More IT, packaging vendors pile into the serialization space in anticipation of 2015 CA regulations

Even though serialization and track-and-trace rules did not make the final cut of the FDA Safety and Innovation Act signed into law in July, a growing number of pharma manufacturers and contract packagers are installing necessary hardware and software now. Part of the rationale is the upcoming e-pedigree rules scheduled to go into force in California in 2015 (these would have been superseded had federal legislation passed); and another factor is the growing number of countries outside the US that have implementation deadlines in place.

The latest set of players to enter the arena are Xyntek, Inc., a Yardley, PA, systems integrator with experience in packaging, quality management and regulatory support, which is partnering with Anatares Srl (Brescia, Italy), a machine-vision company serving the life sciences markets in Europe, South America and Asia. Antares claims to have more than 250 packaging lines using its machine vision and serialization technology. It also has a year-old partnership with Cognex, Inc. (Natick, MA), an industry leader in machine vision systems.

Serialization is a necessary first step to industry-wide track-and-trace systems, but by no means the sufficient step. Standardization among industry trading partners, and the willingness (or regulatory requirement) to share pedigree information are still to be worked out.