What are the risks of "micro temperature excursions" in the cold chain?
The temperature log is normal, yet there are reasons for quality degradation. An explanation of risk management and measures to protect the quality of pharmaceuticals and bioproducts.
Although we should be adhering to the guidelines for refrigerated storage, the effectiveness of the products is somehow declining. The cause may be temperature changes that occur for just a few minutes, which get buried in the "average" of traditional monitoring systems. "Cold chain failure," which is the number one reason for vaccine disposal in many countries. This document thoroughly explains the nature of the "subtle deviations" that raise concerns about the quality of delicate biopharmaceuticals such as mRNA vaccines and antibody preparations, as well as how to prevent them. This white paper will detail the following points: ■ Risks lurking in daily life: "Localized temperature variations" caused by open doors or loading methods ■ Blind spots in monitoring: Damage that occurs instantly but is captured by records taken at 15-30 minute intervals ■ Latest countermeasures: "Proactive quality management" through resolution capability of 0.01°C and pre-alarm systems
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