New Track-and-Trace Solution Debuts from Crest Solutions and Eisai Machinery U.S.A. Inc.

Crest Solutions (Cork, Ireland) and Eisai Machinery U.S.A. Inc. (Allendale, NJ) have joined forces to launch a new track-and-trace packaging system that supports compliance with multiple local and international regulatory requirements in the pharmaceutical industry. The PharmaMarker system is designed to integrate easily into pharmaceutical production and packaging lines to facilitate pharmaceutical coding and traceability. The system was highlighted at Interphex April 20-22.

The PharmaMarker system has been developed to meet current rules such as those from France, Turkey, and California as well as future rules expected to follow. It can code, verify, and track up to 450 pharmaceutical cartons per minute to ensure that they can be fully traced along any point in their production lifecycle. The system integrates easily into a production line either as a stand-alone product or as a component of an integrated packaging line. It marks cartons with a Data Matrix code and then verifies it. Cartons that pass the verification station have their code details commissioned on Crest Solutions Protrack traceability software’s database, which can be shared with regulatory or ERP environments, such as SAP.

For the last 12 years, Crest Solutions has been working with pharmaceutical manufacturers to address packaging management problems. “The experience that we have gained from our extensive customer deployments and our collaboration with Eisai Machinery enabled us to develop the right product for the market," explains Frank Madden, CEO with Crest Solutions, in a press release. "This system is capable of handling new track and trace regulations not only coming into place now but also those due in the future. The cost to the pharmaceutical industry and to patient safety is too great to be ignored; there is significant market potential for this product as companies need to comply with new regulations. We are very pleased with the interest shown already and expect to sign up a new customer shortly."

Eisai Machinery U.S.A. Inc. distributes pharmaceutical production systems and equipment; its best-known product is the Automatic Inspection Machine (AIM), a high-precision instrument that detects impurities in ampoules, vials, or cartridges. AIMs are currently used by pharmaceutical manufacturers in Asia, Europe, North America, and South America. There are more than 1000 AIM machines installed in more than 50 countries worldwide. The newest Eisai inspection system is a high-speed, automatic inspection machine for syringes, operating at 36,000 items/hour.

Michael de la Montaigne, President of Eisai Machinery U.S.A. Inc., stated in the release: “The PharmaMarker is an easy-to-integrate, easy-to-validate solution for tracking and tracing pharmaceutical products, thus enabling manufacturers to immediately comply with ongoing regulations whilst also improving patient safety, counteracting fraud and creating a more secure supply chain. We are dedicating our resources and expertise in Vision and machine building while working strategically with our partner Crest Solutions, utilising their intuitive software which has helped make this an industry leading solution.”

The PharmaMarker solution utilizes the high-resolution In-Sight vision system from Cognex and coding and printing technologies of the Domino G-Series thermal ink-jet printer. Kris Bierbaum, Manager Strategic Alliances, Cognex Corp., said in the release: “Crest Solutions is a key Partner System Integrator (PSI) in our long-term strategy to address the pharmaceutical industry. Eisai Machinery U.S.A.’s PharmaMarker uses our High Resolution In-Sight vision system, which is the preferred platform for pharmaceuticals applications, due to its compact form factor and ease-of-integration. In-Sight reliably reads, grades, and verifies printed data with unmatched and repeatable performance. Eisai, Crest, and Cognex joint collaboration of industry expertise makes the PharmaMarker the ideal solution for companies that want a reliable and adaptable solution to meet regulatory changes without reducing existing production line parameters”.

Craig Stobie, Global Healthcare Manager at Domino, added: “We were very pleased that Domino was selected to supply coding devices for this solution. The number of emerging regulatory schemes for the coding, marking and labeling of healthcare packaging is one of the most significant challenges facing the pharmaceutical sector. Integrating seamlessly with Domino’s technologies for the healthcare sector — amongst which are the G-Series thermal ink jet and D-Series laser coding ranges — PharmaMarker is a highly proficient solution that addresses both immediate and longer term market requirements.”

Once cartons are marked with Data Matrix codes using the noncontact thermal ink-jet or laser print head, they are conveyed past the Cognex vision system to verify label data. Verified cartons pass to the next point in the production line, while failed cartons are removed using its automatic reject system. The system employs Crest Solutions’ LineDirector software to manage all the peripherals on the line and Crest Solutions’ Protrack real-time traceability software is used to accurately record event data for complete compliance with track and trace regulations.

Crest Solutions and Eisai Machinery, U.S.A. Inc. are currently in discussions with several companies to roll out the product globally. The PharmaMarker is available for demonstration and trials at Eisai Machinery USA’s headquarters in Allendale, NJ.

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