Serialization Standardization

What?

The Open Serialization Communication Standard (Open-SCS) Group is a collection of vendors and pharmaceutical manufacturers that aims to standardize packaging line serialization and aggregation data exchanges. The group is currently drafting a core set of industry-wide serialization standards. Other standardization bodies already exist, such as GS1, but the goal of the Open-SCS Group is to cooperate with such organizations.

“We have set up a perimeter to ensure we are in synergy with other standardization bodies. This avoids redundancy, overlap and, of course, potential conflict that could confuse or otherwise obscure the serialization standardization initiative,” says Adriano Fusco, Marketing Director at Open-SCS.

Why?

A wave of serialization regulations are about to hit the pharma industry, prompting a frenzy of activity in dozens of countries in terms of implementing track and trace systems. The problem, however, is that everyone is working to different standards.

“A serialization platform involves different levels of automation and data exchanges, spanning from devices, such as cameras, printers and labellers, to the interfaces between production and packaging lines and site managers, enterprise resource planning, global repositories… and all the way up to any mandatory reporting to various regulatory bodies,” says Fusco. “The lack of common standards has meant that data exchanges are designed any time a new system is implemented, often involving different vendors for the four levels of serialization (equipment, packaging line, site operational management and enterprise serialization functions).”

Fusco adds that the group will be prioritizing the most “typical” serialization use cases. For example, one important area of focus is addressing the interface between plant systems and enterprise systems. “These are the most urgent because they affect the relationships between third party manufacturing companies and pharma companies,” says Fusco.

How?

Within the Open-SCS Group, both vendors and companies are collaborating to define the problems and find solutions. “The last technical meeting, held in Princeton, was incredibly productive, as senior experts of competing vendors were sitting side by side – all cooperating for a common goal and contributing with material that often contains their proprietary know how. That’s no small feat in the pharma industry,” says Fusco.

The most recent meeting took place in September 2016, and focused on a review of prototype OPC-UA interfaces, the draft of the OPEN-SCS OPC-UA Companion Specification and the whole information model. The steering committee also discussed the next steps, with a particular focus on the areas where the next regulation will be enforced.

“One of the issues Open-SCS is working to address is making data exchanges pre-defined which, besides making the whole track and trace implementation process less confusing in general, will allow solutions from different vendors to work more synergistically,” says Fusco. “We have welcomed several new members in the past few months, including some very large vendors and pharma companies, and we are proud to say that most of the industry’s leading vendors are represented.”