Thermal Packaging Design Requirements

What thermal design requirements need to be defined for designing thermal cold chain packaging?

• Product Description

  • Size, make-up

  • Product is liquid or solid

  • Type of primary package such as a glass vial

  • Secondary packaging such as a chipboard box

  • Other physical characteristics

• Product Shipping Temperature Range - start with label claim, add stability data and develop excursions.

  • Typical Storage Temperature Label Claim

    • -20 degrees C and below (frozen)

    • 0 degrees C and below (frozen)

    • 2-8 degrees C (refrigerated)

    • 15-30 degrees C (room temperature)

    • 30 degrees C and up (elevated)

• Temperature Range Examples with Excursions

Typical Storage Temperature Label Claim	Typical Allowable Excursions to Temperature Range*
-20 degrees C and below (frozen)	Up to -10 degrees C
0 degrees C and below (frozen)	None
2-8 degrees C (refrigerated)	1-10 degrees C
15-30 degrees C (room temperature)	10-35 degrees C
30 degrees C and up (elevated)	None

* Note – allowable time durations for temp excursions should be based on product stability data. This data should be provided in the protocol

• Storage Conditions

  • Define Payload Storage Conditions

  • Define Storage Conditions of Refrigerants

  • Define Storage Conditions of All other Packaging Materials (Insulated Shippers, Bubble Wrap, etc.)

• Product Load Requirements

  • Define min and max payload sizes

  • Min/max bracket design

  • Variable Payload Area (Multiple Products)

• Method of Shipment and Duration

  • Where is it going?

  • For how long?