PMPN_Pharmaceutical & Medical Packaging News

Pharmaceutical & Medical Packaging News, September/October 2015

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27 September/October 2015 Pharmaceutical & Medical Packaging News • pmpnews.com devices that already require direct part marking (DPM) must be marked with the UDI on the device by September 2016. By September 2018, all Class I devices must carry UDI labeling and Class II devices that require DPM must carry UDI on the device. Finally, Class I devices that require DPM must carry a permanent UDI on the device by September 2020. Smart camera vision systems are a critical component of the UDI labeling process, not only to validate the pres- ence, accuracy, and readability of the various labels, but also to ensure prod- uct safety and package integrity. The UDI code is often read many times as the product moves from manufacturer to consumer. In time, all entries will be registered in a global database to docu- ment the chain of custody during the entire product cycle, making it possible to easily and quickly verify the authen- ticity of each pharmaceutical product. While some companies have consid- ered using their existing workforce to manually track and trace the pack- ages, there are concerns that human operators are vulnerable to fatigue, dis- tractions, and interruptions that may detract from their performance and make it impossible to provide 100% assurance of an accurate pedigree. Manual operations are inherently vul- nerable to untraceable errors, making it diffi cult or impossible to comply with UDI regulations. CODe ReADING ADVANCeMeNts Nearly all medical device manu- facturers and other device label- ers are using smart camera based Example of UDI Data Matrix with human-readable codes.

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