Chartwell incorporates Adents serialisation for DSCSA compliance

NY-based CMO selected Adents Seriza serialisation software for systems requiring flexibility and continued high throughput

Chartwell Pharmaceuticals, a contract manufacturer providing Rx solid dosage, packaging and analytical services, recently implemented software from Adents, provider of track-and-trace software solutions.

This choice was to assure compliance with current and future track and trace deadlines.

Selected for its flexibility, scalability and ease of deployment, Adents' Seriza software has been incorporated to serialise products from several bottling lines, all products at Chartwell’s Congers, New York (USA) facility.

Following the decision to purchase a new NJM bottle labelling machine, Chartwell sought a serialisation solution that would exactly meet the upcoming November Drug Supply Chain Security Act (DSCSA) requirements from the US Food and Drug Administration (FDA), while also being upgradeable for future mandates.

Chartwell’s system challenges

Chartwell’s line processed bottles with widely differing specifications, varying in size from 25-count to 2,000-count at speeds of up to 150 bottles per minute.

The new labeller, an NJM Trotter model TRW-126, was outfitted with a Cognex In-Sight series camera and integrated with a VideoJet thermal transfer printer.

The labeller's position at a multi-line convergence point was important. Chartwell wanted to avoid the need for a second or third labeller, which many serialisation vendors were proposing to prevent product backup.

The desired serialisation solution needed to be compatible with equipment from different manufacturers and also needed to handle widely varying products at a high rate of efficiency.

Ultimately, Adents Seriza software was chosen as much by process of elimination as it was for its impressive set of features. Simply put, Chartwell had demands that most track & trace solutions cannot meet.

Eric Farkas, Chartwell’s Head of Corporate Engineering, said: “We especially liked that Adents is totally equipment-agnostic, with a high level of interoperability for our existing hardware.”

Adents Supervisor and Adents Pilot

At the site level, Adents Seriza employs a centralised configuration and process software called Adents Supervisor, which enables interface with ERP and EPCIS systems, multi-line configuration and serialisation parameters management for country-specific requirements.

At the line level, process execution software called Adents Pilot connects to site-level software and operates with a variety of line equipment to provide unit serialization, multi-level aggregation and rework.

Fast implementation

Another important element for Chartwell was speed of implementation. To minimise impact to production schedules, Adents Seriza was incorporated into the labeller at NJM’s factory, where it underwent its Factory Acceptance Test (FAT).

This required Adents to be onsite at NJM for two weeks of integration and one week of support to ensure critical milestones were met.

The software was installed within five days, ready for execution of validation scripts. The agreement allowed up to 20 days, so the fast instalment saved Chartwell three weeks of downtime.

Multiple product labelling

Multiple product labelling and vision formats were implemented, spanning Chartwell’s entire customer base. New split formats and 90° label formats were added to the system in two hours, eliminating the previous requirement of rotating and aligning equipment to accommodate those formats.

A significant reduction in setup time and lot changeover was realised by having the Adents software make such product adjustments, removing the burden from line operators.

“Adents Seriza enabled Chartwell Pharmaceuticals to process more than a million units in just the first month of production,” said Christophe Devins, CEO of Adents. “This quickly developed total trust in our software’s ability to satisfy current deadlines and future pharmaceutical regulatory mandates in the years ahead.”

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