On Monday, Sept. 25 at 1:00pm, Organization of Industry Leaders Will Announce Initial Serialization Standards, including Protocols for Communication between Levels 3 & 4

The Open Serialization Communication Standard (OPEN-SCS) Group, a collection of healthcare sector companies dedicated to standardizing packaging line serialization and aggregation data exchanges, is set to announce a major milestone in the push to streamline global track & trace processes. At Pack Expo, the organization will hold a press conference to formally introduce its initial Serialization Standard. Packaging Serialization Specification 1.0, the achievement will be revealed in detail on September 25 at 1.00PM at the show's Media Briefing Room S226.

For Open-SCS, the group's first recommendations for far-ranging 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. Specifically, Packaging Serialization Specification 1.0 comprises a best-practices approach to Serial Number Provisioning?, Serialization Report Transmission?, Batch & Master Data Repository?, and Unused Serial Number Return.  PSS 1.0 work was done in direct collaboration with ISPE and GS1 Global technical experts.  It is the foundation for the PSS 2.0 work to address 9 exchange use cases between Level 3 (site serialization manager) and Level 2 (line serialization controllers and smart devices).  PSS 2.0 has targeted release of Q2 2018.

At the Pack Expo press conference, group leaders will detail these initial achievements, as well as plans to ensure their timely and widespread adoption.  The group's next steps, including additional milestones, also will be discussed.

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.

Even though many packaging lines are already equipped with serialization equipment, the OPEN-SCS standard is more than relevant as the IT infrastructure and equipment are not static and will need to be upgraded in the future. The current level of customization costs a lot to the industry and OPEN-SCS major objective is to make the IT connections seamless and put an end to the customizations.

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.  

Marcel de Grutter, Executive Director of the Open-SCS Group, noted that "This important announcement follows more than two years of committed collaboration by our technical group.  I would like to thank all the team members who dedicated so much time and effort to this initiative, often working far more than their allotted hours. Now that the initial standard is released, we are hoping for its expedient adoption across the industry: that will be our next challenge".

Companies seeking more information, or who wish to join the Open-SCS Group, can contact its Marketing Director, Adriano Fusco, at [email protected].