Package and product compatibility and interactions should be addressed as a material analysis process before package design. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. This standard is also available to be included in Standards Subscriptions.
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Historical Version s - view previous versions of standard. Work Item s - proposed revisions of this standard. 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. 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. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
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, Q 10 and is tentative until the results of real time aging studies are completed on the sterile barrier system. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.
Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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