After years of development, a new standard for packaging line serialization and aggregation data exchanges will be released later this month at the Pack Expo congress in Las Vegas, US.
The standard – developed by the industry-backed Open Serialization Communication Standard (OPEN-SCS) group and called Packaging Serialization Specification (PSS) 1.0 - comprises "a best-practices approach to serial number provisioning, serialization report transmission, batch and master data repository, and unused serial number return," according to the organization.
The initial standard covers four use cases involving typical communication between Levels 3 and 4 of the serialization infrastructure – namely, between manufacturing or packaging site servers and corporate repositories. It will serve as the basis for PSS 2.0, which is due for publication next year and will address nine exchange use cases between Level 3 (site serialization manager) and Level 2 (packaging line serialization controllers and smart devices).
Ultimately, the goal is to reduce the risks and cost associated with serialization projects, and enable efficient, flexible, and scalable track and trace programs that can be integrated across diversified serialization systems and intelligent devices, leveraging the use of other global standards such as those developed by coding specialist GS1 and the automation-focused OPC Foundation.
"For the global pharmaceutical industry, the lack of a standard in trace and trace-related communication has posed significant constraints on implementing workable serialization solutions," said OPEC-SCS. Its executive director and IT business relationship manager at Abbott' Marcel de Grutter, said that with the initial standard now finalized "we are hoping for its expedient adoption across the industry."
"As various serialization deadlines approach – including those in the US (November 2017) and EU (February 2019) – establishing baseline language compatibility has become increasingly urgent."
The organization acknowledges that many packaging lines in the pharma industry have already been upgraded to handle serialization but says the standard "is more than relevant as the IT infrastructure and equipment are not static and will need to be upgraded in the future."