Serialization Project

Serialization Project

Background:

Boehringer Ingelheim (BI) – Barceloneta, PR (formerly Merial) found themselves in need to replace their current serialization system.  This solution had to be fabricated, installed, validated, and “in use” within six months since the project inception.

BI, being one of the largest pharmaceutical manufacturers, wanted to align all their serialization systems across all sites. Because of the successful use of more than 40 Systech systems in other sites, it was the obvious choice for their newly acquired sites, including BI, PR. 

Challenge:

This project proved to be one of the most challenging due to the aggressive timeline, complexity, and requirements. 

First, the client required to print and inspect cartons both Serialized and Non-Serialized for the US and Canada product lines using Thermal Inkjet technology.  Another requirement, which increased the difficulty level, was UV printing and inspection. In addition, QR codes were required for their China products which included Chinese characters. 

For the equipment side, the system had to be compact enough in order to be integrated into the existing space available, but it had to be able to process the product dependably at a high production rate.  The machine had to have the ability to handle different sizes and materials of the cartons being processed. Also, print and inspect and aggregation for Bundles and Cases was required as well as Palletizing and Rework functions (locally and remotely). 

Besides the equipment, integration of the new systems with the existing equipment was another requirement of the client.  Next in order of execution was the Validation support. The customer had limited knowledge with the new serialization solution and equipment.

Finally, training was required for Operators, IT, and Validation department, both theoretical and hands-on in order for them to complete validation and ultimately use their new equipment in their regular production environment.

Solution:

For the Carton and Bundles, Ultimate Solutions brand protection division (UPAK Global) provided two U-Track FCG2-TIJ machines integrating print, inspection, and reject stations in a compact module which were easily incorporated in the existing client facilities with minor modifications made.

Our Automation experts developed internal logic to integrate existing cartoners, bundlers, wrappers, and case packer machines to ensure smooth operation between systems; avoiding jams and unnecessary downtime or stoppages.  Additionally, instead of bringing the existing Case Packer to our facility, our team of experts developed a “dummy box” which simulated the signals between our solution and the Case Packer. By doing this, we were able to start working immediately while simplifying the project logistics and reducing the total cost of the project for the client.

We provided Systech documentation, as well as guidance (from our Validation Department’s vast experience in Systech serialization systems validation) to their team in the development of their internal documents according to their SOP’s to ensure documents were ready on time, and the execution was done properly.

One of the biggest benefits provided to the client was Ultimate’s Systech Training Center, which brings the customers certified and experienced personnel along with in-house developed training lines.  With this, the customer was able to get to use the system beforehand, get to know how the system works and which features and requirements were needed for their specific project.

For us to complete this challenging project, a work plan as aggressive as the challenge presented had to be developed.  A team of experts in each area was provided as well as the flexibility to work different shifts to make sure every aspect of the project was attended with our characteristic attention to details.  Also, our Facilities for Integration and Testing (FITS), which include around 3,000 ft2 for testing, amongst other services such as conference rooms, electrical, and pneumatic utilities provided all the necessary space and tools for developing and testing in-house, reducing the downtime impact on the client production schedule.

Results:

In total, two U-Track FCG2-TIJ systems, one custom Pack-By-Layer station, two Rework Remote stations (laptops) and one QA station were provided and implemented.  Also, a handheld palletizer was included in the solution which completed the requirements of the customer.

In the end, we met all requirements within the established timeframe and were able to deliver a quality product while minimizing costs and downtime for the client.  It was, without doubt, one of the most ambitious projects we have had the privilege to work on. Being local to the client proved to be extremely convenient for us providing the service and for the client which didn’t hesitate to reach out to us whenever they needed.

“Enormous!  Being in Puerto Rico and near our facilities was great.  Our engineers and operators were able to obtain a hands-on experience while performing the Pre-FAT and FAT activities.  The Team was always accessible with open communication, in disposition, and responding our needs with solutions. They are trusted and reliable.”

-BI

Author: Roberto Castro, Field Engineer

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