Adding Up the Numbers
Managing the data from serialization initiatives demands dedicated software.
As a packaging professional, you may leave most software selection up to your IT department or even upper management. After all—how many software applications are specifically targeted toward your operations?
Packaging-related software options are emerging. Many are geared toward supporting efforts to comply with the development of electronic pedigrees. As individual products and packages are given unique serial numbers that will form the basis for such electronic pedigrees, these numbers will need to be generated, commissioned, recorded, and communicated to other departments and supply-chain partners. Such data have tremendous value for more than just drug pedigrees—the data speak volumes about packaging line efficiency and can be used up and down the supply chain to ease business processes among a range of partners. Software is needed for creating and managing these data.
Puneet Mehta of HP Services—Consulting and Integration, part of HP Technology Solutions Group, says that “managing the numbers is one of the key considerations” of any product serialization project. “How do you guarantee the uniqueness of the numbers across all your product lines and all your sites?” he asked attendees during his presentation at the California Express Workshop in Irvine, CA, in late October, which focused on the state’s upcoming electronic pedigree rule intended to fight counterfeiting. (The workshop was hosted by the California Express Solution team, made up of HP, Nosco, Systech, and SupplyScape.)
When it comes to brand protection, HP offers a unique perspective. As one of the world’s largest IT providers, HP offers a platform that combines what it calls a “best-of-breed solution” from SupplyScape, Systech, and Nosco. The solution supports integration with SAP AG’s enterprise resource planning (ERP) solution. The firm also provides printing technology to combat counterfeiting. However, also a manufacturer of packaged goods, HP found its own brands under attack. From 2003 to 2005, through efforts to police the global supply chain, HP interdicted what it calculates as $100 million in counterfeit HP ink-jet goods.
In addition, HP also has an extensive radio-frequency identification (RFID) program. There are 33 manufacturing and distribution sites are currently equipped to use RFID.
Such efforts have generated more than 3.4 Gbyte of electronic product code (EPC) data to date that need to be analyzed, said Mehta. He says that in addition to logging the individual tag’s codes, companies also have to associate those codes with those of redundant two-dimensional bar codes printed on the items, as well as with the codes either printed as bar codes or encoded to tags on shipping cases. “The organizational impact is huge. The sheer magnitude of its complexity is daunting,” says Mehta.
GO FORTH AND MULTIPLY
For the numbers to be in sync, companies must ensure that they are keeping track of the relationships forming between codes, products, packages, cases, and beyond.
David DeJean, director of serialized products for Systech International (Cranbury, NJ), explained at the workshop that to comply with California’s 2009 mandate for electronic pedigrees, companies must encode either a 2-D Datamatrix bar code or an RFID tag with the product’s National Drug Code and a unique serial number on each salable package. His copresenter, Gregg Metcalf, industry market manager for Nosco Inc., added that in redundant coding programs, the 24 characters encoded in the Datamatrix code translate to 96 bits of data on the tag, conforming to the schema established by EPCglobal as the serial global trade item number (SGTIN-96).
|See Sidebar: From Items to Cases and Pallets -- And So On|
Software can be used to generate the serialized portions of these bar codes or EPCs, record their commissioning, and keep track of the “parent-to-child relationships” that are built. The SGTINs must also be associated with the serialized shipping container codes (SSCCs) of the shipping cases.
Systech’s packaging line management and integration solutions can be used for managing local serialization as well as data collection and aggregation, explained DeJean. The firm’s Serialized Product Tracking (SPT) Suite facilitates track-and-trace serialization at multiple levels, such as unit, case, and pallet. A software application in Systech’s production-monitoring solution Advisor, and therefore part of the firm’s new packaging execution system, SPT performs the following:
- Manages the application and verification of serial numbers in bar codes or on RFID tags.
- Verifies the uniqueness of serial numbers and commissions them for items, cases, and pallets.
- Handles packaging events such as rejects, reworks, and quality assurance.
- Presents data to other platforms, either in-house or along the supply chain.
Purdue Pharma LP has implemented SPT for expanding its Gen2 RFID tagging of OxyContin tablets. A fully operational deployment, SPT provides Purdue with a scalable, sustainable, and repeatable infrastructure offering item-level serialization, case aggregation, and an interface to the SAP’s Auto Information Intelligence (AII) application.
“The Systech [SPT] application provides us with insight into our products and packaging lines from the item level through the case and to our customer orders,” says Jeffrey Zerillo, senior executive director, supply chain, at Purdue. “Implementing Systech’s SPT gives us a scalable platform for serialized product tracking that can help us meet regulatory requirements, protect supply-chain integrity, and maintain vital operational efficiencies.”
Secure Symbology (Wayne, NJ) has created a platform consisting of proprietary software and other technologies for serializing packages using either RFID or bar coding systems. The solution is capable of interfacing with any manufacturer’s packaging process and systems, reports Secure Symbology’s CEO, Graham Sampson. The platform includes the Electronic Sequential Code (ESC) system, which generates and applies serialized 2-D bar codes and communicates those codes to Secure Symbology’s secure database solution, the Serialization Data Vault.
According to Kamal Mustafa, COO of Secure Symbology, the database serves as the central repository for these serialized codes. Serial numbers “flow into the serialization database from the packaging line Print and Verify modules. The database is then connected to the rest of the supply chain via the EPCglobal network and custom add-on modules,” Mustafa explains.
