ASTM F1980 Accelerated Shelf-Life Testing of Sterile Barrier Systems
When applied to package validation and ANSI/AAMI/ISO 11607 guidelines, accelerated aging can aid in decreasing time to market a new product. Typical standards guides and protocols may include ASTM F1980, ISO 11607-1 and ISO 11607-2.
ASTM F1980 gives you information for developing accelerated aging protocols and supporting expiration date claims for medical devices. The standard identifies the effects of the passage of time on the integrity of the sterile barrier system (SBS).
As an ISTA and ISO 17025 certified lab, we realize the importance of accelerated aging of sterile barrier testing. Meeting the accelerated aging test requirements can be difficult. We understand the challenges and guide companies through the process.
Keystone Package Testing partners with customers to achieve package compliance. We are in constant communication throughout the test process. Request a quote to receive testing services customized to your specific needs. Have a question about accelerated aging? Contact us and we will determine the best course of action.
Summary of ASTM F1980 Accelerated Aging Information
ASTM F1980 examines the physical properties of your packaging system. The protocol also helps you determine and defend expiration date claims for medical devices.
On the other hand, the accelerated aging procedures address the passage 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 this testing.
Scope of ASTM F1980 Sterile Barrier Systems Testing
Oftentimes, a sterile barrier system (SBS) has an expiration date because sterility can no longer be guaranteed for the full shelf life of the product. Over time, the adhesive materials or cohesive bonds that maintain sterility begin to degrade and the package is compromised.
These terms give you the foundation you need when developing accelerated aging protocols for your own packaging system:
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.
ASTM F1980 Testing for Accelerated Aging Testing Procedures
To begin testing, the laboratory will obtain the appropriate number of samples of the Sterile Barrier Systems. Additionally, the lab 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.
Next, you set the aging temperature. This is typically determined based on real-life storage temperature, estimated usage temperature, and humidity conditions. Furthermore, The room is equipped with a control apparatus, hygrometer, and thermometer.
You set samples 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.
At the conclusion of testing, our lab writes a comprehensive report following the guidelines outlined. Information included in the report consist of:
- Accelerated aging conditions: test temperature, humidity, cycle, ambient temperature
- List of equipment used for the physical testing
- Document of post-aging results
Significance of ASTM F1980 Accelerated Aging Testing
Why is accelerated aging Important? Accelerated aging is important for several reasons.
Firstly, F1980 helps assess the long-term performance and durability of sterile barrier systems, such as medical packaging, by simulating the effects of time in a shorter period. This enables manufacturers to evaluate the integrity and reliability of their products and make informed decisions about their shelf life and expiration dates.
Additionally, accelerated aging testing conducted in compliance with ASTM F1980 is often required for regulatory compliance, ensuring that products meet industry standards and regulations for safety and efficacy.
Expert Accelerated Aging and Sterile Barrier Package Testing
Keystone has a full lab of test equipment which permits us to provide short lead times on scheduling. We can accommodate flexible and rigid packages of all sizes, including large pallets. Our team strives to give our customers more time and energy on product development instead of testing.
Keystone Package has created an accelerated aging calculator to assist in the finding the number of days needed to perform testing. For more information, visit: Accelerated Aging Time Calculator
Contact us to learn first hand why so many companies partner with Keystone to achieve their sterile barrier certification needs.
For more referenced ASTM standards and similar testing, please follow the links below:
- ASTM D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM E337 Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures)
- ASTM F17 Terminology Relating to Flexible Barrier Packaging
- ASTM F1327 Terminology Relating to Barrier Materials for Medical Packaging
- ASTM F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
- ANSI/AAMI/ISO 11607–1: 2006, Packaging for Terminally Sterilized Medical Devices
Interested in the EMC/EMI, climatic, dynamic, shielding effectiveness, or IP Code testing of a product? Follow the corresponding links or www.keystonecompliance.com for more information.