Intelleflex Point of View – Pharmaceuticals

Intelleflex asks industry experts their point of view on cold chain issues

Now that studies have shown RFID is safe for use with biologics, how will this impact the cold chain?

Dr. Jean-Pierre Emond, Director Cold Chain Research, Georgia Tech
The use of RFID in cold chain monitoring brings significant benefits for the pharmaceutical industry. First, you do not need to open a container in order to read the temperature inside which eliminates the potential of exposing products to the environment while keeping the integrity of the container. Second, monitoring the temperature of each shipment at any location in your distribution system may bring important information about potential “unknown” breaks in the cold chain that weren’t previously identified. The third benefit allows for corrective actions to be made during transit rather than be confronted with the problem at reception.

 

Greg Cathcart, CEO, Excellis Health
Biologics products are expected to drive 60% of the revenue for Big Pharma in 2012 and beyond. This switch in products, their cost and cold chain handling challenges will force the manufacturers to develop new Supply Chain strategies. At Excellis Health, we believe companies will need to evaluate and deploy technologies to track and trace these products through their supply chain. RFID tracking technologies are industrial strength and ready to support this mission. The benefits to manufacturers will be product visibility, integrity and quality.

 

Scott Pugh, Director of Strategic Business Development, Verify Brand, LLC
The recent findings means biologic serialization and traceability initiatives can confidently evaluate the use of RFID at any packaging level.   Companies in this position should ensure that all layers of their traceability solution, including data management, reporting, and authentication, are designed to unlock the full value of the richer and more real-time data which RFID and other sensor monitoring technologies can provide.

 

Larry Sweeney, Chief Operating Officer, DDN Dohmen
I anticipate companies will study their supply chains and gather sufficient data so that they can answer regulatory questions on safety and efficacy. At the same time the FDA has promoted RFID as a means of securing the supply chain, they also expect companies to have data that shows the product is unaffected by exposure. So while I expect adoption of the technology, I also expect it initially to be measured.  The primary reason for adopting this technology is patient safety.

 

Peter Norton, Senior Cold Chain Consultant, Intelleflex
Pending ePedigree laws in California 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. Because the study confirms RFID’s inherent safety, it will enable 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.

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