ASTM F1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices:
The integrity of the sterile barrier is a critical factor in the medical field. Its degradation can occur due to the physical properties of materials, adhesives that gradually degrade over time, or even during product shipping and handling. In accordance with ISO 11607 standard, the packaging of a medical product must provide physical protection to maintain the integrity of the sterile barrier until its use or expiration date.
Stability testing, using accelerated aging protocols involving temperature and humidity, is an important method for anticipating product durability and providing quick results. However, it should be noted that real-time aging provides the most accurate and reliable data to ensure the integrity of the sterile barrier.
Nevertheless, considering the current market conditions where a product can quickly become obsolete, it is sometimes necessary to find a compromise between real-time aging testing and accelerated aging testing. The latter is conducted in parallel with real-time aging tests and allows for faster results.
The challenge lies in choosing the best Accelerated Aging Factor (AAF) to ensure the best correlation between real-time and accelerated aging. A factor that is too high may result in degradation of the packaging during accelerated testing, whereas it would not have degraded during real-time testing. This could invalidate packaging solutions that would be perfectly adequate under real conditions.
Therefore, it is essential to balance and control the parameters of accelerated aging to obtain accurate results and avoid the unnecessary rejection of potentially valid solutions. This delicate balance highlights the importance of proper application of ASTM F1980 standard in the medical and pharmaceutical industry.
This standard is inseparable from the testing for the approval of the integrity of the sterile barrier and validation testing for transport suitability.