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Pharmaceutical Manufacturing and Packing Sourcer

The Degrees of Variation

Jeff Leshuk at Sensitech instructs us in understanding temperature variation in order to achieve better cold chain management

Most companies dealing with temperature-sensitive medicinal products know that controlling temperature during handling, storage and distribution is critical. However, it is less widely known that temperature can vary significantly throughout the cold chain. Many factors influence the temperature of medicinal products throughout the supply chain and the dynamic nature of these factors increases the complexity of overall cold chain management. Where temperature requirements are crucial to the quality and safety of the product, and tolerances are relatively narrow, it is critical to obtain and maintain control. Understanding temperature variation is important in managing all types of processes, including the temperature-controlled distribution of medicinal products.

UNDERSTANDING TEMPERATURE VARIATIONS AND THEIR CAUSES

There are three primary types of temperature variation that may occur within a temperature-sensitive supply chain. It is important to note that all three of these types of variation may affect the product concurrently – and one factor or root cause may be responsible for more than one type of variation. However, for the purpose of understanding the causes of temperature variation, developing monitoring protocols and rational strategies to minimise variation are useful tools in the separate examinations of each of the three types of temperature variation.


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Jeff Leshuk has been General Manager of Professional Services for Boston-based Sensitech Inc since 1999. Jeff’s experience includes over 20 years in the food industry – in R&D, marketing and general management. His areas of expertise include post-harvest horticulture, cold chain management, modified and controlled atmospheres, and process improvement.
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Jeff Leshuk
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