YARDLEY, Pa. — A top 20 multi-national pharmaceutical research and manufacturer is utilizing the Xyntek-Antares solution and services to implement an expedited serialization packaging solution in order to meet product serialization requirements for the Chinese market.
The requirements established for serialization by the Chinese government differ from the standards used in the USA. While each pharmaceutical packaging line generally possesses a unique serialization solution, this project and its serialization solution were specifically designed to meet requirements set for the Chinese Market. The Chinese pharmaceutical serialization market is a unique regulatory commission which utilizes the government-controlled EDMC serialization codes. These codes must be requested by the manufacturer and reported back to the government regulatory body when the product is fully packed and serialized.
The solution implemented is a compact, mobile, and flexible solution which enables the client to serialize the product at the unit, carton, and case level. To meet the aggressive timelines and requirements for the project, Xyntek-Antares implemented the Antares Manual Station. The module manages both the commissioning and checking of the pre-printed serial numbers on cartons, as well as the production and verification of serialized labels for cases. The compact module is fitted with bundled software to achieve the client's requirements, including:
• Global Tracking System (GTS) software, for the management of production information, and management of data integration required for receiving and translating the serialization information obtained from the Chinese regulatory body.
• Master Tracking System (MTS) software for line control and manual case packing and serialization operations. Warehouse Tracking System (WTS) software to allow for rework and decommissioning processes after a work order has been closed and before the commissioning file is sent to the CFDA.
Mac Hashemian, P.E., Xyntek's CEO, explains, "The implementation of the Xyntek-Antares solution on the client's site for the Chinese Market has allowed our client to efficiently and reliably meet the CFDA requirements and track and trace product throughout the entire supply chain. Additionally, the Xyntek-Antares solution has not only met the necessary governmental regulations established by China, but has also ensured that only authentic and quality product will reach its consumers. The versatility of our serialization solutions involve an intricate and fully customizable handshake of hardware and software components, which allow the ATS system to be applicable to any client's packaging, regulatory, and serialization needs anywhere in the world. The Xyntek-Antares solution ultimately ensures the production and distribution of safe and reliable product through its robust and intuitive line level functionality."
The Xyntek-Antares solution 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 the Life Sciences manufacturing corporations define and execute a comprehensive serialization strategy which covers the entire factory floor and packaging lines all the way through the entire enterprise and Supply Chain. With over 400 serialization implementations worldwide, and over 250 with full aggregation, from the unit, through case packing, through palletizing, the Xyntek-Antares solution is the most proven and mature solution in the world.
Elliot O. Abreu