Serialization Support

Serialization Support

Background:

Neos Therapeutics is dedicated to help their patients who struggle with attention deficit hyperactivity disorder (ADHD) and other central nervous systems (CNS) conditions.  To continue their mission, they had to comply with regulations made by the U.S. Food and Drug Administration (FDA) and the Drug Supply Chain Security Act Law (DSCSA). These regulations require that all pharmaceutical manufacturers are required to give a unique code to the prescribe products that are going to be distributed in the United States.

Challenge:

Like other pharmaceutical companies, Neos Therapeutics was facing big challenges to comply with the U.S. regulations.  They wanted to transform one of the packaging lines and include new equipment for another line. The biggest challenge was to implement the serialization program in a tied schedule with a low-cost solution.

After the project completion, for over a month, they started to struggle with the machine and software setups during the packaging production lots.  This started to create a concern to the personnel and needed to address the issue as soon as possible.

Solution:

Our partner Systech was reached by Neos to implement their serialization software and hardware.  As part of the UniSolve solution Systech presented them our brand protection division machines, UPAK Global.  On site were integrated one (1) U-Track FCG2 and two (2) U-Pack SCG2 with print and apply machines. The U-track FCG2 is a serialization machine that is designed for primary package serialization.  The machine can manage small to large production lot sizes in a multi-format configuration. However, due to current line setup, the normal configuration of the machine didn’t accomplish the task. Therefore, our designers modified the standard machine to meet the requirements of the client.  The U-Pack SCG2 that was implemented was a semi-automated pack-by-layer (PBL) with automated label application. The machine is designed to be a multi-format aggregation module for easy use. All the equipment documentation was created by our experts and delivered to the client.

As part of the serialization solution, Systech’s L1 to L4 solution was integrated.  This solution combines the device interphase, line management, site management, and enterprise connectivity in one simple solution.  This gives the client a flexible and hassle-free customization for current and new products.

After a few months of the project completion, they started to struggle with the machines and software. They contacted us with the need of help and our expert team responded within a few hours with the solution.  We started to give them remote support from our facilities in Puerto Rico. However, for over a month they faced issues on one of the packaging lines and within a couple of days, Ultimate Solutions responded by sending a resource to give them on-site support in Texas fixing the problems in just 3 days.

Benefits:

The serialization program was successfully implemented within the time schedule and meeting all the requirements.  With the remote service support, Neos could address the issues within hours avoiding unnecessary downtimes on the packaging lines.

“Thank you very much… 

We are finally able to breathe a little easier after all of Ultimate Solutions support.”

-Neos

Author: Jahzeel Rosado, Project Engineer

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