Tagging Tools to Provide E-Pedigree - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Tagging Tools to Provide E-Pedigree
The pedigree requirement soon will take effect, and members of the pharmaceutical supply chain have little time left to comply.


Pharmaceutical Technology



The "FAST Tag" software exchanges information with the host system.
An RFID tag is just one of the security features that can be built into vial packaging for parenteral products. A 13.56-MHz tag measuring 9 mm in diameter is incorporated into standard 13- or 20-mm polypropylene seals in a co-injection molding process. Then, tagged seals are inserted into formed aluminum shells and heat staked in place. Each assembled shell is read to verify tag viability before being packed for shipment. The RFID-enabled seals serve as a drop-in replacement for standard seals and can be configured to be read-only; write-once, read-many; or write-many–read-many (9-mm 13.56-MHz tag, TAGSYS; "West Spectra" vial-closure system, West Pharmaceutical Services).

Data capture and storage

Many tag makers also supply readers (smart label readers, Symbol Technologies, TAGSYS, Alien Technology).

Encoding tags and collecting data from tags typically is controlled by specially designed software. The system on the Viagra line, for example, encodes tags, records EPCs, manages rejects, links bar-code and RFID data, and stores information in a database ("TIPS Serialized Product Tracking" vision system and software, SYSTECH International, Cranbury, NJ).

Similar software identifies items to be tagged, sends data to the encoding equipment, triggers tag application, verifies tag readability and code accuracy, and transmits data about tagged items back to the host system. It's typically supplied as part of an optimized turnkey RFID solution that includes assistance with tag selection and placement as well as hardware selection and installation ("FAST Tag" software, Accu-Sort Systems, Inc., Telford, PA).

Collaboration

Establishing e-pedigree systems will require unprecedented collaboration between supply-chain partners because success depends on sharing the data captured at each point in a drug's trip from manufacturer to consumer.

Collaboration will necessitate agreements about who owns the data, where it resides, who has access, and how access occurs. Cooperation also requires some degree of interoperability between systems. In other words, each system must be able to send and receive pedigree data securely in a format it and its supply-chain partners can use.

Like all RFID implementations, embarking on an e-pedigree program using item-level tagging should spur companies to undertake a full needs analysis to define requirements and goals. This process should consider both current and future needs. Once this analysis is complete, pretesting in a laboratory setting helps optimize conditions for the pilot-project phase. Rollout should occur only after rigorous testing during the pilot and then proceed in a phased fashion.

A successful e-pedigree program will involve a considerable amount of effort and expense. Although compliance with pedigree requirements is mandatory, numerous benefits will result in enhanced patient safety, stronger consumer confidence, reduced exposure in recall situations, and, of course, a higher level of supply-chain security that simplifies product authentication, discourages diversion, and minimizes the chance of counterfeit product being dispensed.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
31%
Breakthrough designations
8%
Protecting the supply chain
42%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here