ISO/TC 122/WG 16 - Temperature controlled product packaging

This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling. This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.

This document specifies the test methods of temperature-controlled packages for parcel shipping. Tests include physical, thermal conductivity and insulation performances of transport packages that use insulation for the purpose of blocking thermal conduction between the inside and the outside of a product package that need temperature control.

This document specifies the general requirements of transport packaging, especially the containers, which are formed or prepared for the temperature-controlled transport services of parcel shipping. Safety or sanitation is not covered in this document. This document set outs the general requirements for transport packaging for safe storage and distribution of temperature-sensitive products.