Three common ASTM Environmental Package Testing specifications are:
- ASTM D6653, Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
- ASTM D4332, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
ASTM D6653 determines the effects of pressure differential or high altitude on packaged products. This could be when packages are being transported by aircraft or transported by ground over high mountain elevations. The typical test parameters for ASTM D6653 are:
- Number of Samples: 3
- Sample conditioning: 6 ± 2°C for a minimum of 24 hours
- Altitude Level: 16,000 feet (4,877 m) ±5%
- Duration under vacuum: 1 hour
- Temperature while under vacuum: 5.6 ± 2°C
The altitude test pressure may be modified based upon knowledge of a specific shipping environment. DES has extensive altitude testing capabilities in our ISO/IEC 17025 accredited lab from below sea level to space altitude testing.
ASTM D4332 is a procedure to simulate climatic field conditions that a package or container may encounter during its lifetime. It can also be used to pre-condition packages prior to performing other transportation simulation tests such as ASTM D4169. The test environments described in ASTM D4332 are either historically accepted or special conditions chosen to represent the distribution cycle of a package.
The reason for using ASTM D4332 is because many materials contained within packages undergo changes in physical properties as the temperature and humidity varies. Its intention is to create an environment that may be used to assess changes in physical properties of samples in a reproductible manner.
ASTM D4332 is performed by placing a package in an environmental chamber. The package is exposed to controlled temperature and in some cases humidity for at least 72 hours. After the test, DES will create a detailed test report that describes the test temperature, relative humidity, time of exposure, test samples, and observations.
DES provides testing services to ASTM F1980: Accelerated Aging of Sterile Barrier Systems and Medical Devices in their accredited lab. ASTM F1980 is used to assess the integrity of sterile barriers and physical packaging materials over time. Package handling, shipping, distribution, and extreme climate testing are beyond the scope of ASTM F1980 and would require additional package tests.
Why perform an accelerated aging or shelf-life testing? Materials and adhesives used in sterile barrier systems or medical products may degrade over time. Accelerated aging tests demonstrate that a sterile barrier system will not lose its integrity throughout its shelf life. Although real time aging is the best source of information, accelerated aging tests provide much faster results which helps to reduce product development schedules. It should be noted that ASTM F1980 recommends that real time aging studies are performed in parallel.
ASTM F1980 accelerated aging tests are based upon the Arrhenius reaction rate function. This function states that a 10°C increase in temperature results in a two-fold increase in the chemical reaction rate (Q10). Thus, Q10 is an aging factor for 10°C increase or decrease in temperature. It is important to also consider relative humidity during accelerated aging as moisture may affect some materials.
What is the accelerated aging process? Accelerated aging is performed in a chamber at elevated temperature sometimes with controlled humidity. By testing items at more extreme conditions than they will normally experience, you can evaluate how they will age under normal conditions in a reduced amount of time.
What are the steps involved?
- Selecting a temperature (TRT) that represents the Room or ambient storage conditions. Typically, between 20°C and 25°C.
- Determining the accelerated aging test temperature (TAA). Typically below 60°C. Temperatures higher than 60°C can cause nonlinear changes in materials.
- Determining the accelerated aging factor Q10. Typically Q10 is chosen to be 2, however it can range between 1.8 – 2.5.
- Calculating the Accelerated Aging Factor (AAF) using the formula:
- Computing the aging test time (AAT) duration by dividing the normal storage duration by the AAF.
- Defining whether controlled humidity should be part of the test
- Specifying the number of specimens/products to be tested
- Performing the test
- After the aging test is completed, the products are evaluated for degradation.
- DES will then provide a comprehensive test report that describes the test temperature, relative humidity, time of exposure, test samples, equipment used and observations.
So if you need help with ASTM F1980 Accelerated Aging Testing, please contact us because we are testing experts and our lab is accredited!