Serialization and traceability inches closer to reality

Fig. 2. Cognex’ In-Sight 2.0 device can read and decode multiple barcode formats, and is programmed to meet 21 CFR Part 11 record-keeping requirements. Credit: Cognex

The pharma industry is turning a corner with the decade-long effort to establish item-level serialization (ILS) and e-pedigree data transfer. More and more companies are paying attention to the January 2015 start date for California’s e-pedigree program. The GS1 organization has issued a new guidance for adopting its serialization and barcoding standards. On roughly the same timetable as the California mandate, the European Union has adopted its own bundle of tracking serialized packages, coming out of the “Falisified Medicines Directive” originally issued in 2008, and now being reviewed by EU member states.

In the US, currently, the main focus is on pharma manufacturers installing serialization equipment on their packaging lines—a logical place for the effort to start, since nothing else can happen in the supply chain until product packages are serialized. Nearly all of the major manufacturers have active implementations going on; the beneficiaries are vendors of barcoding equipment and the machine-vision systems that ensure that packages have been coded. Examples of the former are Domino Amjet, Videojet, Zebra Technologies and SATO; examples of the latter are Cognex, Label Vision Systems and Seidenader. Packaging machinery vendors such as Bosch Packaging, Mettler Toledo or Omega Design are also beneficiaries, producing machines that are “serialization ready” to a greater or lesser degree.

That’s on the hardware side; just as critical as well-functioning hardware is the need for packaging-line software that delivers correct barcodes and then collects the production-line data and serves it up to plant- or enterprise-level production systems. Two companies—Systech International and Optel Vision, appear to be breaking away from the pack for these data-handling systems. Both companies are adding staff at a hefty clip; Optel says that it has doubled its staff in the past year. Systech, which opened offices in Europe and Asia several years ago, now has a network of 11 “Select Service Providers” across the globe, and claims that the network represents upwards of 4,000 project managers capable of implementing a Systech serialization system, according to Barry McDonogh, VP business development.

For its part, Optel has just announced a relationship with ROC IT Solutions, which was formed by several engineers who had worked at an IT services company, Blue Vector, that was a player in the ILS arena in the mid-2000s, but went out of business after the California e-pedigree rules were postponed in 2008. Ken Fallu, marketing manager at Optel, says that ROC brings warehouse and distribution data-management capabilities to the Optel offering, TrackSafe.

McDonogh says that based on his estimates, there are 10,000 packaging lines in the global pharma industry, but only about 1,000 of them have had serialization equipment installed or contracted for. Getting the entire industry—vendors as well as clients—ramped up in the next 2—3 years is going to be a challenge. (Adding to this concern: the medical device industry, which has its own serialization program beginning to roll out, and has another 15,000 packaging lines—many of them will be using very similar labeling and machine-vision systems.)

“Our dance card is rapidly filling up,” agrees Mark Shaffer, a business development manager at Domino. “There’s a finite bandwidth for any vendor to be able to deal with implementations.” Furthermore, he says, second- or third-tier, smaller pharma manufacturers typically have fewer internal staff or resources to manage a serialization project, so their needs will be even greater. “By some point in 2014, you’re not going to be able to buy your way out of the project workload,” he says. (See related story)

Fig. 1. Timetable for global serialization initiatives. ‘Level of aggregation’ refers to how much of the supply chain is engaged (manufacturers, wholesalers, others). Credit: Systech

Even so, the vendor community is getting bigger. Many vendors have been able to hang in through the drought years following the 2008 California postponement, and more players may be entering as the business cranks up. Acsis, a leading provider of warehouse management data systems, has just won a project with Daiichi Sankyo. Acsis says that Daiichi will be installing a pilot system making use of Acsis’ Serialization Management Suite, with Cognex and Domino equipment being installed at the company’s Bethlehem, PA packaging plant, and with an integration to SAP’s Auto-ID Infrastrucure (AII) and Object Event Repository (OER)—the enterprise-level systems to share serialized data with other entities.

Other vendors with some type of packaging-serialization software include RfXcel, Covectra, Xyntek-Antares and Markem Imaje USA. The GS1 organization, which has developed the global serialization standards for barcoding and communicating serialized data, has a website that lists companies that have sought certification for its standards; the relevant ones for pharma serialization include EPC/RFID and EPCIS (EPC Information Service).

