ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980 provides information for developing accelerated aging protocols. The objective of ASTM F-1980 accelerated aging testing is to rapidly determine the effects, if any, due to two primary events. First, the passage of time. Second, the environmental effects on the sterile integrity of packages and the physical properties of their component packaging materials.
The information obtained using ASTM F1980 may also be used to support expiration date claims for medical device packages.
The ASTM F1980 accelerated aging guideline addresses the primary medical package in whole. This package testing standard does not address the package and product interaction or compatibility that may be required for new product development. Package and product compatibility and interactions should be addressed as a material analysis process before package design.
Real-time aging protocols are not addressed in ASTM F-1980, however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
Methods used for package process validation, which include the machine process, the effects of the sterilization process, distribution, handling, and shipping events, are beyond the scope of this ASTM accelerated aging package testing.
The ASTM F1980 sterile barrier test standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this packing standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
The loss of package integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.
It is important to note that the ANSI/AAMI/ISO 11607 standard states that, “the manufacturer shall demonstrate that, under the rigors of distribution, storage, handling, and aging, the integrity of the final package is maintained at least for the claimed shelf-life of the medical device under storage conditions specified by the manufacturer, as long as the package is undamaged or unopened.”
Real time aging programs provide the best data to ensure that package materials and package integrity do not degrade over time. However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective.
Accelerated aging studies provide an alternative means. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product.
Keystone Compliance provides ASTM F1980 aging testing in a professional, timely and affordable manner. Our package testing lab features multiple shakers and temperature chambers, so lead times on scheduling are never an issue.
Our lab also features EMC, product safety, wireless, package and ingress protection testing. Regardless of the testing need, Keystone Compliance can provide the solution.
For more information on our capabilities, please contact us. If you are ready to see firsthand why so many companies rely on Keystone Compliance for their ASTM F1980 medical device package testing, please request a quote.