Developed by members of the ISTA Pharma Committee, this technical white paper discusses the use of reusable passive thermal packaging systems for temperature-controlled distribution of pharmaceutical and biological products.  The intent of this information is to establish an aligned industry best practice for the use of reusable packaging to transport temperature-sensitive medicinal products.  The level of detail beyond the suggested industry best practice is the decision of the primary stakeholders of the temperature-sensitive product, based on risk acceptance.  Thus, the examples given are for demonstration purposes only and may be more or less detailed than what is discussed in this paper.
 
This white paper provides specific guidance on the types of materials used in passive thermal packaging systems, the qualification of a reusable system, the return logistics and refurbishment service management, and refurbishment and inspection details