ASTM F offers multiple aging protocols to determine the effects of time on the sterile integrity and the physical properties of medical packaging. The ASTM F guide provides documentation for developing accelerated aging protocols to promptly determine the effects, if any at all, due to the passage of. Scope of ASTM F • Significance and Use. • Understanding Accelerated Theory & Rationale. • Tolerances and Precision. • Cautions Using Accelerated.
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Evaluate the package performance after accelerated aging relative to the initial package requirements. In parallel, age samples at real-life aging conditions TRT.
The sterile barrier system shall maintain sterility to the point of use or until the expiry date.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. 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.
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.
ASTM F procedure for accelerated aging is comprised of the following: 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.
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. 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.
Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements.
Real time studies must be carried out to the claimed shelf life of the product and be g1980 to their completion. ASTM-F Standard D1980 for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.
The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Accelerated aging studies can provide an alternative means.
Historical Version s – view previous versions of standard. For more information visit www. Aztm Item s – proposed revisions of this standard. Define aging test time intervals including time zero. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
Determining AAFs are beyond the scope of this guide. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. 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.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Try out our Accelerated Aging Calculator!
Link to Active This link will always qstm to the current Active version of the standard. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Age samples at TAA.