Big Pharma Logistics: E-Pedigree, RFID and Cell-Phones

Contributor: Cristina Falcão
Posted:  10/23/2012  12:00:00 AM EDT
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Tags: Cristina Falcão | pharma logistics | logistics | RFID

Globally, commercial goods, pharmaceutical, biomedical/biologics including commercial and military aerospace industries all experience product infiltration with unknown, non-genuine, stylish imitation, countless after-market knock-offs. Within these mentioned applications, the basic method of applying an adhered seal is lacking and insufficient as the seal is quite easily substituted or replaced.

The U.S. Food and Drug Administration (FDA) in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act states that:

"A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them."

An e-Pedigree is simply an electronic document which satisfies a pedigree requirement. The primary purpose of an e-Pedigree is to protect consumers from contaminated medicine or counterfeit drugs.

The state of the art within pharma companies

Back in 2009, several pharma companies tried, unsuccessfully, certain brand protection methods, but there is no resultant electronic globally accepted standard in identifying e-Pedigree.

Pharma companies are charting diverse inadequate security formats maybe because the FDA Strategy, Standards People have not taken any real position - probably waiting for California's 2015 Regulations and Legislation to evolve.

An idea to ponder and consider is the use of cell-phones with pRFID readers compressed and integrated, not a cost at those volumes, and practicable for other applications that are already on their way.

Cell-Phone Carriers are the 'common-denominators' for the e-Pedigree Program; if we can use a cell phone attachment to read the chip embedded in a credit card, then so the same attachment can read the authentication chip [dice] embedded in a label/heat shrink cap/sealed box etc., of the merchandise. The Point of Sale purchase is routed thru' a 'Process Gateway' and the product verification thru' an 'Authentication Gateway'. Both can be just one and the POS is already moving into the marketplace for cell-phone purchases.

The cStar ‘C3’ solution

The cStar ‘C3’ solution will recognize and establish the most synchronized and operative mechanisms using an ‘Authentication Drug Gateway’ to immediately respond and vigilantly alert both manufacturers and end-users [general public], of the existence of counterfeits; the cell phone user will be immediately aware  of any risk when purchasing medicines from any sources. It can also make international alerts to wide area networks.

Primarily it assures that the original contents have not been tampered with and secondarily it provides extra actual brand protection because a two-way authentication and recording process between end customer and manufacture is linked via a networked pRFID Cell Phone WWAN in micro-seconds.

Pharma companies must start from point-of-manufacturing at an appropriate point prior to sealing/shipping the commodities, as a safe guard and to help with tracking the shipping container is monitored for correct stuffing by the throat box reader, which matches up and interrogates pharma shipping for accuracy and activity. The detached standalone frame above the shipping box is a bench mount detector, which monitors shipment against a consignment manifest; it all starts here.

The process in which these mentioned products are authenticated to be genuine begins with said manufactures of products registering an account with a central communication facility, database or system, referred from here on in as an Authentication Gateway, which would allow authentication traffic to be routed to the specific manufacturer. The manufacture packaging their respective products will strategically place an RFID tag containing a unique identification number associated with the manufacture with an encrypted data string to be used to confirm product history/genuineness. This can be done using a duplex two-way rolling-key authentication code and it will be processed between manufacture and Stealth pRFID tag via the Authentication Gateway.

The manufacture brand authentication process begins with launching the application on pRFID Reader enabled cell phones. Upon the start of the application, the customer will proceed to present the cell phone in front of the product.  If the package has not been tampered with, then the antenna and chip [dice] of the RFID tag will be intact, thus allowing the RFID reader to initiate the read of the pRFID tag.  The RFID tag will have an encrypted string containing information, which will direct the authentication process to the correct manufacture in order to obtain the rolling key for that day/date required to authenticate the product.

It is a match of the  “Vin Methodology”, designed for a single automobile, only now electronically super enhanced for a volume mass-merchandising market for high value biologics and also high value commercial/industrial commodities.

Here is the flow chart:

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(Courtesy of www.cstartech.com)




Contributor:   Cristina Falcão


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