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Pharmaceutical package-level temp monitoring

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

How does package-level temperature monitoring reduce risk against customers’ claims and provide a business management tool for improving operations?

Unlike foods, where temperature abuse is visibly evident, pharmaceutical products rarely show signs of temperature excursions. Package-level temperature monitoring may be beneficial for some specialty drug products that carry a high value and high risk to the customer if it’s potency is reduced. The monitoring may be more critical in business units that have less control of the transportation process and conditions, such as mail order pharmacies.
Dr Jean-Pierre Emond, Director Cold Chain Research, Georgia Tech

 

Too many operators see legislative or customer-driven standards in the cold chain solely as a cost that has to be met rather than an opportunity to enhance service. The cost of installing the hardware and software to meet base standards can rarely be recovered and meeting minimal standards offers little benefit to marketing the business. More imaginative application of the same hardware and software means carriers can market added-value services that potentially provide better margins.
Dean Stiles, Editor, Global Cold Chain News

 

Package-level monitoring can help reduce risk in two very significant ways.   First, today’s technology provides active monitoring of shipments in transit.  This allows immediate actions to be taken and contingencies triggered to prevent excursions in “live” shipments before they occur.  Secondly, from a perspective of initiating permanent solutions, package-level monitoring provides a true data record that, over many shipments, can be used to analyze non-compliant routes and initiate permanent corrective actions.
Bob Koplowitz, Global Director of Vertical Industries, Expeditors

 

Customer claims result from both real and perceived temperature excursions.  Temperature monitoring, at the package level, provides 100% data driven decisions about product condition upon receipt.  This data based confirmation eliminates false claims and, when qualified packaging is used, reduces the high costs associated with handling false claims.  With qualified distribution systems in place, any temperature excursions can be traced and will provide ongoing insight into process failures.  This insight allows for constant visibility and correction which increases patient safety and improves operational efficiency.
Jamie Chasteen, Product Development Manager,Cold Chain Technologies

Of all the potential risk factors that can exist within any supply chain, actually knowing that the drug that is being delivered within the package is compliant to its biological structure and protocol is by far one of the most important, if not the most important, specifically when it comes to cold chain. The bottom line for any company that wants to avoid potential law suits is to insure that quality and efficacy are maintained throughout the shipping processas this could be the one shot to save, or maintain a patient’s life.
Peter Norton, Senior Cold Chain Consultant, Intelleflex

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