To comply with serialization regulations, Catalent’s Bloomington, Indiana, USA team turned to Mettler-Toledo PCE for track-and-trace solutions that could be added to its vial and syringe packaging suites.
“When we started researching serialization and aggregation solutions, our top considerations were compliance, cost, turnkey implementation, ease of use and customer service. We spoke with six different equipment suppliers, and Mettler-Toledo impressed us the most,” said Rebecca Book, senior process engineer at Catalent Biologics.
“One of the biggest reasons we went with Mettler-Toledo PCE is they offer turnkey lines – they provide everything, from the equipment and software to integration and support,” said Edward Krause, principal manufacturing specialist at Catalent Biologics. “Since all our track-and-trace solutions come from one supplier and have similar user interfaces, it’s easy to train operators and troubleshoot.”
The PCE-equipped line at Catalent Bloomington produces biologic products in vials from 2 mL to 20 mL and pre-filled syringes from 0.5 mL long to 5 mL standard. The vials and syringes are packed into cartons, and serialized data is printed directly onto the side of each carton, as a saleable unit. Depending on the customer, cartons can be aggregated directly into cases or first into bundles and then cases. Finally, all cases are aggregated into pallets for shipping.
“Our customers’ products are beginning to go to market, so we’re handling larger batch sizes than we would for clinical trials,” said Krause. “We chose a mixture of manual and automated track-and-trace systems to maximize our production flexibility and enable us to easily scale as we further automate parts of the line.”
To manage all their track-and-trace data, Catalent Bloomington installed PCE’s Site Manager Level 3 software, a central repository for serial numbers and other product, order and line information. The software interfaces with TraceLink, a multi-tenant cloud solution, for two-way communication between Catalent Bloomington and their customers. The Site Manager is connected to the vial and syringe packaging suites via PCE’s Line Manager Level 1-2 software, which sends order information to intelligent devices, including cameras, scanners and printers.
In terms of equipment, the first track-and-trace step at Catalent Bloomington happens immediately after vials and syringes are packed into cartons. Here, the fully-automated PCE T2620 datamatrix station marks serialization information directly on each carton with an inkjet printer, and a PCE smart camera inspects the carton to confirm the data is correct. If there are any errors, a PCE pneumatic reject device removes the carton from the line, while approved cartons continue on to the next step. “This system is great. It’s user-friendly and has fantastic accuracy, like all of our equipment from Mettler-Toledo,” said Abbi Coleman, Equipment Lead at Catalent Biologics.
Next, a PCE T2660 Manual Aggregation Station aggregates cartons to bundles, when needed. The operator scans the 2D codes on the cartons to create parent-child relationships and record the serial information. A printer generates a serialized bundle label, and after the cartons are bundled, the label is manually applied.
To aggregate cartons and bundles to cases, Catalent Bloomington selected the multiple-code-reading PCE T2650 Shipping Case Station for maximum production efficiency. Instead of manually scanning each carton or bundle, an entire layer is manually packed into the case, and a PCE high resolution camera scans the 2D codes on all the cartons or bundles in the layer at once. After the case is filled and all the parent-child relationships are created, the printer generates a serialized case label.
Cases then move to a second T2660 Manual Aggregation Station, where they are aggregated to pallets for shipping. A third T2660 Manual Aggregation Station, found offline, handles rework. “These incredibly versatile systems can handle our customers’ many products and package formats,” said Book. “We could actually aggregate at every step using a single Manual Aggregation Station, but we chose to purchase three to increase our throughput.”
Just upstream of their PCE track-and-trace solutions, Catalent Bloomington relies on a XS3 checkweigher with a pneumatic push arm reject device, both from Mettler-Toledo Hi-Speed. By detecting any over- and under-filled cartons, it automatically removes any packages that may have missing or extra products or inserts. Approved cartons are conveyed on to the datamatrix station for serialization.
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