Some Common Shelf Life Tests
1 Year Shelf Life Test with Monthly Reports
3 Year Shelf Life Test with Monthly Reports
5 Year Shelf Life Test with Monthly Reports
8 Year Shelf Life Test with Monthly Reports
ASTM Accelerated Aging Testing
ISO 11607 Part 1 requires shelf life studies to demonstrate that sterile barrier packaging systems are capable of maintaining sterile barrier integrity through claimed expiration dates. While the FDA does require real-time shelf life studies to be undertaken, they will allow product to be approved for sale on the market sooner based on the results of accelerated shelf life studies.
QRA INT'L provides ASTM F1980 testing to evaluate the long-term effects on packaging in a compressed timeline. The results of accelerated aging testing are used to support shelf-life claims until data becomes available from real time aging studies.
Full and detailed monthly reports are provided with Calibration Reports for compliance submissions to relevant authorities.
Some Common Accelerated Aging Tests
Accelerated Aging 2 Year Equivalent with Monthly Reports
Accelerated Aging 3 Year Equivalent with Monthly Reports
Accelerated Aging 5 Year Equivalent with Monthly Reports
Accelerated Aging 8 Year Equivalent with Monthly Reports
Industry Application
Accelerated Aging per ASTM F1980 is a standard that provides guidance for how to develop accelerated aging protocols. Accelerated aging works by putting samples in a chamber and applying heat and/or humidity for a predetermined amount of time, usually weeks or months. For example, the most common temperature used in sterile barrier packaging validation is 55 °C. Assuming standard considerations of the real-world storage environment, then it will only take 40 days in hot conditioning to simulate a full 365 days (1 year) of real-world storage time.
If medical device manufacturers had to wait for their real-time aging data before they could go to market with their shelf life claim, there would be a drastic halt in medical device innovation. Therefore, the FDA will accept accelerated aging data for your medical device shelf life claim as long as real-time aging testing is performed in parallel to confirm accelerated aging findings.
The typical temperatures used to test by most medical engineers are 50°C, 55°C, and 60°C. It is important, however, to consider the materials of construction when determining the test specifications.
QRA's Aging Calculator is a great tool to estimate how many days your study will require. If you have questions about the accelerated aging of your sterile medical device packaging, we are ready to discuss your project to recommend the best course of action.
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