Creating e-Pedigrees

Published: January 01, 2009, By By Bob Neagle, Videojet Technologies Inc.

Variable data marking and coding isn't a foreign concept to most package converters. For years, many have been placing variable data on packaging materials for on-pack promotions their customers offer, typically using small character inkjet printers for rigid packaging or thermal transfer overprinters for flexible packaging.

Today, an increasing number of pharmaceutical customers are asking about mass serialization capabilities to help them create an individual product's electronic supply chain history, or e-pedigree, which also is being investigated by other markets, including perishable foods and personal care products. The reason is simple: compliance with regulations designed to safeguard the drug supply chain.

Perhaps the best known e-pedigree law is that of California, which recently extended its compliance deadline from 2011 to 2015. The largest pharmaceutical manufacturers lobbied for this change on the grounds that they need the extra time to deploy mass serialization solutions across the typical multiple production lines that will be affected. The change has prompted those manufacturers to investigate immediately the most efficient and cost-effective ways to approach this challenge.

Increasingly, those manufacturers are turning to their converter partners for assistance in mass serialization, because it can be an easier route to compliance than reconfiguring their own facilities. A pharmaceutical packaging line must permit variations — everything from how a product flows to how it is packaged to the amount of production lanes it utilizes. This makes it more challenging to accommodate the components necessary to achieve mass serialization because of the constant variations.

Conversely, a converter typically is processing labels and/or cartons, using respective in-line or off-line processes. Because it is the type of environment that rarely changes, it is much easier to integrate a mass serialization solution.

Even though the California e-pedigree deadline is six years away, converters should expect imminent questions about this topic, if they haven't already. However, converters need not be alarmed when those questions arise.

Comprehensive solutions geared specifically for converters' processes are available now. These solutions permit a converter to operate at optimum line speeds while simultaneously avoiding code duplication.

California e-Pedigree Law

According to the California law, an e-pedigree is “an electronic record containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from its sale by a manufacturer through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug.” A pharmaceutical manufacturer is required by the California law to have one-half of its product lines serialized by Jan. 1, 2015, with all lines serialized by Jan. 1, 2016.

While several other states have their own e-pedigree legislation, California's is the most stringent. It includes preemption language so its requirements will mirror those of the federal government when a national e-pedigree law eventually is developed.

The California law states that a “specified unique identification number” is required for e-pedigree purposes. Such a unique product identifier, typically a two-dimensional (2D) DataMatrix bar code, can be essentially a digital “fingerprint,” assigned uniquely to a given product package. This code becomes the means to track that individual unit throughout the supply chain by “marrying” that unique code to its shipping box and pallet. The code is also one of several types of variable data that a converter should be prepared to print on a carton or label when asked by a pharmaceutical customer. Other types of data include the following:

• A Global Trade Identifier Number (or GTIN), which includes information about the product and manufacturer;
• Lot or batch codes and expiration date, which typically are human-readable.

Integrated Mass Serialization

Components in a mass serialization solution must be tailored so the entire process of generating, printing, and verifying codes, as well as accumulating supply chain transaction data, is seamless for the converter. Those components include the following items:

• Software should generate codes like 2D DataMatrix unique product identifiers and maintain a master database that compiles future transaction information. Codes also can be generated by the pharmaceutical customer and loaded onto the converter's variable data printer.
• A line controller should interface with the line's variable data printer and camera system to manage the codes that are printed.
• A variable data printer, such as a small character inkjet printer, is key. Codes must be printed clearly at converter line speeds that can approach 1,000 fpm, so they can be read by the downstream camera system.
• A camera system should read the printed codes and grade their clarity. Safeguards typically are built into the camera system to sync with the line controller to sound an alarm or stop the line if substandard codes are being printed.
• A rewinder is necessary (for in-line processes), and/or a pulse feeder input device can be used for a folder/gluer (off-line). Ideally, the supplier should have partnerships with manufacturers of those products to ensure a seamless implementation. Variable data usually is printed just before the packaging material enters the rewinder or pulse feeder input.
• A secure FTP website must allow the converter to deliver the distributed codes to the pharmaceutical customer.

It may be tempting for a converter to develop a mass serialization solution by purchasing the individual components and integrating an in-house solution in an attempt to lower costs. However, that approach likely will increase both costs and downtime.

Unless a converter has a systems integrator on staff, it will not have the required experience that most suppliers of a mass serialization solution possess. Suppliers know what equipment is necessary, where it should be integrated within a converter's line, and most important, how to debug the system so codes are both readable and not duplicated — all in an approach that minimizes downtime. Anything less may result in substandard or duplicated codes and an angry customer that is not compliant with California's e-pedigree law.

The most important thing a converter can do regarding mass serialization is be prepared and investigate potential solutions before fielding a question from an important pharmaceutical customer. Chances are that question will come sooner rather than later, and it can provide the opportunity for a converter to be perceived as informed about crucial issues like California's e-pedigree law and concepts like mass serialization.

Supplier Infot

Videojet Technologies Inc. | www.videojet.com
PFFC-ASAP 308

Bob Neagle is business unit manager of the Brand Protection Solutions group at Videojet Technologies Inc. Videojet's Brand Protection Solutions group incorporates variable data marking and coding solutions with data management to provide robust and customizable track and trace solutions tailored to the specific needs of customers. He has a bachelor's degree in management from the University of Illinois-Chicago. Contact him at This email address is being protected from spambots. You need JavaScript enabled to view it..

Making Preparations

Converters should expect more questions about mass serialization and e-pedigree from pharmaceutical customers in the coming months and years, so the best rule of thumb is to contact a mass serialization supplier to learn about the solutions it offers.

Converters should invite representatives for a site visit and ask questions that will ascertain the supplier's understanding of converting. A converter that already has faced a question or even a mandate from a key customer should be prepared with data such as the following:

• The customer's exact requirements and timeline for implementation;
• The type of variable data to be applied;
• The tolerance for implementation downtime;
• The source of the variable data, including unique product identifiers. For example, will codes come from the customer or from the solution's code-generating software?

Being prepared can reinforce a converter's partnership with that pharmaceutical customer.

The views and opinions expressed in Technical Reports are those of the author(s), not those of the editors of PFFC. Please address comments to the author(s).