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Noven upgrades its automated proofreading

Miami-based Noven Pharmaceuticals’ uses automated proofreading with Braille measurement and reading.

Noven Pharmaceutical's incoming inspection area is used to verifiy incoming materials for copy, Braille, and barcodes.
Noven Pharmaceutical's incoming inspection area is used to verifiy incoming materials for copy, Braille, and barcodes.

In the modern pharmaceutical landscape, organizations must navigate a global patchwork of regulations and standards in order get their product to market.

Noven Pharmaceuticals, Inc. out of Miami tackles this challenge every day.

A subsidiary of Hisamitsu in Tokyo, Japan, Noven manufactures and packages products to the American and European markets that includes prescription-only products, including those for women’s health (menopausal products), for attention deficit disorders, and for pain management. These products are sold to pharmacies, while other products are marketed and sold under a partnership.

European requirements for Braille and medication guides printed in all the European Union languages create quite the compliance challenge.

The difficulty is compounded by the need to deliver products in a timely fashion, while at the same time retaining a high degree of confidence in the accuracy of printed information on product leaflets, foils, cartons, and labels. In addition, Noven is reportedly one of the few companies doing business in the U.S. that ships products with Braille on the packaging.

Braille is printed on packages for products shipped only to European countries, where it is a regulatory requirement for doing business there. In order to ensure that visually impaired individuals can read the embossed Braille dots, Noven’s Quality Control Department must be sure the points are sufficiently defined and that the content is correct.

Technological solutions

Although digital proofreading technology has been around for decades, recent advancements have improved the capability of such systems beyond simple comparison of A to B, to encompass all the attributes of packaging and other printed components of pharmaceutical products. To meet the growing regulatory challenge of international business in the 21st century, Noven chose Complete Inspection Systems Inc, (CIS), to provide a new digital proofreading system.

The CIS equipment was installed, validated, and released for use in August 2013. The equipment installed included an AutoProof Pro with Image Compare software, Braille Verification System, and the Integra 9510 Barcode Verification System to both read and indicate that the barcode has been printed to ANSI standards. Only one system was installed—three components and two scanners, a wide-sheet scanner, and a flatbed scanner.

The CIS instrumentation replaced “a very old and obsolete camera-based system for text verification that was able to scan only small sections of the sample being inspected at a time. This was a very cumbersome and time-consuming task since some of our products are films,” says Ivette Larralde-Valdes, Senior QC Compliance Specialist at Noven. “During inspection, an approximately 1-foot by 2-foot film samples are cut to be inspected for text. The camera system only allowed a section of 4 inches by 4 inches to be inspected at a time. During an inspection, 30 frames or more had to be taken in order to complete a text verification inspection of a film.”

With the CIS equipment, only one scan (taken with a wide-sheet scanner) is made of the sample film and inspection is done with the image compare system. A master sample is also scanned, or used from the library, in the same manner and both images are compared at once. With one inspection, there’s one scanning, and quick results.

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INTRODUCING! The Latest Trends for Life Sciences at PACK EXPO Southeast