Due to the passage of time on the sterile integrity of the sterile barrier system, as defined in the ISO 1980 standard, ASTM F16-11607 published by the American Society for Testing and Materials (ASTM), there is an interest in developing accelerated aging protocols to immediately determine the effects, if any, on the physical properties of component packaging materials. information is provided.
Information derived from this standard is used to support expiration date requests for medical device sterile barrier systems. The accelerated aging guideline addresses sterile barrier systems with or without devices as a whole. Sterile barrier system material and device interaction compatibility required for new product development or eventual evaluation are not addressed in this standard.
Real-time aging protocols are beyond the scope of this standard. However, real-time aging studies are essential to validate accelerated aging test results using the same evaluation methods. Methods used for sterile barrier system verification, including machine process, effects of the sterilization process, environmental challenges, distribution, handling and shipping, are not covered by this standard.
In addition, this standard does not address environmental challenges in the shipping and handling environment that warn of extreme climatic conditions. The ASTM D4332 standard is followed for the standard conditions used to force the sterile barrier system to realistic extremes in temperature and humidity conditions.
The introduction of new or modified products requires assurance that they can be stored for many years without any degradation of performance that would affect safety and efficacy during use. Until full-term or real-time aged samples are available, accelerated aging testing is imperative to present experimental data that supports performance and shelf-life claims for these products. These test methods are described in the ASTM F1980-16 standard. Information from these tests is used to support expiration date claims for medical device sterile barrier systems.
Among the numerous tests, measurements, analyses, and evaluations our organization provides for businesses in various sectors, we also offer standard testing services for accelerated aging of sterile barrier systems for medical devices under the ASTM F1980-16 standard, utilizing a trained and expert staff and advanced technological equipment.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
