Industry Cracks Down on Temperature Variations

Controlled room temperature (CRT) shipping is poised to become the fastest-growing area of pharmaceutical shipping,Controlled room temperature (CRT) shipping is poised to become the fastest-growing area of pharmaceutical shipping, as drug developers and regulatory agencies throughout the world pay more attention to temperatures during shipping and storage.
Much of that attention is directly attributed to biologics that, analysts say, will have a compounded annual growth rate of 6.5 percent until 2015. That’s 1.5 percent higher than that of traditional pharmaceuticals. To accommodate these typically temperature-sensitive products, pharmaceutical companies are re-engineering their distribution systems.
In India in 2010, vaccines exposed to heat were linked to the deaths of 128 children. More recently, an October 2012 report from India’s Parliamentary Standing Committee on Health found that chocolate and soft drinks had priority over expensive, temperature-sensitive medications (including the cancer-fighter Herceptin) when it came to space in pharmacy refrigerators.
But temperature variations aren’t just an Indian problem. When Cold Chain IQ surveyed pharmaceutical executives, it found that at least 10 percent of respondents recorded temperature deviations in more than 15 percent of their temperature-sensitive shipments. Twenty percent didn’t know whether excursions had occurred.
Clearly, pharmaceutical manufacturers need a system that tracks product temperatures through the distribution chain. On that point, regulatory agencies worldwide agree. A few years ago they began issuing or amending Good Distribution Practices to include guidelines for documenting temperatures. The details vary by country, but the guidelines generally require verifiable, tamper-proof evidence that pharmaceutical products have been maintained at proper temperatures.
A robust monitoring system can meet those requirements. Simple go/no go indicators will meet many nation’s requirements. Data loggers may be required for others, providing detailed documentation of any temperature excursions, their duration and, where they occurred. For more information about strategies to protect your temperature-sensitive products, contact ShockWatch.

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