Secure Symbology’s Serialization Data Vault and supporting software can integrate with existing or additional ERP solutions, such as SAP and Oracle, says Mustafa.
Sampson adds: “We have developed a single-source solution that pharmaceutical manufacturers and packaging lines can rely on to track and document drugs through the supply chain.” Secure Symbology has worked closely with Catalent Pharma Solutions to develop and test the system on the contract firm’s packaging lines. “We have employed our system on various types of packaging for Catalent,” says Sampson.
SAP offers a family of solutions, including AII, Object Event Repository (OER), and Product Authentication (PTA). AII middleware captures all reads, including hierarchy and lot information about each product. It stores that data and then triggers business processes in ERP software such as item-level labeling, casing, and palletizing. SAP has certified Systech to provide AII.
OER brings that AII data “up to a higher level,” Michael Lipton, director of RFID and serialization strategy for SAP, says. “The repository gives visibility on what has happened down the supply chain.” Partners providing complementary solutions for XML document creation include SupplyScape and Cognizant. SAP’s PTA enables manufacturers to track their serialized products and then offer product authentication services.
TAGSYS and IBM have announced a Serialization Pilot Kit for pharmaceutical manufacturers’ mass serialization efforts. The Serialization Pilot Kit offers customers a complete system, from 50,000 tags to reader systems to software to TAGSYS’s and IBM’s services. Part of the Path to V2 program, the Serialization Pilot Kit was designed to support EPCglobal’s anticipated high-performance RFID standard—HF Version 2 (V2). TAGSYS and NXP have developed tag emulators and reader firmware and the newly released Medio L400 reader (in V2 mode).
For companies not interested in generating and encoding serial numbers themselves or even on the packaging line, Nosco can create serial numbers through the HP Security Publishing System. The firm can use those numbers to print serialized codes and then write the verified codes to RFID tags during label production. Labels with “preserialized” bar codes and/or RFID tags with guaranteed bar code grades or tag read rates are then supplied to pharmaceutical companies. “It is often easier to get started through preserialization,” says Craig Curran, director of strategic initiatives for Nosco. “Preserialization could speed up efforts to meet California’s rules while reducing capital costs.”
To build pedigrees, communicating serialization data to supply-chain partners will need to become a routine function. Bob Celeste, director, healthcare, EPCglobal North America, defines the function of a pedigree as “communicating the custody history for a particular medication.” EPCglobal’s Pedigree Messaging Standard defines the format for communicating document-based pedigrees using XML files that act as an “envelope for sending collections of pedigree” histories to trading partners. Celeste has likened such pedigree assembly to that of a Russian nested doll: pedigree information builds as the history builds, and data on all previous custodians move forward to the receiving custodian.
Three software vendors are currently certified to provide solutions for meeting the Pedigree Messaging Standard: rfXcel, for its Active ePedigree Management product; Axway, for its Synchrony ePedigree solution; and SupplyScape, for its E-Pedigree data management solution.
Graham Clark, vice president of business development for SupplyScape, explains that for years the electronic data interchange (EDI) 852 standard has existed, but there was inconsistent use of transaction data files. “A lot of time was spent cleansing the data,” he explained at the workshop. “We needed open and published standards and interoperable solutions,” such as the Pedigree Messaging Standard. “The data are secure and can be trusted, given the digital signatures. There is an immutability of data.” The existing EDI platforms can be used to exchange pedigree information, he added.
EPCglobal has also laid the foundation for a track-and-trace approach to providing drug pedigree information—the Electronic Product Code Information System (EPCIS). EPCIS standardizes event-related data sharing. It “supports a detailed representation of the location and state of material as it moves between organizational boundaries and provides for sharing between entities or partners” explained EPCglobal. EPCIS “will define a standard interface to enable EPC-related data to be captured and queried using a defined set of service operations and associated EPC-related data standards, all combined with appropriate security mechanisms that satisfy the needs of user companies.”
For a complete track-and-trace model, EPCglobal is working on other standards, such as ones on item-level tagging, serialization, supply-chain integrity, track-and-trace, and tag data. “A track-and-trace pedigree model would enable the whole supply chain to track product movement,” says Celeste. “There is a multitiered supply chain for pharma. Supply-chain partners [need to] be aware of each other even though they have no interaction, such as manufacturers and retailers, for purposes such as authentication.”
SUM OF ALL FACTORS
Clark said that companies can take the data from packaging serialization programs and use them to drive lean manufacturing practices. In addition, there is the potential to use product movement and financial transaction data in the electronic pedigree to leverage trade financials, including those pertaining to charge backs, returns, and Medicare rebates reimbursement programs. For these
purposes, SupplyScape has devised its On Demand Value Network (ODVN).
Sampson sees much value in serialization data. “Not only will the industry be able to meet legislative mandates, but they will gain powerful data on end-users, which is a by-product of our tracking system.”
Companies should be able to work on implementing item serialization and collecting serial data for pedigree assembly concurrently, said DeJean at the workshop.
But companies should not try to do everything all at once with the data, such as serializing every package and implementing new interfaces to ERP systems. “Even lightweight integration into ERP systems adds to timelines,” says Clark.
Instead, “deploy a solution that can support ERP systems, but start with an approach that will allow you to meet California’s electronic pedigree rules,” advises DeJean.