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Fitting Track and Trace into a Patient-First Culture

Catalent’s Bloomington, IN facility meets U.S. and European regulatory deadlines via a turnkey approach on a vial and syringe packaging suite.

Catalent’s Bloomington facility serializes and aggregates vials and syringes.
Catalent’s Bloomington facility serializes and aggregates vials and syringes.

As the November/December print issue of Healthcare Packaging went to press, the life sciences community was right at the Nov. 27 Drug Supply Chain Security Act (DSCSA) enforcement deadline for manufacturers and repackagers to affix or imprint a product identifier to each package and homogenous case.

That same deadline faced Catalent Biologics, a drug development, delivery and supply partner whose mission is to get better biologic products to the patients who need them faster. The company’s “Patient First” culture involves providing development and manufacturing of pharmaceuticals, biologics, consumer health and beauty products from early development through clinical trials and on to commercial supply.

With track-and-trace deadlines looming both in the U.S. and in Europe, Catalent’s Bloomington team needed to add serialization and aggregation capabilities to an existing vial and syringe packaging suite at their facility.

“We were looking for a track-and-trace system that would satisfy customers’ of the Bloomington biopharmaceutical facility,” says Rebecca Book, Catalent’s Senior Process Engineer. “We started by talking to six different equipment suppliers and then accepted bids from three. Our top considerations were compliance, cost, turnkey implementation, ease of use and customer service.” Based on those criteria, Book notes, “Mettler-Toledo PCE had the highest score overall.”

Turnkey approach

“The biggest factor that tipped the scales was that Mettler-Toledo offered us a turnkey line,” adds Edward Krause, Catalent’s Principal Manufacturing Specialist. “We liked that they provided everything, from the equipment and software to integration and support. The similarities across all their solutions make it easy to train operators and troubleshoot.”

The new serialization-aggregation system was added to a line at Catalent Bloomington that produces a variety of biologic products in vials from 2 mL to 20 mL, and in prefilled syringes from 0.5 mL long to 5 mL standard, which are packaged in cartons. Added in 2017, the equipment represented the company’s first track-and-trace capabilities on an existing vial and syringe packaging suite.

Serialized data is printed directly onto the side of the cartons, and customers can choose to aggregate them into bundles and then cases or aggregate the cartons directly into cases. Cases are then aggregated to pallets for shipping.

“Historically, our facility has run mostly small batches because our customers are involved in clinical trials before they seek approval from the FDA. To maximize our production flexibility and minimize waste, we chose a mixture of manual and automated track-and-trace solutions,” says Krause. “However, we’re now handling more commercial products with larger batch sizes as our customers’ programs evolve and reach market. This equipment is able to scale with us as we further automate parts of the line.”