mandatory plan for serialization and traceability of item-level packaging is an important step toward improving supply-chain
safety. Manufacturers must begin to roll out serialization starting in 2015, followed by wholesalers and repackagers in subsequent
(IMAGE COURTESY OF TRACKINSIDE. THE COMPANY'S LASER-MARKING SYSTEM PLACES A 2D BARCODE ON A BD HYPAK SYRINGE.
A cutting-edge solution for the serialization of glass containers for the pharmaceutical industry uses a laser-coding system
that places an identifying mark on individual vials, syringes, or ampoules that does not compromise the stability of the glass.
An attractive feature of the system is that it easily integrates into existing production lines. A collaboration between Roche
Diagnostics, SCHOTT forma vitrum, SCHOTT-Rohrglas, Seidenader Vision, and Vesdo developed such a solution, which places a
2D barcode containing identifying information, such as batch number or the date and location of manufacture, on a container.
Another coding system for glass containers uses a laser to place logos, alphanumeric text, and 2D barcodes below the surface
of the glass, which makes counterfeiting the information extremely difficult. Using a femtosecond laser and proprietary marking
technology, TRACKinside's unique identifiers "are made by changing the refractory index inside the glass, which creates a
permanent, indelible, and highly readable set of codes," says Adrian Simmons, marketing manager at TRACKinside.
The marks are easy to read, and covert marks that require the use of a scanner for authentication can also be used. The solution
is designed for containers made of clear and colored glass as well as clear plastics. The company's laser systems feature
marking speeds of up to 10 products per second. TRACKinside's process does not alter the surface of the container or produce
microcracks, which would weaken the glass. Because no inks or additives are used, there is no chance of contamination of the
product, which means additional FDA approval is not necessary, says Simmons.
TRACKinside's item-level serialization solution provides traceability and authentication capabilities plus added security
for pharmaceutical glass containers because the marks are hard to fake. "In addition to product and client information, each
2D barcode can have hidden coded elements therein, as an extra anticounterfeiting feature," Simmons says. He added that "the
possibility that counterfeiters can copy this technology is remote."