Adopting Serialization - Pharmaceutical Technology

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Adopting Serialization
Serialized product codes serve as the foundation of ePedigree records and product traceability.


Pharmaceutical Technology
Volume 34, Issue 8

Devices

Implementing serialization almost inevitably requires the installation or upgrading of hardware such as printers and vision systems, which must be able to accept, capture, and transmit serialized information. Several integrated marking-verification systems are available.

One system consists of an inkjet printer, a built-in vision system, mechanical transfer devices, and air-powered reject. Compatible with various printers and vision systems, the unit applies serialized data to cartons, verifies that the information is accurate and uploads code data to a database for ePedigree records (XMV Marking and Verification System, Mettler Toledo Hi-Speed, Ithaca, NY). A related system adds a checkweigher for additional quality assurance (CS2 MV System, Mettler Toledo Hi-Speed).

A laser or thermal inkjet printhead prints serialized codes and other information on cartons; verifies print presence, accuracy, and quality with an onboard vision system; and records code data in an internal database. An air knife blows unreadable cartons into a reject bin equipped with a sensor that confirms that the reject has been made. A quick-change mechanism adjusts to a wide range of carton sizes. Software manages individual or multiple vision sensors, coding devices, checkweighers, and other peripherals (Pharma-Marker 450 Track and Trace System Eisai Machinery USA, Allendale, NJ, with vision technology from Cognex and Line Director software from Crest Solutions, Cork, Ireland).

A thermal inkjet coder capable of operating at a speed of 250 feet/min combines speed with sharp print quality to eliminate the need to slow the line to apply two-dimensional DataMatrix codes. A dual processor handles serialization data input and output in real time while integrated sensors confirm code readability. Communication interfaces include RS 232, USB-B, and TCP/IP (Wolke m600 Advanced inkjet, Videojet Technologies, Wood Dale, IL).


Software equips Cognex's In-Sight Vision Systems to perform tasks related to serialization and data capture.
A serialization system capable of 360 inspection relies on six cameras to provide high-resolution images. Positioned at the infeed of bundling, case packing, or palletizing, the system reads DataMatrix codes regardless of orientation, captures serialization data from each product, and generates coded labels. Integral software aggregates serialization data from units, bundles, cases, and pallets and transmits them to an enterprise resource planning system for storage in a database. The system also can encode and read RFID tags for cases and pallets (T&T Solutions, Seidenader Vision, Harrisburg, PA).

Preconfigured software equips camera-based vision systems for serialization tasks such as verification of code accuracy and print quality and capture and exchange of serialization data with other systems. An easy-to-use touch screen operator interface simplifies setup and operation. The software also includes technical controls needed for 21 CFR Part 11 validation, including secure user authentication and automatic audit-trail generation. Because the microprocessor-equipped smart camera performs processing functions, operators do not need a personal computer or related maintenance products such as virus protection software (In-Sight Track & Trace software, Cognex).

Line management

Line-management software plays a big role in serialization and ePedigree creation. Configurable software can expedite setup and simplify operation. Another time saver is software that is device- and data carrier-neutral and therefore works with virtually any printer, coder, scanner, or vision system and with various barcodes or RFID. Compatibility with other software, particularly high-level enterprise resource planning systems that may be in use, also streamlines implementation.

One method that incorporates all these features looks at any physical object on the packaging line as an item and each related action as a process block. Items move through a series of linked process blocks in a stream. A group of streams make up the workflow of a packaging line.


A software platform from Systech uses a building block approach to map the workflow of a packaging line.
This architecture makes the software easy to configure and expand without writing custom code, thereby expediting implementation and reducing costs. It also ensures repeatability, simplifies reconfiguration of workflows as needs change, and minimizes revalidation. "You don't need to be a software developer to install and configure our system," says Stephen Lisa, director of technical product marketing at Systech International. The software mirrors what happens in the real world, "there's not a lot of abstract C++ or ladder logic," he explains (Item Process Stream methodology for Serialized Product Tracking software, Systech).

A demonstration line helps drugmakers test the vision systems and software needed to support serialization. Compatible with either two-dimensional DataMatrix coding or RFID tags, the fully automated system includes all the inspection, line control, aggregation, and data management functions needed to successfully serialize product and capture data at each level of packaging from item to pallet (Capture and Control System, Optel Vision, Quebec City, Canada).


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