The Open 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 at a press conference during Pack Expo Las Vegas. Release of the validated standard is planned for November 2017.
Following two years of intense collaboration among committee members, Adriano Fusco, Marketing Director of the OPEN-SCS group, shared excerpted documentation exemplifying the standard, along with a matrix of the tests currently being conducted among vendors.
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 – namely, 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 with ISPE and GS1 global 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 trace & trace-related communication has posed significant constraints on implementing workable serialization solutions. As various serialization deadlines approach – including those in the US (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 over 25 member companies.
Next steps for the Open-SCS Group, as discussed at its latest meeting in Holland, hosted by Abbott Laboratories, include:
- Running a pilot project to test communications between various vendor platforms.
- Setting milestones for the extension of use cases between Levels 3 (site serialization manager) and 4 (corporate repositories), and communication between Level 2 (case/packaging line automation and control) and Level 3.
- 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.
Several questions were posed by media attending the press conference, including inquiries as to when the first standard-compliant products will be introduced. Fusco noted that this will occur in the very near future, and would be produced by several Open-SCS Group member vendors whose research and development teams have been deeply involved in the standard definition.
Fusco went on to discuss 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.
Finally, 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, who often worked long hours on their free time to meet the group’s deadlines.