A premier, fully configurable drug serialization and aggregation software solution from Adents was successfully installed on seven packaging lines at four France sites for a top European pharmaceutical contract manufacturer. With a dozen production sites, the CMO requested short-term implementation to serialize saleable units for four markets – China, South Korea, Brazil and the U.S. – along with the ability to upgrade the installation to embrace pending track & trace mandates in 10 other countries.
Adents serialization solution is hardware agnostic, meaning it is compatible with a wide range of equipment. This was a key selling point for the CMO, which plans to equip as many as 80 lines to address increased demand as serialization deadlines in America and Europe approach.
The Adents serialization and aggregation suite enables companies to achieve traceability and documentation compliance easily, addressing both current and emerging regulations while also minimizing impact on production processes and productivity.
For implementation, the CMO established a two-level decision-making organization: a group leadership team to manage procurement and global governance, and serialization project management teams at each site. Here, the Adents solution, by its nature, helped make for a smooth incorporation; an ideal “standardized software” approach, Adents is extremely flexible, scalable, and quick to deploy because its configuration takes place completely at the site level, making per-line configuration unnecessary.
So Many lines, so few similarities…
In its effort to realize a workable, forward-thinking serialization solution, the CMO faced a challenge that nearly any pharmaceutical manufacturer its size would face: the lines being outfitted had a wide array of differing specifications. The large company’s packaging operations were unsurprisingly diverse, running the spectrum from manual lines producing 40 items per minute to semi-automatic operations churning out 300 units/min.
Here again, the hardware-agnostic Adents solution made implementation far more manageable than it could have been. The CMO was able to leverage existing equipment as much as possible, allowing the company to optimize its project budget, reduce training and documentation, and simplify support and vendor management.
Of note, five lines were already equipped with H2M and Seidenader modules, so the remaining two lines that required additional equipment were outfitted with new H2M modules for continuity’s sake. Adents’ software solution also supports a wide range of requisite add-on devices from a broad array of brands; the CMO chose machines from Domino, Zebra, Keyence, Cognex and Omron vision systems with the reassurance that, via the Adents software, all would work well together to form a comprehensive serialization solution.
Fast and Fastidious Results
The first line was installed in 2.5 months, much of which comprised arrival and installation time for the aforementioned new equipment. The remaining steps included:
Documentation (project quality plan, functional analysis, protocols): 1 month
Set-up and qualification by machine builder (FAT & SAT): 2 weeks
Set-up in client plant by Adents (configuration and installation): 1 week
Qualification in Adents office (FAT): 1 week
Qualification in client plant (SAT): 1 week
Each of the other lines was incorporated in less than 6 weeks. A rework station was set up on each line as well. Because a comprehensive FAT was performed by Adents upfront, line downtime was reduced to a maximum of one week for new qualification (SAT/IQ/OQ/PQ), significantly minimizing the impact on production capabilities.
In all, seven lines were installed at four different sites in France for this CMO, with ten different packaging formats enabled on a single line. The client now provides serialized production services for at least four big pharmaceutical companies and has the capacity to address larger demand and a variety of expanded customer requirements.
Adents is a leading provider of premier serialization software solutions for unique product identification and traceability. Adents helps pharmaceutical companies and contract manufacturing organizations (CMOs) adapt to market changes and comply with regulations on drug traceability.
Adents Seriza, a serialization solution for manufacturing sites, has been selected as a preferred solution by Siemens for its customers. Adents Prodigi, a cloud solution jointly developed with Microsoft and powered by Azure technologies, allows for secure data exchange and helps leverage the power of serialization data.
Adents operates globally, with offices in the United States, Europe and Asia and with a worldwide network of solution partners.
Macallan Whisky picks Izon® Technology as part of a comprehensive anti-counterfeit solution
(De La Rue Authentication Solutions)
The Edrington Group, makers of world renowned The Macallan Highland Single Malt Scotch Whisky, faced a challenge when re-filled used
bottles, intact with labels, began appearing on shelves under their brand name. This posed a serious consumer safety, as well as a global
brand issue. For a solution, they turned to Authentication Solutions for the key overt component of a comprehensive solution.
Epson builds market awareness of authentic product through implementation of layered AC tech
(De La Rue Authentication Solutions)
Epson Latin America estimated that 20% of the product in the market was counterfeit and entering the supply chain through local distributors. The existing anti-counterfeiting ink technology was compromised. Epson developed a new strategy to target unauthorized distributors in key countries and build market awareness of authentic product.
The StellaGuard™ solution leverages the benefits of a barcode and connects it with a three-dimensional visual reference that provides instantaneous authentication with copy-detect protection. StellaGuard™ is a patented and elegant solution to protect your assets, enabling trusted stakeholders, including customers, to authenticate a product using common everyday smart devices.
The smartphone: a new tool to spot fake products
The development of new smartphone technologies offers brands the opportunity to fight counterfeiting more efficiently and drive competitive differentiation by turning their products into smart assets. This paper examines the process of placing the consumer as one of the key actors against illicit trade and creating new business intelligence capabilities for brands.
Pharma Security World 2018: "Anti-counterfeiting and Brand Safety"
March 20-21, 2018 - London, UK
Global Illicit Trade Summit 2018: Out of the shadows
March 22, 2018 - Kuala Lumpur
4XScience 2018 E2E Supply Chain Serialization Benchmark Workshop
March 27-28, 2018 - Brussels, Belgium
Robert Schuman Foundation conference: Smuggling, counterfeiting and the financing of terrorism – mobilising economic stakeholders
April 11, 2018 - Brussels, Belgium
April 17-19, 2018 - New York (NY), USA
4th Global Brand Protection EU Innovation Programme (GBPIP)
April 26-27, 2018 - London, UK
IACC 2018 Annual Spring Conference
May 16-18, 2018 - Seattle (WA), USA
May 29 - June 01, 2018 - Milan, Italy
Partnership for Safe Medicines 2018 Interchange
June 07, 2018 - Washington D.C., USA
June 25-27, 2018 - London, UK
September 2018 (dates tbc) - Switzerland
Rx-360 Global Life Science Supply Chain 2018 Conference: Driving Innovative Quality Strategies
September 25-26, 2018 - Miami (FL), USA
2018 A-CAPP Center Brand Protection Strategy Summit
October 02-03, 2018 - East Lansing (MI), USA
13th Security Document Summit (SDS)
October 17-18, 2018 - Beijing, China
Anti-Counterfeit & Currency Expo (ACCE)
November 06-08, 2018 - Las Vegas (NV), USA