Concern over the proliferation of counterfeit pharmaceuticals is prompting manufacturers to implement serialized packaging to support full traceability, product integrity, supply chain security and patient safety. Conventional serialization solutions multiplex industrial cameras from an industrial computer (PC) to distribute vision at multiple points on the production line. Maintenance and validation of these systems can be expensive because of the need to deal with a complex operating system and custom software. Another challenge with existing systems is the cost and footprint required to serialize round, un-oriented bottles that frequently require labelers to position many cameras around the bottle in order to read the label.
Körber Medipak's Seidenader subsidiary, one of the leading suppliers of pharmaceutical serialization solutions, has addressed these challenges by developing a serialization solution based on the use of smart cameras. Seidenader’s Process Manager line-level serialization software is designed to configure and manage the Cognex smart camera technology, substantially reducing administration and validation expenses of the vision technology. Just a single industrial computer at the line-level provides the necessary recipe management, security and audit trailing for all camera stations on the packaging line.
Körber Medipak has also addressed the aggregation challenge of inspecting 2-D codes on round bottles. With Process Manager 360, bottles can be read on-the-fly, capturing a 360 degree view of an un-oriented bottle. Due to the small footprint of this solution, the inspection station can be integrated anywhere on the packaging line; including the out-feed of a labeler, or in-feed of a bundler or case packer at speeds up to 400 bottles per minute.
Addressing the danger of counterfeit pharmaceuticals
The World Health Organization estimates that 10% to 15% of the world’s drug supply and probably on the order of 1% in the United States is counterfeit. Substances such as cement, talcum powder, sawdust, industrial solvents and paint have been substituted for the active ingredients of dozens of drugs. Robert Bate, author of Phake: The Deadly World of Falsified and Substandard Medicines, estimates that more than 100,000 people are killed worldwide by counterfeit and substandard drugs every year1. In a recent highly publicized incident, counterfeit versions of the anti-cancer drug Avastin entered the supply chain in the United States and reached the hands of dozens of doctors across the United States2.
Regulators around the world have been working for years to develop a standard for a secure electronic chain-of-custody for pharmaceuticals, often called ePedigree. Within a few years, ePedigree requirements are expected to impact all pharmaceutical plants around the world. Even though all regions have not yet enacted ePedigree legislation, manufacturers exporting into regulated markets must adapt their packaging to conform to specific regulations even when the product is produced in jurisdictions that have not yet imposed traceability requirements.
Nearly all pharmaceutical manufacturers are addressing these challenges by working on implementing serialization solutions that will affix a unique and traceable serial number on every package, bundle, case and pallet. This approach to accomplish an ePedigree solution will provide an electronic record of the entire product cycle that provides accurate and complete information about each transaction within the supply chain, making it possible to easily and quickly verify the authenticity of each pharmaceutical product.
Earlier generation solutions
Körber Medipak’s Seidenader subsidiary is a leading global supplier of serialization solutions for pharmaceutical packaging lines. Körber Medipak’s original serialization solutions utilized vision systems consisting of a camera, an image processing card and image processing software running on an industrial PC. Industrial PC-based vision systems require IT department oversight, service pack updates, and other items like virus protection software. In addition, PC technology changes rapidly so that in as little as one year after installation, it can be difficult to source and configure a new PC with the same specifications as those currently used on the line.
The PC based vision system used in the past took considerable time and effort to integrate because they required considerable vision expertise and possibly, knowledge of low-level programming languages. This can be very expensive in today’s regulatory environment because the path to serialization compliance remains unclear with current data formats and marking standards varying from country to country and region to region. Furthermore, production changes require possible code rewrites to the technology, and costly equipment upgrades to the packaging lines. The overall application software, hardware, and operating system for each vision system always require to be validated to meet FDA requirements, which is an expensive process in itself.
Benefits of smart camera based solutions
Seidenader worked with Cognex to develop a new serialization software solution taking advantage of In-Sight® smart camera technology. The new line-level software requires only one industrial computer per line to manage the security and recipes for the smart cameras as well as audit trail all tool-set and threshold changes within the software itself. This smart camera based solution provides pharmaceutical manufacturers with a lower cost of ownership because the vision operates independently of the computer operating system, is inherently much more stable over time and is not subject to yearly computer obsolescence issues. This approach makes it easy for the end-users to find “like for like” camera replacements for many years after initial installation, and to maintain consistent vision performance across multiple inspection points and packaging lines.
The new Seidenader serialization solution requires much less effort on the part of the customer’s IT department when managing plant wide computer updates and virus protection. The Seidenader serialization solution is also less expensive to implement because the Process Manager vision interface provides access to the Cognex high level tools that reduce the time and expertise required to develop the vision application and customize the solution to meet specific customer needs.
Supporting global pharmaceutical manufacturers
Process Manager standard verification inspections are designed to parse the data matrix serial number in real-time, automatically populating the human readable toolset and provide verification and match functionality. The vision I/O is managed via the Process Manager industrial computer platform, not a separate vision I/O board.
“We selected Cognex as our vision technology partner because Cognex is the technology leader in the vision industry,” said Leonard Valeo, Serialization Solutions Sales Manager for Körber Medipak. “In fact Cognex spends more on research and development than many of their competitors have in sales. Cognex also can support their products around the world which is important because the larger pharmaceutical companies are global in scope and they prefer to standardize on a single serialization solution, including a strong vision platform.”
The Seidenader solution can provide item, bundle, case and/or pallet serialization throughout the packaging process. All serialization processes, equipment interfaces, printing stations, cameras and/or bar code readers are managed and controlled by Seidenader’s Process Manager software; ultimately creating and documenting the proper parent-child aggregation relationship at the line-level. Process Manager controls and maintains parent to child relationships, while associating and documenting the alias of each serial number along the way. A localized repository manages the real-time allocation of numbers, associations, and status updates as related to the batch.
Seidenader also provides browser-based site-level serialization software that provides the proper gateway between the packaging lines and the end-users ERP/MES environments. This software called MLS, interfaces with the L3 and L4 layers to manage client material master data and Production Orders automatically with the site-level serialization processes.
360 degree inspection with two barcode readers
Seidenader has introduced a new 360 degree inspection station whose cost and complexity is reduced by using only two Cognex DataMan® ID readers utilizing the VSoC™ vision chip. VSoC technology enables DataMan to offer unprecedented speeds on 1-D barcode reading with up to 90 decodes per second and ultrafast image acquisition with auto-exposure, at up to 1,000 frames per second.
By using a simple bar code reading architecture, engineered with a proprietary LED lighting and mirroring design, Process Manager 360 can verify data matrix codes printed on round bottles at high speeds, with minimal to no false rejects.
Process Manager 360 is an affordable solution that is based on an “open-view” design, so operators and mechanics can actually see the inspection process occur. Process Manager 360 requires minimal adjustment based on bottle height and diameter and can be maintained without the need of machine vision expertise.
Seidenader is currently working with several global pharmaceutical manufacturers to implement their new serialization solution and expects to have their first customers up and running early in 2013. “Customers are excited about utilizing our smart camera technology approach to help reduce the cost of implementing and maintaining serialization solutions,” Valeo said. “They are also excited about the dramatic reduction in cost and footprint for inspecting round bottles in complex aggregation applications. We are very pleased to be partnering with Cognex to deliver these benefits to the global pharmaceutical industry.”
1Henry I. Miller, “Fake And Flawed Medicines Threaten Us All,” Forbes Magazine, July 25, 2012.
2Christopher Weaver and Jeanne Whalen, “How Fake Cancer Drugs Entered U.S.,” Wall St. Journal, July 20, 2012.