When the EU GDP standards were established in 2013 expanding temperature-control compliance requirements to CRT products, the first reaction of many companies was to apply the same technology as refrigerated containers—insulated boxes with gel packs. However, not only is it more difficult to keep a product at room temperature (because of the mass of PCM material necessary) than a refrigerated product, (whose PCM can pack more cooling into a given mass), it can also bbe significantly more expensive. Considering that, at least according to some estimates , 90–93% of drugs in the market are CRT (10X the size of the cold chain market), if companies were to
We don’t have to tell you that effective temperature management is critical for ensuring the safety and effectiveness of all types of drugs, even those that may not classify as “cold chain” products such “ambient” or “room temperature” medicines.
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