Buy ASTM F (R) GUIDE FOR ACCELERATED AGING OF STERILE BARRIER SYSTEMS FOR MEDICAL DEVICES from SAI. Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging. 1 This guide is under the jurisdiction of ASTM Committee F02 on Primary Last previous edition approved in as F – 07().
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Evaluate package, or package performance, or both, after real time aging relative to the initial astk requirements.
The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:. Age samples at TAA. Try out our Accelerated Aging Calculator! To receive an Official Detailed Quote, please fill-in the following fields.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: Online Quote System – Accelerated Aging.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
In parallel, age samples at real-life aging conditions TRT. Therefore, some add an extra month to the aging study to allow for sterilization, etc. Define aging asgm time intervals including time zero. 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.
The expiry date of a medical product is commonly based on its manufacture date. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. If you have questions about our online quoting process or other questions or need assistance, call RMTS at To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
ASTM-F Standard Guide 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. Fed-Ex Ground, Account number. Fed-Ex 2 nd day, Account number. Accelerated Aging Temperature Higher temp. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.
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.
Determining AAFs are beyond the scope of this guide. 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.
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.
Online Quote System – Accelerated Aging
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. For more information visit www. Please ship all samples with this form to: Fed-Ex Overnight, Account number.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Accelerated Aging Test Results.
Historical Version s – view previous versions of standard. Please fill-in your Input Temperatures and select the Q10 value. Please fill out this form and return with your Product Submission. 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.
Work Item s – proposed revisions of this standard. Pricing includes monthly temperature graph reports.
UPS 2 nd day, Account number. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Link to Active This link will always route to the current Active version of the standard. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Accelerated aging studies can provide an alternative means.
UPS Overnight, Account number. Shelf Life Study Equivalent. For example, a 12 month shelf life is simulated based on 13 months.