ASTM F1980 – Accelerated Aging Laboratory Testing of Medical Devices
When applied to package validation and ANSI/AAMI/ISO 11607 guidelines, accelerated aging can aid in decreasing the time to market a new product. Typical procedures and protocols may include ASTM F1980, ISO 11607-1 and ISO 11607-2.
ASTM F1980 Accelerated Shelf-Life Testing of Sterile Barrier Systems
ASTM F1980 identifies how periods of time affect the integrity of sterile barriers and physical packaging components. As an ISTA and ISO 17025 certified lab, we realize the importance of accelerated aging of sterile barrier testing. Meeting the ASTM F1980 accelerated aging test requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone provides the peace of mind that all of your needs will be met. When packages do not meet the requirements, we assist with finding solutions.
Request a quote to receive testing services customized to your specific needs. Have a question about ASTM F1980 accelerated aging and medical device package validation? Contact us and we will determine the best course of action.
Summary of ASTM F1980 Accelerated Aging Information
ASTM 1980 regulatory compliance testing examines the physical properties of the flexible packaging materials, sacks, pouches, bags, and other medical apparatus. The ASTM F1980 protocol is also useful in determining and defending expiration dates.
The accelerated aging protocol only addresses the passing of time on the sterility of a sterile barrier system (SBS). It cannot be used when evaluating factors such as environmental challenges, distribution, handling, or shipping. It is imperative that real-time aging studies are performed to confirm the results of ASTM F1980.
Scope of ASTM F1980 Sterile Barrier Systems Testing
Oftentimes, 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.
Keystone provides an accelerated aging calculator to determine the accelerated test time equivalent of shelf-life testing.
Before package integrity 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
Significance of ASTM F1980 Testing for Accelerated Aging
To begin testing, the laboratory will obtain the appropriate number of samples of the Sterile Barrier Systems. The laboratory should be 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 equation reaction rate. This reaction rate can be used to increase temperature and cut down aging time.
Expert ASTM F1980 Accelerated Aging and Sterile Barrier Package Testing
In addition to ASTM F1980 flexible package and pouch sterile barrier testing, Keystone has a full scope of expertise including leak penetration, high impact shock, and cold chain. We can accommodate flexible and rigid packages of all sizes, including large pallets. Keystone has a full lab of test equipment which permits us to provide short lead times on scheduling.
Contact us to learn first hand why so many companies partner with Keystone to achieve their sterile barrier certification needs. Ready to get started? Request a quote to receive expert package sustainable integrity testing services tailored to your specific needs.