Serialization Implementation

Serialization Implementation

Background:

Due to the regulations made by the Drug Supply Chain Security Act Law (DSCSA) and the U.S. Food and Drug Admiration (FDA), all pharmaceutical manufacturers are required to serialize the prescribed products that are going to be distributed on the United States.  These requirements can make a huge impact on small companies that do not have the technology infrastructure and operational protocols. Integrated Commercialization Solutions (ICS) wanted to bring serialization services to its clients and help them achieve this new challenge.

Challenge:

As a Contract Manufacturer (CM) and Third-Party Logistics (3PL) provider, ICS faced huge challenges to provide a serialization turn-key solution for its clients.  They needed a fast and reliable solution that was in compliance with U.S. regulations. The goal was to implement a serialization program from scratch in three (3) different sites around the United States.

Solution:

Ultimate Solutions Corp. proposed a complete package that covered their needs.  In this package was included a semi-automated line with serialization solution and validation services.  A corporate strategy was created for the validation of the new equipment, software, and a serialization program that was aligned to ICS needs.  In their three (3) sites were installed a series of serialized ready machines from our brand protection division, UPAK Global. At Kentucky, were installed a U-Track FCG2, a U-Pack SCG2, and a U-Pack SA.  In Ohio and Nevada was installed a U-Pack SA machine.

The U-Track FCG2 is a machine designed for primary package serialization, capable of managing small to large production lot sizes.  This print and inspect module provided a great solution with the utmost control and safety on the serialization process. The U-Pack SCG2 is a semi-automated pack-by-layer (PBL) with manual label application.  This machine is designed to be an aggregation module with no-tool, quick change over, and adjustable solution on the packaging line. The U-Pack SA is a manual serialization module that prints, inspect, and aggregates in the same process.  This equipment provided a high-mix low-volume system that covers all ICS needs in a small enclosure. As part of Systech UniSolve program, these machines provide print and inspect, serialization and aggregation. The equipment versatility benefit ICS for its flexibility and simplicity that follows the U.S. and Global regulations.  In combination with the equipment, the serialization program was implemented with Systech’s fully integrated L1 to L4 solution. This combines the equipment interphase, line management, site management, and enterprise connectivity for more flexibility and hassle-free customization. To complete the project scope, our validation team made all the required documentation and execution for machine and serialization software validation with a robust qualification strategy, following the validation life cycle approach.  ICS personnel and operators from all sites had hands-on training on Systech’s software and machine configuration settings.

Benefits:

The client was able to obtain the results needed to comply with the U.S. regulations in a time-saving and cost-effective method.  Thanks to USC expertise the project was completed using a single point of contact and covering all the client’s needs. Nowadays, ICS is ready to fulfil its clients’ needs and are a strong competitor to other CMO’s and 3PL’s.

“Ultimate Solutions Corp. provided the Upak serialization and aggregation equipment, a fast and cost-effective solution to support commercialization of serialized pharmaceutical products.”

– ICS

Author: Jahzeel Rosado, Project Engineer

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