A New Study: RFID Safe for Biologics

A new study published in the July/August edition of the Parenteral Drug Association’s PDA Journal documents research that showed that in vitro test results for more than 100 biopharmaceutical products from eight major drug companies demonstrated no non-thermal effect by radio frequency radiation. The study is available to PDA members on the PDA website.

What does this mean?

The study, conducted by researchers at The University of South Florida, Blood Center of Wisconsin, Abbott, Georgia Institute of Technology and the Madison RFID Lab at the University of Wisconsin documents that using RFID in conjunction with biologics is safe. The thermal effects of RFID on biologics have been well understood (no impact) but there had, to this point, been limited research on the non-thermal effects (RF radiation) of RFID on product integrity. The research study provides very thorough documentation as to how the tests were conducted with the most commonly used RF bands (13.56 MHz, 433 MHz, 860-960 MHz and 2.4 GHz). UHF RFID (such as Intelleflex) uses 902-928 MHz in North America and 865-868 MHz in Europe, for example.

Why is this Important?

Pending ePedigree laws in California (going into effect in 2015 and ultimately impacting the entire industry) are likely to require a combination of RFID and 2D barcoding systems with RFID being suggested for use at the package or pallet level and 2D barcodes being used at the item level. But some had questioned whether or not RFID was safe to use for ePedigree track and trace solutions, when placed in close proximity to the products. The study demonstrates RFID’s inherent safety, enabling technology companies, pharmaceutical manufacturers, shippers, 3PLs and health care providers to move forward more aggressively on developing solutions for ePedigree and documenting the safe and authentic shipments of biopharmaceutical products.

This is important as there appears to be a real dilemma as to what to do in the way of readiness for the California ePedigree initiative and how to combine this with any future directives that maybe pending at other state levels or globally. ePedigree has been a cloud hanging over the pharmaceutical industry for some time now. And, with the recent announcements that there won’t likely be any new initiatives to introduce a national standard for drug tracking and identification as a measure towards anti-counterfeiting any time soon, there’s a new level of activity among the manufacturers, distributors, wholesalers and re-packagers, about what needs to be done to prepare for next steps.

The FDA set in place a recommendation of how individual drug related products should be identified using a Standardized Numerical Identifier (SNI). This SNI which contains both a human readable section and a place to include a GS1 form of 2D and 1D barcode indicating a unique serial number and item I/D code. However, this is only an FDA recommendation based upon industry input and not a regulation.

In simple form, companies that comply with the GS1 standards can acquire blocks of Global Trade IDs (GTIN’s) from GS1 which will be unique to that product. Companies that receive the products down the supply chain will then need to verify the identity of each drug at the item level when it is received and they will need to maintain the chain of custody while the drug is in their position and document it’s delivery to the next point in the chain. However, this alone does not define either an e-Pedigree format, or a true track and trace requirement.

Assuming no last minute changes to the ePedigree law from the California Board of Pharmacy, starting in January 2015, companies that ship pharmaceutical products to California, will need to have sorted this all out and define their procedures for adhering to the ePedigree law. It was expected that 2D barcodes would serve as the main data carrier, but California had implied that they anticipated that RFID would be used and left open the potential for further defined recommendations to see what other new technologies may present themselves once the laws were in force.

Undoubtedly, once clearly thought out in regards to positioning on the item level component, 2D barcode on the individual saleable items has always been the best alternative. But, in regards to the carton and pallet level, RFID presents itself as a better alternative in regards to readability, data storage and potentially other uses towards an e-Pedigree solution and true track and trace options.

RFID Also Provides Condition Monitoring Capabilities

Beyond track and trace and ePedigree, RFID can add even more value. Temperature sensor RFID tags, can also be used to monitor and manage the temperature (and the safety and efficacy) of drugs as they move through the supply chain to reduce waste and improve cold chain operations. The rapid increase in the number of biologics – and their high value – make monitoring and managing their condition as they move through the cold chain increasingly important.

Because intelligent sensor-based RFID tags can be read through packaging during transit, they enable the intelligent supply chain for biologics while also being a key component of the ePedigree solution.

These synergistic components combine to create an ePedigree solution to track serial numbers, waypoints that indicate chain of custody changes, and a permanent record in the data base for QA and regulatory audits.

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