About Pharmaceutical Serialization & Track And Trace
In order to meet U.S. Food and Drug Administration standards for prescription drugs all drugs must have a drug pedigree. Currently most pedigrees are e-pedigrees, an electronic document that fulfills the Food and Drug Administration pedigree requirement. The purpose of requiring a drug pedigree is to protect consumers from counterfeit drugs or contaminated drugs.
Serialization, tracking and tracing is the primary way companies account for every product through every step of the supply chain down to the unit. Omega is only one example of a packaging system that allows tracking of individual packaging units using a unique ID on the bottom of every container.
The container un-scrambler allows full control over the containers as they pass through the printing, verification and rejection stations. This means every container has a readable container ID marking that can be used to track the product throughout production.
Downstream, containers receive larger, permanent fully serialized labels. Once the labels are applied to the container a camera using a serialized software management system syncs the label code with the container ID.
When containers are aggregated for final packaging, a shrink-bundler groups and wraps containers into a bundle. Container ID’s are visible through the bottom of the shrink-wrap.
Each bundle is passed over a camera system, which reads the container ID’s and identifies the containers in each bundle. A new label is placed on each bundle to establish the parent-child relationship making it easy to track and or trace an individual container or a bundle of containers.