VisioTec System Supports E-Pedigree to Protect Pharma Supply Chain
Increased counterfeiting means stepping up the technology to fight it.
By David Vaczek
Uhlmann’s VisioSafe serialized coding solution uses the VisioMark laser marking system for applying 2D codes.
Combating counterfeits grows more difficult as product copies get more sophisticated and designs come closer to the original. Drug manufacturers increase careful monitoring and use more-complex designs, mainly on the packaging side, for a higher level of distinction. Improving technologies, however, are available for product pirates as well. A high percentage of drugs are already counterfeited and, even worse, are on the market.
The target to prevent counterfeits on the market must be pursued uncompromisingly because an incorrect tablet or an incorrect or missed dosage might have disastrous consequences for the patient’s health. Followed by loss of trust and image for the manufacturer, liability claims and judicial proceedings are the next possible consequences.
Regulatory authority (state and federal), manufacturer and distributor all share the common goal of supply chain integrity and patient safety.
The VisioTec division of Uhlmann Packaging Systems (Towaco, NJ) now offers a turnkey solution for the serialized coding of item packs, cases, and pallets with its VisioSafe solution. VisioSafe includes digital printing or marking of serialized codes, vision inspection, and a line-level database server for supporting e-pedigree applications. Packagers optionally can use RFID and attach tags, which are then activated and read, with database merging of tag and printed data. One of the challenges to comply with the California pedigree statute besides the critical factor time is how to approach existing packaging lines.
Serialized boxes carry Ulhmannï¿½s laser-created data matrix codes.
For adding serialized coding capability in an easy retrofit, VisioTec planned to display at WestPack in Anaheim the Total Quality & Coding Center (TQCC). TQCC is a stand-alone unit employing some of the VisioSafe components for marking and inspection, with optional OCS Checkweighers Inc. support for weight verification.
“Customers can move the TQCC behind the cartoner to implement serialization without touching the rest of the machine,” says Christoph Lehmann, senior manager, VisioTec.
The VisioSafe system from Ulhmann provides a variety of bar codes.
(click image to enlarge)
The VisioSafe system employs the VisioMark laser marking system for package coding, after the database server provides data. One of the most promising code types, the 2-D data matrix code, was demonstrated to serialize single products at WestPack. For optional case and pallet coding, for example, a Wolke m600 digital ink-jet printer can be integrated. Parent-child linkages between serialized items and cases and pallets are established in the database if required by the user.
A VisioRead vision inspection system reads, verifies, and evaluates the data on each salable package and on case and pallet labels, for database storage. Unacceptable packages are rejected. The server can correspond with e-pedigree applications or the company’s ERP systems like SAP for establishing and updating e-pedigree information.
Lehmann says VisioTec is currently building a full-blown VisioSafe system solution for a U.S. customer that is packaging syringes in multiple different-count cartons. The firm will serialize the cartons with 2-D DataMatix codes.
“This is a comprehensive serialization and track-and-trace solution, with 2-D coding at the carton, itemizing case, and pallet, and establishment of parent-child correspondence,” Lehmann says. VisioSafe will deliver the system mid-year for integration into a new line.
Demand for serialization solutions has been growing not only in the United States but also in Europe. Packagers in Italy and Belgium are racing to meet regulations for serialized coding, and track-and-trace requirements are coming soon in Turkey and other countries.
Lehmann says that with RFID misread rates still as high as 5 and 6%, many packagers are favoring 2-D codes, or at least 2-D code-redundancy to RFID.
“The 2-D code is nonproprietary, it’s very robust, it is very redundant (partial codes can be read), and you can put a lot of information in them,” he notes.
Targeted to firms attempting to meet California’s 2009 e-pedigree deadline, the VisioSafe system provides one source for line-level equipment, and complete integration services, says Lehmann.
The solution comes with functional requirement specification and I/Q and O/Q documentation, and is 21 CFR Part 11 compliant.
Since VisioSafe was launched in 2004, companies in Europe have deployed the solution for internal ID and tracking applications. “We have now combined component technologies to offer a more comprehensive solution than has been available in package serialization systems on the market.
“The customer does not have to deal with multiple suppliers,” says Lehmann. “Unlike other solutions, we supply all required ancillary systems like printers, laser marking systems, and optional labeler equipment. We also provide integration for all hardware and software. Retrofitting is performed efficiently, since, as an Uhlmann division, we know the machines.”