ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
The scope of ASTM F1980 covers the procedure for developing accelerated aging protocols to quickly identify effects of time on the sterile integrity of the sterile barrier system (SBS). The test will also examine the physical properties of the component packaging materials. The protocol is useful in determining and defending expiration dates. The test only addresses the passing of time on the sterility of an SBS, it cannot be used when evaluating factors such as environmental challenge, distribution, handling, or shipping. While this protocol is extremely useful and a good indicator of real-life effects of aging on an SBS, it is imperative that real-time aging studies are performed to confirm the results of ASTM F1980.
Often times, a sterile barrier system has an expiration date because sterility can no longer be guaranteed. Over time, the adhesive materials or cohesive bonds that maintain sterility begin to degrade and the package is compromised. Again, the accelerated aging process that is used to perform the test is still a simulation. There must be a real time test performed to verify the results. However, this test can be useful in order to get a product to market quickly if it has a long shelf life.
Before testing, it is important to understand some of the unique terms associated with this protocol. The most relevant terms include:
- Accelerated Aging (AA)- storage of samples at an elevated temperature in order to simulate real time aging in a reduced amount of time
- Accelerated Aging Factor (AAF)- estimated or calculated ratio of the time it takes the achieve the same level of physical change as it would in real time conditions
- Accelerated Aging Temperature- the elevated temperature at which the aging test is conducted, it can be determined by real life storage temperature, estimated usage temperature, or both
- Ambient Temperature- storage temperature for real time aging samples
- Sterile Barrier System Shelf Life- the amount of time that an SBS can be expected to stay in storage at the ambient temperature and maintain its sterility
To begin testing, the laboratory will obtain the appropriate number of samples of the Sterile Barrier Systems. The laboratory is equipped with a room (or cabinet) adequate in size so that the test specimen can be individually exposed to circulating air at the desired temperature and humidity. The room should also be equipped with a control apparatus, hygrometer, and thermometer. The samples are tested according to the theory that the chemical reactions that are involved in the deterioration of materials follow the Arrhenius reaction rate function. This reaction rate can be used to increase temperature and cut down aging time.
Once the test has been performed, the SBS will be evaluated for both physical properties and integrity. In some cases, package testing may be performed after aging to evaluate the performance of the aged packaging system during simulated distribution, handling, and storage. At the conclusion of testing, the laboratory will write a comprehensive report following the guidelines outlines in ASTM F1980.
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