Tracking and tracing pharmaceuticals

Fiber lasers offer an efficient, repeatable, cost-effective approach for on-the-fly marking of pharmaceutical products

Laureen J. Belleville

Security, traceability, and efficiency in healthcare currently are at the forefront of government regulations and industry concerns around the world. Some key issues include counterfeiting, product recalls, adverse event reporting, medication errors, and efficient logistics management. In March of this year the GS1 Global Healthcare User Group (a neutral, not-for-profit organization dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility in supply chains) approved a global traceability standard for healthcare (GTSH) that is intended to ensure maximum interoperability between traceability systems across the healthcare supply chain and across borders.

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Staying abreast of such standards is key for companies like FP Developments (Williamstown, NJ; www.fpdevelopments.com), which manufactures production lines for the pharmaceutical and healthcare industries. On lines for some pharmaceutical customers, the company has integrated fiber laser coders that are marking data matrix codes, lot codes, or fill numbers on the aluminum bands that go around the top of the vials. These bands typically are less than ¼-in tall and the mark height is approximately 1/8 in—leaving little room for coding error. The company reports that it experiences less than 0.5 percent false rejects on its production lines and can customize the codes to meet requirements of different customers or countries where the vials are being shipped.

The codes must be clear and accurate, as they are verified by a vision system on the production line. Additionally, handheld barcode scanners must be able to read the barcodes at some end user sites. FP Developments can integrate all the technologies together on a line to implement a track and trace system, if required by the customer.

Standards compliant systems

The GS1 GTSH includes identification of parties, items, and events; labeling, marking, and/or tagging of traceable items; the nature and type of data to be captured and collected; record keeping including archiving/data storage; and communication and sharing of information (information can be shown at the physical level of packaging labels and printed barcodes). All traceable items must carry the identification allocated to it and be labeled/marked/tagged at source. Traceability data includes information about who, where, when, what, and what happened.

To enable it’s customers to comply with such standards FP Developments designs and manufactures its own laser and verification systems. For one pharmaceutical customer it designed a system whose sole purpose is to transport vials and orient them through a 2D coding and verification process utilizing a fiber laser and a vision system. The system is capable of handling pharmaceutical glass vials at a rate of up to 300 vials per minute. The laser coding and verification system is designed for integration with a Videojet (Wood Dale, IL; www.videojet.com) 7310 fiber laser marking system and a Cognex (Natick, MA; www.cognex.com) Vision 5600 Insight inspection system. The system presents vials to the laser to mark the seal skirt surface. They then continue to be fed past the vision system where they are read and given a pass or questionable reading. All vials that are designated a pass grade are allowed to continue through the system. All questionable vials are sent to a questionable vial tray by the laser coding and verification system. The system design allows for mechanical integration with all downstream and upstream equipment.

The laser has the capability to mark vials while they are in motion with a machine-readable 2D data matrix. The 2D data matrix is 12 x 26, capable of 22 alphanumeric characters. The laser receives the 2D data matrix values directly from the Line Director PC.

The 7310 20W pulsed fiber lasers are compact, versatile, and low-maintenance marking systems. Features of this laser include software that enables the user to create marking messages with automatically updated content (such as date, time, shift), symbols, graphics, foreign language, fonts, and imported illustration or engineering files. The fiber laser source (Ytterbium pulsed fiber laser) is internally fan cooled, eliminating downtime and maintenance of water coolers or external chillers. The laser’s scripting interface enables direct integration into complex production lines.

FP Developments has been doing business with Videojet for more than a decade, initially integrating the company’s ink jet products into systems for printing on leaflets, cases, cartons, and labels. However, labeled products are not able to withstand required terminal sterilization processes, whereby finished products are exposed to a validated process to kill any living micro-organisms. Terminal sterilization can be accomplished with ethylene oxide gas, radiation (gamma and electron beam), steam, or dry heat. Additionally, the code quality available with the ink jet did not reasonably meet the quality requirements of industry.

“For really small dots,” says David Pfleger, president of FP Developments, “you need a laser. But 8 to 10 years ago the laser price was prohibitive and mark-on-the-fly technology was not good.” But technology improvements over the years—from ink jet to Nd:YAG to fiber laser—have enabled the newer systems to reach the six sigma level in terms of repeatability. In fact, the availability of the fiber laser delivers a significant improvement over Nd:YAG lasers in terms of a smaller, crisper, more readable code. Pfleger also notes other benefits of the fiber laser. “Integration is better. The fiber laser is smaller and lighter than the YAG so positioning is a less-expensive proposition.”

Indeed, although FP Developments had configured a similar system to the one outlined above using a YAG laser, the company was never able to sell one. Over the past year, it has sold five laser coding and verification systems to pharmaceutical companies: one fiber laser unit in the U.S. and four UV laser units in Europe.

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