To rapidly determine the effects of time on integrity of the sterile barrier system and the physical properties of their component packaging materials.
The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling. ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. 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.”
Real time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade over time. However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
Conservative accelerated aging factors (AAFs) must be used if little is known about the sterile barrier system material being evaluated. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials. The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of the aging factor (for example, Q10) and is
tentative until the results of real time aging studies are completed on the sterile barrier system.