Pharmaceutical Technology Europe - July 2010 - (Page 5)

You can’t control what you can’t measure Barcode quality is a hot topic for the pharma industry, primarily because of mass serialisation, which has been mandated by several health authorities including France and Turkey, based on Data Matrix barcode technology. Therefore, maintaining an acceptable level of barcode quality in pharmaceutical production processes will be an increasingly important task, and a legal requirement. The error-free readability of the code should be guaranteed throughout global supply chain. The barcode issuer is responsible for the barcode’s readability by all readers, including older and even worn out readers. Just using a normal handheld reader to check the readability of the code is not sufficient; specialised testing equipment and measuring procedures are required, and a full range of ISO/IEC standards have been created to define barcode quality levels (grades) and measuring systems (verifiers). Barcode quality is measured in grades that can be reported as numbers from 0 to 4, or as letters from A to F (Figure 1). Grade A(4) is the best value and grade F(0) is the worst, indicating that the code is not readable (“F” stands for Failure). Very often, a barcode may, at first glance, seem so perfect that even experts would consider it a high-grade code. However, the verifier may grade it F. Why? A macroscopic investigation shows the problem: the code is geometrically distorted, is not symmetrical and therefore does not fit into the reference grid. The lesson learned is straightforward: the human eye cannot replace a specialised measuring instrument. Most Data Matrix barcodes with variable data content are printed inline on automated packaging lines. In-line quality monitoring is highly beneficial, but an in-line system will not provide the same accuracy as a stand-alone verifier because of limitations, such as very short measuring times and illumination restrictions. Used together, however, the two systems complement one another; the in-line system allows screening mass production while the standalone verifier can be used as an in-process control instrument to validate rejected samples, as well as to service and maintain the packaging line. PTE Sergej Toedtli Vesdo Ltd Based on a contribution by Sergej Toedtli, CEO of Vesdo Ltd. To read the full version of this article, go to www.pharmtech.com/toedtli www.vesdo.com Figure 1: Barcode grading scale. A 4 3,5 B 3 2,5 C 2 1,5 D 1 0,5 F 0 1 CONTENTS 8 EDIBLE MICROTAGS 3 OVERCOMING OBSTACLES 9 X-RAY ANALYSIS 4 EU LEGISLATION 11 RAMAN SPECTROSCOPY 6 DATA MATRIX CODES 14 TOP TECHNOLOGIES http://www.pharmtech.com/toedtli http://www.vesdo.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - July 2010

Pharmaceutical Technology Europe - July 2010
Can Pharma Keep Pace with the Counterfeiters?
Obstacles to Implementing an Effective Anti-Counterfeit Strategy: Can They Be Overcome?
EU Anti-Counterfeiting Legislation on its Way
You Can't Control What You Can't Measure
Data Matrix Barcodes: Points to Consider
Authenticating Drugs with Edible Microtags
The Power of X-Ray Analysis
NIR Chemical Imaging Could Hold Key Data
How Raman Spectroscopy is Benefitting Developing and Developed Countries
Overt Versus Convert Technologies
Serialisation is Here to Stay
Eight Latest Technologies Showcased

Pharmaceutical Technology Europe - July 2010

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