In a perfect world, GS1’s standards would be broadly filled out, and vendors would be lining up for a well-defined certification process. But there are various standards in various stages of evolution (EPCIS, EPC/RFID and others), and claims and counter-claims are flying about who is compatible with what. “Getting ‘certified’ is more a marketing move at this point,” says one vendor, noting that compliance with the standard (as demonstrated by communication capabilities) can be achieved whether or not the software package is certified—the proof is in the implementation.

Enterprise level

Mention of SAP’s enterprise products brings up the next important level of a serialization program: how to collect and store the packaging line data. Systech plays at this level with its Guardian product line (packaging line serialization is handled by its Advisor product). A range of other companies, including some of the major enterprise-level firms, offer these enterprise-level systems, including Oracle with its Pharmaceutical Serialization Manager, Axway with its Track & Trace product, Verify Brand (VB Enterprise, ver. 4), Fastpoint Technologies (Fastpoint Track and Trace), and TAKE Solutions (GeminiSeries). Mettler Toledo acquired a German automation vendor, ProcessControl, in 2001. IBM had developed its InfoSphere Traceability Server as well, but sold the business to a Los Altos, CA, IT company, Frequentz, last September.

Serialization issues at this level involve standardizing a way to gather both “data” (serial codes) and “events” (actions such as labeling, cartoning, transporting) about the items coming off the packaging line; in large part, this is the realm of the GS1 EPCIS standard. Bob Celeste, director of healthcare at the GS1 Healthcare US organization, notes that the group published, in February, a new guidance document for EPCIS, “Applying GS1 Standards to US Pharmaceutical Business Processes,” (available for download at www.gs1us.org/industries/healthcare/tools-and-resources/implementation-resources) that provides the current thinking on these issues; in particular, the “use cases” to handle exceptions or other out-of-the-ordinary situations that will be encountered when a serialization program is up and running (examples include: unreadable codes, mis-located items; missing items in an aggregated container). The document is also very explicit about recommended types of barcodes for items, cartons and larger containers like pallets, each of which is to be coded in a fully serialized supply chain.

The GS1 Connect meeting (San Antonio, TX, June 10—13), which brings together product-identification vendors and clients from all industries, will contain sessions from the Traceability Adoption Workgroup that is overseeing the evolution of EPCIS and related standards.

There is still work to be done on EPCIS, and at something of a macro level, EPCIS is driving how the California Board of Pharmacy (BoP) is looking at its requirements for e-pedigree, and vice versa. The California BoP is again holding quarterly or semi-annual meetings on details of compliance, and to continue to keep pressure on manufacturers and other supply chain participants to move forward. One of the technical details still being hashed out is how to handle “inference,” the practice of assuming what specific serial numbers are contained inside a carton (of many items) without opening the carton and manually checking them. Inference is a big concern for wholesalers, whose traditional practices will be affected if inference can’t be practiced.

Technology, though, might be making this inference issue go away, or at least become a lesser significance. According to a Cognex representative, it is now possible to mount machine-vision cameras at a case-packer station so that the contents of a carton (containing multiple items) can be read and verified. “There are operational and line issues to be worked out, but the technology is there,” he says.

A Washington action?

Unlike past years, sources contacted by Pharmaceutical Commerce are unanimous: there will be no delay or new postponement of the California standards. But even that statement needs to be qualified: California’s existing legislation very explicitly defers to the federal government, if there were to be a federal pharmaceutical traceability regulation established. An industry group, the Pharmaceutical Distribution Safety Alliance (PDSA), based in Washington, DC, pushed mightily last year to get such legislation through Congress, but the proposal (which would have delayed traceability implementation) did not make it into final legislation.

A PDSA spokesman gives this comment on the current status:

PDSA continues to advocate for enactment of a national supply chain legislative solution. We are encouraged that strengthening the security of the supply chain was included in a recent set of priorities issued by the leadership of the Energy & Commerce Committee … will help advance the issue and get the job done as quickly as possible this Congress.

The “recent set of priorities” PDSA alludes to was a letter written by three Republican leaders in that committee that states, in part:

As drugs are manufactured and shipped across the country, patients want to know that the product they will eventually use is safe. At the same time, a fragmented or overly burdensome regulatory system for monitoring the drug supply chain could drive up costs and put treatments out of reach. To protect patient safety and access, and to provide clarity to drug makers, distributors and pharmacies, we will create a single, streamlined framework for drug supply chain tracking.

Given the general animus of the Republican side of the aisle to additional regulatory requirements (especially from an agency, FDA, that is often on the outs with Republicans), it remains to be seen how “streamlined” new regulation could be.