Catalent Biologics Turns to Track & Trace to Keep Compliant
Case Study

Catalent Biologics Turns to Track & Trace to Keep Compliant

Case Study

METTLER TOLEDO PCE provides a Track & Trace solution for vial and syringe packaging

Catalent Biologics, a leading provider of advanced delivery technologies and development solutions for biologics, needed to implement serialization processes in their Bloomington, Indiana facility. After speaking with a variety of equipment suppliers, the team elected to go with METTLER TOLEDO as their partner for serialization. The main reason? METTLER TOLEDO offers a complete, turnkey solution – from hardware to software, and installation to support. This means everything related to the Track & Trace  process uses the same user interface, simplifying the training process for new operators.

The specific application of the Track & Trace line at Catalent's Bloomington facility is the serialization of cartons containing vials and pre-filled syringes. These cartons are meant to be individually saleable units, meaning they need to be individually serialized. After each carton is serialized, it is bundled together for aggregation. Depending on the customer, this either begins by aggregating cartons into a bundle, then a case, and then a pallet – or the step of bundle to case is skipped, and cartons are aggregated directly into a case. 

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"We chose a mixture of manual and automated Track & Trace systems to maximize our production flexibility and enable us to easily scale as we further automate parts of the line," explains Edward Krause, Principal Manufacturing Specialist. 

Managing all the data from the various serialization and aggregation processes was also a significant concern, one which found the PCE Site Manager and PCE Line Manager software suites up to the task. The Site Manager software handles all the level 3 interactions, serving as a repository for information relating to the serial number, product, order and line status. 

The first step of the serialization and aggregation process uses the T2620 Datamatrix Station, which marks each carton with serialization information and immediately verifies the data using a smart camera. Any cartons with printing errors are immediately rejected, while approved cartons continue downstream to the next step in the process – aggregating cartons to bundles. As this step is not always required, Catalent opted for a manual solution here – the T2660 Manual Aggregation Station. Each carton's 2D code is scanned by hand, and the system creates a parent-child relationship with a code which is assigned to the bundle, and a label with the aggregated code is printed for application to the bundle. 

Cases are similarly aggregated, although in this case the line uses a T2650 Shipping Case Station, which automatically scans all 2D codes in a case layer at once. Once the case is filled, another label is printed and applied to the case surface. Completed cases are further aggregated into pallets using another T2660, and, should it be necessary, a third T2660 off the production line facilitates any rework. 

The Track & Trace equipment is not the only METTLER TOLEDO equipment in the facility, however. Just upstream of the start of the serialization process, a METTLER TOLEDO XS3 checkweigher ensures that each carton is properly filled – detecting any overfilled or underfilled cartons and removing them before serialization. Along with the Track & Trace equipment, Catalent considers their equipment from METTLER TOLEDO to be an essential element to successfully fulfilling their commitments and making their customers happy.

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