RFID in an automated system

FlexLink AB

The emerging world of RFID is impacting manufacturing and providing an excellent solution to companies seeking to improve processing throughput, tracking capabilities, inventory control, and anti-counterfeiting measures.

A new technology relative to other identification and tracking systems, RFID is receiving much attention from a variety of industrial market segments. In the medical device manufacturing sector, companies are looking at new methods to enhance time to market by improving throughput within their facilities. They are investigating this solution to see if it can help to increase profits. As an additional benefit, the technology enables users to resolve other concerns utilizing the same system. Anti-counterfeiting and inventory tracking/control are also benefits companies can realize from implementing an RFID solution.

The biggest benefit for medical device manufacturers, however, is still achieved when used as part of an automated system. Dave Clark, president of FlexLink Systems, Inc., USA, explains that "the ability to automatically link a product to an order stream in real time for track and trace" is the biggest advantage of an RFID system for most manufacturers. He adds, "This also allows for automatic record keeping and no longer is there a reliance on manual scanning and data entry.

Automated SystemsRFID tags have a much highter read rate than bar codes and allows for a more automated flow." If you combine an RFID tagging system and the right software, you can automatically record tag movements, entries, and data collection.

FlexLink completed a system for manufacturing catheter type products, where the product automatically traveled in the correct route, secure operator "electronic signatures" were included, and a complete history of operator and manufacturing process maintained, and all as part of the material handling system -- it was not necessary to have a separate package.

The material handling and process capture are integrated. The customer was able to validate the line in half the time it normally required for a CFR Part 11, GMP Compliant Manufacturing line.

Mr Clark continues: "Our software and compliant systems have been fully validated and proven to exceed the CFR Part 11 requirements. If an FDA auditor is expecting to see systems where there is manual movement of products, manual data entry for track and trace, and instead finds a fully automated, controlled movement system, I believe the risk of regulatory non-compliance would be non-existent.

Our systems have fully validated two months faster than manually controlled production environments. In fact, we set up an entirely separate company, Compliant Logistics, which focuses on providing the hardware, software, and consultancy to help these companies achieve validation."

This article is an extract from Medical Design Technology, April, 2007.

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