ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980 evaluates the integrity of sterile barrier medical systems. As an ISTA and ISO 17025 certified lab, Keystone Compliance realizes the importance of ASTM F1980 flexible sterile barrier testing. Meeting the ASTM F1980 pouch sterile barrier requirements can be difficult. We understand the challenges and guide companies through the process.
When packages do not meet the requirements, Keystone assists with finding solutions. We are in constant communication throughout the test process. Additionally, our proven process helps avoid product launch delays.
Summary of ASTM F1980 Regulatory Compliance
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 test method. However, methods such as those mentioned above are not beyond the expertise of Keystone’s engineers. For more information on Keystone’s broad package testing scope, contact us.
Scope of ASTM F1980 Flexible Packaging and Sterile Barrier Regulatory Compliance
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 as long as the package is undamaged or unopened, the manufacturer must demonstrate that 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.
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 provides an accelerated aging calculator to determine the accelerated test time equivalent of shelf-life testing.
Expert Regulatory Compliance ASTM F1980 Flexible Barrier and Pouch Sterile Laboratory Testing
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.
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.