Degradation of the physical properties of sterile medical device packaging materials over time and degradation of materials at bonding or thermal junctions over time and dynamic events in subsequent transportation and handlingThis may result in a loss of integrity of the sterile barrier system. Therefore, it is extremely necessary to test the packagingReal-time aging programTo ensure that the sterile barrier system material and the integrity of the sterile barrier system do not degrade over timeThe best data is provided
However, under the market conditions of rapid product updates, new products need to be put on the market in the shortest possible time, and real-time aging research cannot meet this purpose. Accelerated aging studies offer another alternative approach. In this article, we will talk to you about how to design the packaging of sterile medical devicesAccelerated aging test
This should be based on the characterization of medical devices and sterile barrier system materialsConsider temperature limitsTo ensure that the initial conserved aging endons are suitable, the temperature used for the test should be determined according to the characterization of the packaging material and the expected storage conditions. Material characterization and composition are factors in establishing the temperature limit for accelerated agingThe temperature should be selected to avoid any physical transformation of the material. Choose a room temperature or ambient temperature that is representative of the actual storage and use conditions of the product. （Note:The temperature is usually 20-25, and a temperature of 25 is considered a conservative value).3.On the basis of material characterization, the accelerated aging temperature is selected. The higher the accelerated aging temperature, the greater the accelerated aging factor, and thus the shorter the accelerated aging time. It should be noted that the accelerated aging time cannot be shortened by increasing the accelerated aging temperature uncontrollably. Excessively high temperatures may have an effect on the material that is not possible at real-time temperature or room temperature. The aging temperature should be selected according to the following guidelines:The aging temperature is accelerated by considering the thermal conversion temperature of the materialIt should be lowerany materialsTransition temperatureor below a sterile barrier systemDeformation temperature
Accelerated aging temperatureNo more than 60unless higher temperatures are proven to be suitable;
Note 1:Temperatures above 60 are not recommended because of the high probability of nonlinear changes such as percent crystallinity, free radical formation, and peroxide degradation in many polymerization systems.
Note 2:If testing a sterile barrier system containing liquids or other volatile components, a lower temperature may be required for safety reasons.
Note 3:The limit deviation of the acceptable test temperature is -2 and the limit deviation of the relative humidity is +5%, due to the shelf life of the finished product of the sterile barrier system in the accelerated aging protocol is 2A conservative aging factor of 0, any prolonged deviation below the specified temperature in the protocol can be compensated for by increasing the total duration of the test, so as not to invalidate the intent of the aging protocol.
Note 4:When the test temperature deviates for a long time, the effect of that temperature on the packaging material needs to be evaluated, and the adjustments required to achieve the desired shelf life estimate for the test period.
When the material characterization indicatesIt is not feasible to increase the aging temperature, you can only select itReal-time aging