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Item-level ePedigree

An item-level serialized RFID solution with “parent-child” association software is rolling out with five pharmaceutical applications including Pfizer’s Viagra.
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FILED IN:  Controls  > Strategy
     

It is based on Total Integrated Packaging Solution (TIPS) which was announced in November by Systech Intl. Tagsys and SupplyScape. TIPS is claimed as the first integrated solution to fight drug counterfeiting and increase patient safety.

Tagsys provides the RFID inlays that are converted into smart labels. A printer-encoder-applicator affixes the bottles with a pressure-sensitive RFID smart label printed with the bar-coded data.

TIPS Serialized Product Tracking manages all packaging line devices encoding and recording Electronic Product Code (EPC) serial numbers to high-frequency (HF) RFID tags and reading the packages’ bar codes. The software verifies all the data on the RFID tag and bar code to establish a parent-child association for the item-level units when they are subsequently multipacked in a case and then palletized. The software contains production order identities for units cases and pallets and records of all scrapped packages.

From Systech’s line management software the data is exported to SupplyScape’s programming which works with higher-level information management such as Enterprise Resource Planning.

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TIPS supplies track-and-trace serialization at multiple levels of unit case and pallet and it meets FDA 21 CFR Part 11 compliance. TIPS has been embraced by drug companies through five rollouts three in the United States. Most are implemented at the unit level for bottles but we are told one application is for a wallet-style blister pack.

Two of the programs are in Europe including one at Pfizer’s plant in France for its Viagra which is popular and often counterfeited. Pfizer plans to use RFID to authenticate all Viagra sold in the United States.

Here’s what we’ve learned about the RFID application for Viagra:

• The RFID project began last June. Product was RFID-enabled starting in October though the “go live” date was mid-November 2005.

• The Tagsys unit-level RFID inlays are a stock 5¼8”x1” flexible form factor that carry 512 bits of memory (384 bits of user memory) and are affixed to the backside of Viagra’s regular labels. The 2”x3” pressure-sensitive smart labels are wrapped around individual 30- or 100-count bottles.

• Unit-level laser coding provides an EPCglobal logo RFID warning and Data Matrix bar code.

• The unit-level tags are HF 13.56 MHz; case and pallet tags are UHF 915 MHz.

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