Today, the Open Serialization Communication Standard (OPEN-SCS) Group, a collection of healthcare sector companies dedicated to standardizing packaging line serialization and aggregation data exchanges, will announce a major milestone in the push to streamline global track & trace processes. At Pack Expo in Las Vegas, the organization will hold a press conference to formally introduce its initial Serialization Standard, the Packaging Serialization Specification (PSS) 1.0. The achievement is to be revealed in detail today at 1 PM at the show’s Media Briefing Room S226.
The OPEN-SCS group’s first recommendations for far-ranging serialization standardization covers four use cases involving typical communication between Levels 3 and 4 of the serialization infrastructure—that is, 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.
OPEN-SCS is a subgroup of the OPC Foundation and the new standard makes use of OPC-UA to provide standardized security and connectivity layers. I’ve written about OPEN-SCS before (see “The Open Serialization Communication Standard (Open-SCS)” and “Serial Number Bonding”).
PSS 1.0 was developed in direct collaboration with the OPC Foundation, ISPE and GS1 Global technical experts. This initial release of the standard will serve as the foundation for the next version, targeted for release in Q2 of 2018. PSS 2.0 will address 9 exchange additional use cases between Level 3 (site serialization manager) and Level 2 (line serialization controllers and smart devices).
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, will also be discussed.
For the global pharmaceutical industry, the lack of a standard for communications between layers of a serialization solution has posed significant constraints. As various serialization deadlines approach—including 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 results in higher costs so a major objective of OPEN-SCS 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, Optel, Omron, Pfizer, Roche, Systech, Teva, TraceLink, Werum, and WIPOTEC-OCS 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“.
It has been my pleasure to be a member of the OPEN-SCS working group, serving on its steering committee, since its inception. Anyone who has worked on a communications standard of any kind knows how difficult it can be to get consensus and move the ball forward. This group is like that, but the thing that held us together and moving forward was the importance to our end-users: drug manufacturers, repackagers and contract manufacturers. OPEN-SCS will allow those companies to retain their investments in existing solutions (once they are upgraded to include certified OPEN-SCS interface software) whenever acquiring sites that make use of solutions from a different vendor. And for the first time, drug manufacturers will be able to make use of a standardized security layer to minimize the chance that malware and ransomware can move from system to system—even in a mixed vendor environments.
Drug manufacturers, repackagers and contract manufacturers should watch for the OPEN-SCS interface to be offered as an option in their existing solutions at their next major software update for L3 and L4 components, and in the second half of next year for the L2 and L3 components. You should strongly consider taking that option when it is offered.