TheOpen Serialization Communication Standard (OPEN-SCS) Group, a collection of healthcare sector companies dedicated to standardizing packaging line serialization and aggregation data exchanges, presented its initial Packaging Serialization Standard (PSS 1.0) on September 25 during PACK EXPO Las Vegas. The release of a validated standard is planned for November.
Following two years of intense collaboration among committee members,Antares Vision“开放式SCS集团的营销总监Adriano Fusco，共享摘录文档，示例了标准，以及当前正在供应商之间进行的测试矩阵。
The Open-SCS Group’s initial set of recommendations for serialization standardization cover four use cases involving typical communication between Levels 3 and 4 of the serialization infrastructure—between onsite servers and corporate repositories. PSS 1.0 comprises a best-practices approach to Serial Number Provisioning, Serialization Report Transmission, Batch & Master Data Repository, and Unused Serial Number Return.
Work to create these first specifications was done in direct collaboration withISPE和GS1global technical experts, and is the foundation for the forthcoming PSS 2.0, which will address nine exchange use cases between Level 3 (site serialization manager) and Level 2 (line serialization controllers and smart devices). PSS 2.0 is targeted for release in Q2 of 2018.
For the global pharmaceutical industry, the lack of a standard in track-and-trace-related communication has posed significant constraints on implementing workable serialization solutions. As various serialization deadlines approach— including those in the U.S. (November 2017) and EU (February 2019)—establishing baseline language compatibility has become increasingly urgent.
To address this need, the Open-SCS Group was founded two years ago by leading serialization solution vendors and global pharmaceutical manufacturers, including Abbott, Advanco, Antares Vision, OCS, Optel, Omron, Pfizer, Roche, Systech, Teva, TraceLink, Werum as founding members. The group now includes more than 25 member companies.
The next steps for the Open-SCS Group, as discussed at its recent meeting in Holland, hosted by Abbott Laboratories, include:
•运行试点项目以测试各种供应商平台之间的通信。
•设置用于扩展3级（站点序列化管理器）和4（企业存储库）之间的使用情况的里程碑，以及2级（案例/包装线自动化和控制）和级别3之间的通信。
• Developing a business model that will ensure quick adoption of the standard worldwide.
• Drafting the certification process to ensure full compliance of products arriving on the market.
The first standard-compliant products will be introduced in the near future, noted Fusco, and would be produced by several Open-SCS Group member vendors whose research and development teams have been involved in the standard definition.
Fusco also discussed how in-depth tests of the standardized interfaces have been ongoing over the last 12 months at various vendor facilities, helping to ensure the development of a standard in line with the functional needs of the market.
Fusco praised the work and dedication of Marcel de Grutter, Executive Director of the Open-SCS Group, as well as the collaborative efforts of the working team, for devoting their free time to meet the group’s deadlines.
