The Low Down on a New Packaging Serialization Standard

Nine vendors and one end user recently conducted pilot tests to develop, evaluate, and validate a new serialization standard, PSS 1.0, officially released in November 2017. This group, known as the Open Serialization Communication Standard Group (Open-SCS), advocates that 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.

At a press conference at PACK EXPO Las Vegas in September 2017, Adriano Fusco, Open-SCS’s Marketing Director and Strategy & Development Director for Antares Vision, stated the standard is expected to reduce integration costs, which can run into the hundreds of thousands of dollars, by 50 percent.

Involving over two years of work by the Open-SCS Group, 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).

Because serialization requires an exchange of data on multiple levels, communication can be difficult and require 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 anti-counterfeiting 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).

With the official release of the validated PSS 1.0, the Open-SCS 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.” (4)

Member Subscription provides members with the following Work Products and their updates that are continually driven by the evolving global serialization regulations across individual countries:

       1. Packaging Serialization User Requirement Specification (URS) for the proposed use cases
       2. Associated Performance Qualification Tests (PQ) Templates
       3. Two System Functional Requirements Specifications (FRS) Templates for specific line and system configurations
       4. An OPC-UA / ISA-95 / ISA-88 Implementation
       5. An EPCIS Implementation with Standard Healthcare Packaging extensions to the proposed use cases
       6. Associated Operations Qualification Tests (OQ) Templates

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.

The official site can be accessed at:  https://opcfoundation.org/markets-collaboration/open-scs-working-group/

OPEN-SCS Members

Abbott
ACG Inspection Systems
Adents
Advanco
Antares Vision
Arvato Systems GmbH
facilityboss
Giesecke & Devrient
Laetus
Mettler Toledo PCE
Omron Europe
Optel Group
Pfizer
Roche
Rockwell Automation
SAP
Systech
Teva Pharmaceuticals Industries Ltd.
TraceLink
Tradeticity
Uhlmann
Vantage Consulting Group
Werum IT Solutions GmbH
WIPOTEC-OCS

References

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.
4. Hallie Forcinio, “Standardizing Serialization”, Equipment and Processing Report, December 20, 2017

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