Grand Rapids’ Grand River Aseptic Manufacturing, a parenteral contract development and manufacturing organization, has implemented its fully-automated serialization and aggregation processes for commercial injectable drug products.
The implementation comes four years ahead of the November 2023 deadline outlined in the Drug Supply Chain Security Act.
The act was signed into law in November 2013 to reduce the spread of counterfeit drugs. It also outlines the steps to build an electronic system to track prescription drugs as they are manufactured and distributed through the supply chain.
Implementation of the bill’s requirements began in 2014, and the final requirements for complete traceability are scheduled to be phased in through 2023.
Grand River’s new, fully automated Marchesini packaging line helped with the serialization and aggregation. The equipment processes up to 300 units per minute and offers simple changeover and minimal maintenance.
“The new Marchesini packaging line offers customers high-speed packaging through cartoning, printing, bundling, and case packing,” says Steve Nole, vice president of operations at Grand River. “The integrated SEA Vision serialization software, in conjunction with the TraceLink Level 4 software, allows GRAM and its customers the flexibility to create aggregation hierarchies through multiple levels of packaging. This flexibility allows GRAM to meet the diverse regulatory requirements not only within the U.S. market but throughout the world.”
The company is also constructing an expansion that is slated for completion in the second half of 2020. It will house two cleanrooms equipped with isolator technology. The $60 million investment will more than double the facility’s square footage.
Grand River has capabilities for biologics and controlled substances.