Grand River Aseptic Manufacturing (GRAM) 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 (DSCSA).
The DSCSA was signed into law in November of 2013 to reduce the spread of counterfeit drugs. The legislation outlines steps to build an electronic system to track and trace prescription drugs as they are manufactured and distributed throughout the supply chain. Implementation of the requirements in the bill began in 2014, and the final requirements for complete unit level traceability and aggregation will be phased-in through 2023.
A critical component to the implementation of serialization and aggregation at GRAM was the recently completed qualification of the company’s new, fully-automated Marchesini packaging line. The state-of-the-art 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. 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,” said Steve Nole, Vice President of Operations at GRAM. “This flexibility allows GRAM to meet the diverse regulatory requirements not only within the U.S. market but throughout the world.”
The investment in the Marchesini packaging line is just one of the many systems and process advancements GRAM is implementing in parallel to the construction of a new, advanced aseptic manufacturing facility. The state-of-the-art facility ensures that GRAM is well positioned to provide its customers with a single source for clinical to commercial scale aseptic manufacturing and final packaging.
Construction of the expansion is currently underway and will house two state-of-the-art cleanrooms equipped with isolator technology. The $60 million investment represents the most significant expansion in company history and more than doubles its current square footage. The facility is slated for completion in the second half of 2020.