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Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, email@example.com.
Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations.
Serialization implementation can become easier, faster, and less expensive with the Open Serialization Communication Standard Group’s (Open-SCS) Packaging Serialization Standard (PSS 1.0). Nine vendors and one end user conducted pilot tests to evaluate the standard, and the validated PSS 1.0 was officially released in November 2017.
The standard is expected to reduce integration costs, which can run into the hundreds of thousands of dollars, by 50 percent, said Adriano Fusco, Open-SCS’s marketing director, and strategy & development director for Antares Vision. Fusco made the remark during a press conference held by the group on Sept. 25, 2017, at PACK EXPO Las Vegas (Sept. 25-27, 2017, Las Vegas Convention Center). Adoption of the PSS 1.0 minimizes customization of plant-to-enterprise interfaces (Levels 3 and 4), thereby shortening the integration process by months and improving scalability and repeatability.
The culmination of more than two years of work by the Open-SCS Group, the PSS 1.0 covers four use cases involving typical communication between onsite servers (Level 3) and corporate repositories (Level 4). It also defines best practices for serial number provisioning, serialization report transmission, batch and master data repository, and unused serial number return (1).
Serialization requires an exchange of data on multiple levels. However, communication is difficult and requires spending a lot of effort on interfaces, Fusco said. Standardization with its common language and templates benefits end users and vendors by dramatically reducing the amount of customization needed. Quicker and easier integration across vendors and facilities expedites compliance with anticounterfeiting regulations worldwide.
Vendor and end-user members of the Open-SCS Group started with the goal of developing functional interoperability of packaging solutions to seamlessly integrate the serialization process. Fusco, added, “Competitors have come together to do what’s right for industry. We have made our knowhow public. In the medium and longer range …we will all benefit-vendors and end users.” Seamless information technology (IT) connections and elimination of customized interfaces not only benefit serialization newcomers, but also serialization veterans who will eventually need to upgrade their IT infrastructure and equipment (2).
Pharmaceutical manufacturers Abbott
Teva Pharmaceuticals Industries
ACG Pharma Technologies
Giesecke & Devrient
Uhlmann Packaging Systems
Vantage Consulting Group,
Werum IT Solutions
Since its founding by 11 firms, the Open-SCS Group has seen its membership more than double. As work continues, Fusco expects membership to continue to grow. In order to streamline the standard development process, the Open-SCS Group works under the auspices of the OPC Foundation, an organization focused on interoperability standards for secure and reliable data exchange for industrial automation. It also collaborates with other organizations such as the International Society of Automation, the International Society for Pharmaceutical Engineering, and GS1.
With official release of the validated PSS 1.0, the Group plans to introduce an OPC-standardized certification process in 2018, which will define what vendors must do to show that their products conform with the PSS 1.0, and how testing must be performed. Although no certifications have been granted yet, Fusco predicted, that most vendors will be able to deliver compliant product “within months.”
Next steps for the Open-SCS Group involve work on Level 2 and Level 3 interfaces. The forthcoming PSS 2.0, targeted for release by the end of the second quarter of 2018, will address nine exchange use cases between Level 3 (site serialization manager) and Level 2 (line serialization controllers and smart devices). “We need funding for subject matter experts,” noted Fusco, adding, “We are looking for more companies to participate.” Work also is proceeding on developing a business model that will help to ensure faster adoption of the standard worldwide.
1. Open-SCS Group, “First Packaging Serialization Standard from Open-SCS Group Showcased at Pack Expo; Release of Validated Standard Planned for November 2017,” News Release, Sept. 29, 2017.
2. Open-SCS Group, “At Pack Expo, Open Serialization Communication Standard Group (Open-SCS) to Announce Major Milestone,” News Release, Sept. 22, 2017.
3. Open-SCS Working Group, https://opcfoundation.org/markets-collaboration/open-scs-working-group/, accessed Oct. 31, 2017.