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Are there any guidelines for determining the sensitivity of a package to environmental stress (temperature, humidity, time)?
Last Updated On November 9, 2010
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 Flexible Barrier Packaging recently developed a practice for climatic stressing of packaging systems intended for single parcel delivery. This practice provides guidance for selecting appropriate climatic stresses when structuring a package design qualification regimen. ISO 2233, Packaging – Complete, filled transport packages and unit loads – Conditioning for testing, provides guidance on conditions designed to mimic specific environments. Although not consensus standards, ISTA 2A, ISTA 3A, and ISTA 6 series also provide guidance on climatic stressing.
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.