CCUS3XE – 15-25°C, 72hr duration
“Upholding cold-chain integrity and regulatory compliance standards are morphing into major issues, experts say, with the explosion of temperature-sensitive pharmaceutical products, new global and regional manufacturing mandates, and supply chains extending worldwide. These are among the primary drivers affecting the development of specialized shipping boxes and containers used for transporting these drugs to market.”
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There are three fundamental means by which heat transfer occurs: conduction, convection and radiation.
All matter has a temperature associated with it. The way heat energy is absorbed, stored and released can have a profound affect on matter and can change its state of being. This is called phase change. Phases of matter or a substance are typically described as solid, liquid, gas and plasma. It is therefore important to recognize and understand the “types” of heat and their behaviors.
The dynamic performance of an insulated packaging system can be more fully understood when one understands the physics of heat transfer and the dynamic interaction of heat such as refrigerants (which act as a capacitor, like a battery), and insulated materials (which act as a resistor).
The acronym DQ/OQ/PQ stands for Design Qualification/Operational Qualification/Performance Qualification. It is a common industry best practice, and the basis by which an organization can reliably qualify temperature-controlled distribution processes.
What is an Ambient Temperature Profile?
An Ambient Temperature Profile is a statistical calculation, generally depicted in the form of a graph, which represents a series of uncontrolled prevailing temperatures over a fixed period of time within a specific environment or series of environments, such as a supply chain.
A stimuli article authored by Desmond Hunt, Ph.D., Senior Scientific Liaison at USP, and several members of the pharmaceutical industry has been initiated with the objective to solicit public comment and stimulate discussion regarding a potential revision—as yet unproposed in PF—of USP’s definition for Controlled Room Temperature. The proposal advances the view to expand the current definition of Controlled Room Temperature (CRT) from +20°C to +25°C to +2°C to +30°C. Continue reading