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Are there any guidelines for determining the sensitivity of a package to environmental stress (temperature, humidity, time)?

Last Updated On October 7, 2025

Ideally, climatic stressing protocols should be based upon actual field data from that product’s specific distribution, handling, and storage environments. In general, field studies have shown that packaging systems rarely reach the extremes of the outside environment. The large mass present in the shipping container or truck slows the heating and cooling process. In addition, in many distribution environments, the amount of time the packaging system is exposed to extreme conditions is relatively short, often less than 24 hours. If actual field data is unavailable, temperature and humidity choices should mimic those that the packaged product may see. Care should be taken to ensure that the temperature/humidity combination is based upon real-world conditions. For example, testing should not combine desert temperatures (55 – 60°C) with tropical humidity (85 – 90% RH) because that combination would not realistically be found on Earth.

ASTM Committee F02 on Primary Barrier Packaging recently developed a practice for climatic stressing of packaging systems intended for single parcel delivery (F2825) and for transit simulation testing (D4332). This practice provides guidance for selecting appropriate climatic stresses when structuring a package design qualification regimen.

F2825 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
1. Scope
1.1 This practice provides a uniform basis for evaluating, in a laboratory, the ability of a packaging system to withstand a range of climatic stresses that a packaging system may be exposed to during distribution throughout the world and still provide the product protection from damage or alteration.
1.2 This practice is designed as conditioning prior to testing for overnight or two-day delivery systems of a single parcel packaging system or as a standalone test for climatic stressing of packaging systems

D4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
1. Scope
1.1 This practice provides for standard and special conditioning and testing atmospheres that may be used to simulate particular field conditions that a container, package, or pack-aging component may encounter during its life or testing cycle. 1.2 This practice describes procedures for conditioning these containers, packages, or packaging components so that they approach or reach equilibrium with the atmosphere to which they may be exposed. This standard is commonly used for conditioning when conducting transit simulation tests.

There are further references available: ISO 2233, Packaging – Complete, filled transport packages and unit loads – Conditioning for testing, provides guidance on conditions designed to mimic specific environments and, although not consensus standards, ISTA 2A, ISTA 3A, and ISTA 6 series also provide guidance on climatic stressing. The method used to test packages after conditioning depends on the objective of the study. For guidance on the ASTM testing standards available for various purposes refer to ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products.

Climatic stressing should not be confused with accelerated aging. Accelerated aging protocols are intended to determine the effect, if any, of the passage of time on the integrity of the sterile barrier system and the physical properties of their component packaging materials. They are not intended to determine the effects of exposure to extreme climatic conditions. ASTM F1980 provides guidance for developing accelerated aging protocols.