IntroductionPharmaceutical manufacturers have many good reasons to implement track and trace technology within manufacturing and packaging processes. Serialization allows manufacturers to ensure the integrity of their product and compliance with emerging pedigree laws. Designed primarily as a response to the increase of counterfeit pharmaceuticals, pedigree and e-pedigree laws (for electronic documentation) require manufacturers to show the complete life cycle of the drugs they distribute, from the manufacturing process through the end-of-line packaging.
|2D and Serialization Codes Used in Track & Trace Packaging Lines|
Packaging Machinery for Track & Trace Lines
Serialization systems track the product from the time it is placed in its primary package (bottle, vial, tube, jar, pouch, etc.) to its final placement on a pallet at the end of the packaging line. This requires integrating inspection and tracking equipment from a track and trace system supplier with the packaging machinery at each step in the packaging process. It’s important to select an equipment provider who understands the requirements being faced by pharmaceutical manufacturers. Ideally, the packaging machinery supplier is also an integrator who can work with other OEMs to successfully implement a track and trace packaging line.
The track and trace systems incorporate several types of equipment.
First labeling or other types of coding equipment place a unique ID code on the
item being packaged, e.g. bottles, cartons, blister packs, bundles, etc. Next
cameras and other sensors that are capable of reading the ID are integrated
with the packaging machinery at various stages in the packaging process such as
cartoning or case packing. Print and apply labelers are integrated to label the
case with information about its contents, and these labels are also inspected
for accuracy. Reject systems are integrated to allow improper product to be
removed from the production stream.
|Cameras for Scanning Product Codes (Top) and the Stored Code Information (Bottom)|
The packaging equipment to be integrated with the serialization system should also be considered carefully. Automated packaging machinery is better able to handle production speeds needed to factor in the time it takes to record the serialization information without diminishing overall production rates. The process typically begins with the primary packaging equipment. Individual products, be it bottles, cartons, trays, or bundles, are labeled with a unique identifying code during the primary packaging of the product. It is this code that the track and trace system uses to create information about the contents of each carton, case and pallet.
Storing Serialization DataTrack and trace serialization systems incorporate a means for recording and storing the serialization data for each production run. This is usually accomplished through a dedicated PC integrated with the printers, cameras, and sensors. The centralized data point allows the system to distribute serial number information to each packaging level at each tracking point such as when the product is cartoned, when the carton is case packed and when the case is palletized. These systems interface with the packaging machinery controls to allow the exchange of information.
|PC Interface for Recording Serialization Information|