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It's controlled room temperature time

Regulators and internal quality personnel are looking more closely at maintaining temperature-sensitive drugs in the 15° C to 25º C range.

With the number of temperature-sensitive drugs set to rise over the next few years, controlled room temperature (CRT) is becoming an important temperature range. Thermal deviations outside of the CRT envelope can comprise efficacy and patient safety.

As a result, regulators around the globe are paying closer attention to temperature controls and data results from shipments of CRT and “ambient” products. This attention has changed the industry discussion from cold chain management to temperature-controlled management for all ranges of product temperature sensitivity.

Although the majority of respondents of the 11th Annual Cool Chain Logistics Europe 2012 survey (83%), distributed products between 2º C and 8º C, the second most popular temperature range that respondents shipped their products in was 15° C to 25º C, at 39%.

Gary Hutchinson, cold chain expert in thermal packaging engineering and controlled environment logistics for biotechnology and high risk product and president at Modality Solutions predicted that the CRT supply chain landscape was set to grow.

“I think that’s going to be a huge market. I don’t think the volume is necessarily increasing, but the stance that the regulators are taking and even internal quality people at each individual pharmaceutical company are really starting to ask some questions about controlled room temperature and how do we maintain that temperature and show those controls in our distribution channels as well,” he says.

Collecting ambient data can be a time-consuming and expensive project. There are a number of challenges associated with determining temperature profiles for (15° C to 25º C) and (15° C to 30º C) regimes, distributing to countries with variable climates and redesigning packaging and labels that are mainly for use at chill and frozen temperatures.

However, these challenges also present opportunities for temperature-controlled supply chain service and solution providers looking to expand their offerings and customer base.

--Article provided by Cold Chain IQ, an international resource center for temperature control life science professionals.

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