Fully Serialized and Aggregated Solution in Production for US Market

YARDLEY, Pa. - Leading pharmaceutical services provider PCI utilizes turnkey Xyntek and Antares solution and services to serialize and aggregate pharmaceutical products in preparation for meeting upcoming US Drug Quality and Security Act (DQSA) requirements.

The Xyntek and Antares team, working in collaboration with PCI, integrated Track-and-Trace technologies in support of PCI's global enterprise Serialization initiative across several US and European sites. These technologies include both line integration into highly automated equipment configurations as well as independent "flex line" modular Serialization configurations, enabling PCI to offer Serialization as a stand-alone service for clients looking to meet DQSA requirements. Xyntek-Antares provide PCI an end-to-end technology solution for Serialization, including both application and verification at the unit carton level, as well as aggregating to downstream processes including Serialization stages of tertiary packaging, loading of shipping cases, and palletization.

The Xyntek-Antares solution features the Print Check Advanced Module (PC Module) for unit carton serialization, applying 2D datamatrix and human readable information (lot number, expiration date, serial number) directly onto cartons as well as duplicate 2D Datamatrix to enable and support downstream aggregation processes. Two integrated vision cameras perform the vision inspections for both areas of print, respectively, and an integrated reject station handles incorrect/bad reads of the printed serialization information. Xyntek-Antares solution technologies support application, inspection, and aggregation of Serialized codes at each stage of the subsequent packaging operations up to the End of Line Manual Station for Serialization and Aggregation to pallets.

The turnkey Xyntek-Antares solution and technology is managed by specific software modules including:

Global Tracking System (GTS): Site server that is responsible for managing production recipe information, serial number management and allocation, and reporting for the entire serialization process.

Interface Tracking System (ITS): Interface software that integrates the data flow between the serialization solution and PCI's ERP system.

Master Tracking System (MTS): Line management software for serialized packaging line set-up, control, management, and operator interface.

Warehouse Tracking System (WTS): Software that handles post lot rework and decommissioning processes after a work order has also been closed.

Ian Parsonage, PCI Director of Global Serialization, explains, "Having several years of practical experience in commercial Serialization had PCI well positioned to evaluate potential partners for our enterprise Serialization strategy. In that evaluation process Xyntek and Antares really stood out for their demonstrated history of success, operational flexibility for equipment integration, ease of use for our staff, as well as the ability to easily configure software to the various needs of our clients for inbound and outbound data exchange. Implementing the Xyntek-Antares technology across our global site network gives us the confidence that we have a best-in-class solution and meets our requirements for providing the industry's leading customer experience. As we support clients in meeting both current Track Trace requirements for emerging markets as well as the domestic DQSA requirements, we feel Antares and Xyntek provide us a great platform for success."

Mac Hashemian, P.E., Xyntek CEO, explains, "The solutions implemented at PCI showcase the various options available for preparing packaging lines to meet serialization requirements. The Xyntek-Antares solution features pre-engineered modules and individual components that are skillfully and artistically integrated to the existing lines, thus providing our clients' a true turnkey offering."

About Xyntek and Antares

Xyntek and Antares offers a suite of Serialization, Track & Trace, and e-Pedigree hardware and software modules, turnkey full systems integration, GMP Validation, and Project Management services to help Life Sciences manufacturing companies define and execute on a serialization strategy that covers the factory floor and packaging lines through the entire enterprise and Supply Chain. With over 500 serialization implementations worldwide, and over 250 with full aggregation, from the unit through case through the pallet, the Xyntek and Antares solution is the most turnkey and proven solution in the world.

About PCI (Packaging Coordinators Inc.)

The global healthcare industry trusts PCI for the drug development solutions that increase their products' speed to market and opportunities for commercial success. Only PCI brings the proven experience that comes with more than 50 successful product launches a year and over four decades in the healthcare business. Leading technology and continued investment enables us to address global development needs throughout the product life cycle — from Phase I clinical trials through commercialization and ongoing supply. Our clients view us as an extension of their business and a collaborative partner, with the shared goal of improving patients' lives.

Press Release Contact:

Renee Cacciabaduo

Xyntek Inc.

(215) 493-7091 x225



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