Chartwell Pharmaceuticals, a contract manufacturer providing Rx solid dosage, packaging, and analytical services, recently implemented software from Adents – provider of versatile and easily deployable serialisation and track-and-trace software solutions – to assure compliance with current and future track & trace deadlines.
Selected for its exceptional flexibility, high scalability, and ease of deployment, Adents Seriza software has been incorporated to serialise products from several bottling lines all serialised products at Chartwell's Congers, NY facility.
Following the decision to purchase a new NJM bottle labeling machine, Chartwell sought a serialization solution that could be implemented quickly, was hardware-agnostic, and would exactingly meet the upcoming November DSCSA requirements while being upgradeable for future mandates. For its search, Chartwell assembled a senior-level, cross-discipline team representing its production, engineering, quality assurance and validation departments.
A Tall Task for Trace & Trace
Chartwell's line processed bottles with widely differing specifications, varying in size from 25-count to 2000-count at speeds of up to 150 bottles per minute. The new labeler, 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. So not only did the desired serialisation solution need to be compatible with equipment from different manufacturers, it 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 can't meet.
"The flexibility, ease of use, and reasonable cost of Adents Seriza all factored into Chartwell's decision," said Eric Farkas, Chartwell's Head of Corporate Engineering. "We especially liked that Adents is totally equipment-agnostic, with a high level of interoperability for our existing hardware."
At the site level, Adents Seriza employs a centralized 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 serialisation, multi-level aggregation and rework.
Speedy Implementation Decreases Downtime
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.
Initially, Adents agreed to set up the software in less than 20 days. In actuality, the software was installed ahead of schedule, taking only five days to get the system ready for execution of validation scripts – thereby saving Chartwell three weeks of downtime.
Furthermore, 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 just 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 over 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 not only current deadlines, but future global pharmaceutical regulatory mandates coming in the years ahead."