Scientific Standards For Ambient Temperature Profile Development

By Kenneth Maltas, Vice President of Engineering Auston Matta,  Engineering Team Lead R&D Kevin O’Donnell,  Technical Director D’Arcy Ryan

Storing and shipping highly temperature-sensitive drug products requires sophisticated packaging to ensure that the product remains safe and viable — from the manufacturing plant to the end user. Incorporating the appropriate ambient temperature profile into the design of this packaging is critical to maintaining the temperature control that these products require.

ThermoSafe Brands has developed two unique and comprehensive distribution temperature profiles for use in the design and development of temperature assurance packaging, as well as a proprietary analytical method for comparing ambient temperature profiles. The ISCgold™ and ISCsilver™ Ambient Temperature Profiles allow users to choose a design profile based on their specific shipping needs and criteria.

• The ISCgold™ Ambient Temperature Profile has been developed to meet some of the most extreme temperature conditions known to exist in the transport and distribution of drug products.
• The ISCsilver™ Ambient Temperature Profile has been developed to provide protection to packages under moderate or temperature-controlled distribution conditions.