Grand River Aseptic Manufacturing, Inc. Implements Fully-Automated Serialization and Aggregation Solutions Ahead of 2023 DSCSA Deadline

April 30, 2019 Off By BusinessWire

GRAND RAPIDS, Mich.–(BUSINESS WIRE)–Grand
River Aseptic Manufacturing, Inc. (GRAM)
, a leading 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 (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.

To learn more about GRAM and its ongoing expansion, visit grandriverasepticmfg.com.

About Grand River Aseptic Manufacturing, Inc.
Grand River
Aseptic Manufacturing, Inc. (GRAM), a parenteral contract development
and manufacturing organization, delivers customized solutions to meet
clients’ fill and finish needs from development through
commercialization. With capabilities for biologics as well as controlled
substances, GRAM’s expert project managers and modern facilities support
pharmaceutical development and cGMP manufacturing, analytical testing
and regulatory filing. For more information, visit grandriverasepticmfg.com.

Contacts

Nicholas Bartosik
Grand River Aseptic Manufacturing, Inc.
616.678.2400
x243
[email protected]