More F The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.
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It offers multiple aging protocols to determine the effects of time on the sterile integrity of the packaging as well as the physical properties of the latter. While this guide does evaluate the sterile barrier system shelf life, it does not address the barrier system material and device interaction compatibility. Use and factors to be considered The aging of products or materials refers to the variation of their properties over time.
The properties of interest are those related to safety and efficacy. An aging study is a procedure that seeks the determination of the behavior of a device under normal-usage conditions over a relatively long time by exposing the material for a short period of time to an external stress, which is more severe or more frequently applied than normal environmental stresses.
According to the latter, aging processes increase as a function of the ambient temperature. This function states that any chemical reaction will double its rate with each 10 oC increase. For additional information about Arrhenius law, please see; Heat Aging Testing.
Medical devices need to be able to be stored for an extended period without any decrease in performance that may influence safety and efficacy when used. The ability of product designers to predict in a precise way the changes in polymer properties is therefore crucial and this standard guide provides sufficient evidence for claimed expiry date until data from real time aging studies are available.
The loss of sterile barrier system integrity can be the result of the deterioration of physical properties of the materials, the degradation of adhesive or cohesive bonds as well as the subsequent dynamic events during shipping and handling. Furthermore, a given polymer may have many functional chemical groups organized in various ways glass, amorphous, crystalline as well as additives, processing agents, catalyst, lubricants, residual solvents, corrosive gases and fillers.
These elements combined with variations in end-use conditions and storage environment influence the degradation chemistry. Typically between 20 oC and 25 oC.
Accelerated aging temperature: To be specified, but typically below 60 oC since higher temperature may induce nonlinear changes. Accelerated aging factor: To be specified. Post-Aging evaluation The sterile barrier system that have been subjected to aging are evaluated for both physical properties and integrity to assess whether or not product properties were modified or adversely compromised compared to the unexposed one.
Mechanical tests such as tensile properties and other physical tests tailored to your specific needs should be considered at different time intervals during the accelerated aging process. We will be happy to answer your questions and help you with your testing requirements.