What is Climatic Conditioning Testing?

Climatic conditioning, also known as climatic testing, involves exposing a package or product to different controlled levels of temperature and humidity inside a calibrated test chamber. This simulates a range of climatic changes that may occur during distribution.

Different environments create different changes in the physical properties of a product or packaging. Through a variety of tests including humidity and thermal testing, STERIS engineers can simulate varying extremes of hot, cold, dry, and humid environments that cause degradation in the product or package.

These conditions can expose flaws in packaging, such as seals and glue joints becoming impaired and packaging getting damaged, impairing the package’s ability to protect the product. Tests are accredited to all the relevant standards for environmental testing including ASTM D4332, ISTA conditioning, IEC standards, and ISO 4180.

ISTA recommended conditioning profiles

Anticipated Conditions Time in Hours Temperature in °C ±2°C (°F±4°F) Humidity in %
Frozen or winter ambient 72 -29°C                       (-20°F) Uncontrolled RH
Refrigerated package 72    5°C                        (40°F) 85% RH ±5%
Controlled temperature 72  23°C                        (72°F) 50% RH ±5%
Tropical (wet) climate 72  38°C                       (100°F) 50% RH ±5%
Tropical (Wet)
then desert (Dry):
then 6
 38°C                       (100°F)
then 60°C               (140°F)
85% RH ±5%
then 30% RH ±5%
Desert or summer ambient 72  50°C                       (120°F) Uncontrolled RH
User Defined High Limit 72
Based upon known conditions
Known conditions


Guidance Documents/Standards:

ISO 11607 – Packaging for Terminally Sterilized Medical Devices

ASTM D4332 – Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

ISO 4180 – Packaging – Complete, Filled Transport Packages – General Rules for the Compilation of Performance Test Schedule

Contact our team of experts to find out more about our Global Contract Sterilization Services