Not too long ago, “ambient,” “room temperature” and even “controlled room temperature” (CRT) were considered synonymous and, as they were considered more or less resilient again temperature excursions, were provided little to no thermal protection across the supply chain. However, this is beginning to change. Increased regulatory focus, an improved understanding of how inappropriate storage conditions impact product integrity and the increased volume of temperature sensitive CRT biosimilars/biologics have pushed manufacturers to pay just as much attention to room temperature products as they do traditional cold chain drugs.
This being said, transporting room temperature drugs is not without its challenges. Though it may sound counterintuitive, safeguarding room products from temperature excursions can actually be more expensive and difficult than protecting their cooler counterparts. From reasons raging from costs to simple effectiveness, one simply just can’t apply the same solutions and methodologies to ambient products as they do those that require refrigeration.
With this in mind, below we’ve outlined the key challenges and solutions associated with protecting CRT and ambient drugs across the supply chain.
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