CDMO Speeds its Line with Open-Source L4 Serialization System

With the serialization deadline approaching, Sovereign Pharmaceuticals implemented open-source software that allows the company to make their own changes and improve packaging efficiency.

Sovereign implemented serialization and aggregation on all three configurations of packaging lines at once.
Sovereign implemented serialization and aggregation on all three configurations of packaging lines at once.

Sovereign Pharmaceuticals, LLC is a CDMO specializing in small-batch prescriptions drugs, packaging solid and liquid products in their Ft Worth, TX, facility. They handle a variety of bottle sizes—from 50 cc up to 950 cc and from 1 oz to 16 oz—for a number of drugs and indications. Dealing with several virtual companies for clients, they spend a lot of time educating them about regulatory requirements.

In 2016, the company sought a serialization solution to meet the DSCSA enforcement date in Nov. 2018. While they were driven by regulations, meeting the deadline appeared it would be a challenge. “We tried one solution and our customers tried three other solutions and none of them were going to meet the deadline,” says Ryan DeSario, Serialization Supervisor at Sovereign.

L4 hurdles

L4 connectivity proved to be an obstacle with the approaching deadline. “In February 2018, we received our equipment and we’d been working to make the connections. It was supposed to take six weeks but by the end of July 2018, we were still working on the connection,” says Paul Hafey, President and CEO at Sovereign.

QU4RTET provided a cost-effective open-source L4 system allowing Sovereign to connect with trading partners like Tracelink, rfXcel, and SAP systems.QU4RTET provided a cost-effective open-source L4 system allowing Sovereign to connect with trading partners like Tracelink, rfXcel, and SAP systems.

Sovereign had Antares hardware designed for small manufacturers with ID Technology pieces installed. “All of that worked and communicate with each other and sent numbers through the system,” explains Hafey. “The Antares system has the ability to create its own serial numbers, but the issues we were encountering were pulling serial numbers from our customers using a L4 to send the serial numbers into our system and then sending the aggregated serial number back to our customers L4 via EPCIS.

“We were already working with Vantage Consulting Group—they’d helped us with our equipment. When we started having trouble making connections to our customers’ L4 systems, they asked if we would like to try QU4RTET which is an open-source program. Vantage was an early adopter of QU4RTET and was familiar with integrating it,” says Hafey. “They said they could get the connections in place by the November 2018 deadline and they did.”

QU4RTET provided a cost-effective open-source L4 system allowing Sovereign to connect with trading partners like Tracelink, rfXcel, and SAP systems. With an open-source platform, Sovereign “owns” and implements the system, and can add the features it wants.

Implementation of QU4RTET began at the start of August 2018 and took about four to six weeks for Sovereign to connect to partners who were prepared. The pair note that some customers were not as up-to-date on the regulations and requirements at the enforcement time. Hafey explains, “The advantage was that the Antares hardware with the QU4RTET software allowed Sovereign to handle the DSCSA requirements for those clients while they selected an L4 system. If they wanted to use a different system, we could dump all the serial numbers to them once they were connected.”

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