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. Scope of ASTM F ➢Provides information for developing accelerated aging protocols. ➢Information may be used to support shelf life and expiration date.
Ambient Temperature Warehouse Temperature Higher temp. Historical Astmm s – view previous versions of standard. 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. Shelf Life Study Equivalent. The expiry date of a medical product is commonly based on its manufacture date. UPS Overnight, Account number.
Try out our Accelerated Astj Calculator! The sterile barrier system shall maintain sterility to the point of use or until the expiry date. The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:.
ASTM F procedure for accelerated aging is comprised of the following: 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.
Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. For more information visit www. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Fed-Ex 2 nd day, Account number. In parallel, age samples at real-life aging conditions TRT. If f1980-0 different Temperature and or Temperature Humidity condition is required than listed above or more then 30 cubic feet of boxes, contact RMTS for Pricing at Please fill-in your Input Temperatures and select the Q10 value.
UPS Ground, Account number. To receive an Official Detailed Quote, please fill-in the following fields. r1980-07
Therefore, some add an extra month to the aging study to allow for sterilization, etc. Accelerated Aging Test Results. Please ship all samples with this form to: For example, a 12 month shelf life is simulated based on 13 months.
ASTM-F – Accelerated Aging – Medical Package Testing
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. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Evaluate the package performance after accelerated aging relative to the initial package requirements.
Pricing includes monthly temperature graph reports. Accelerated aging studies can provide an alternative means.
Age samples at TAA. Work Item s – proposed revisions of this standard. If you have questions about our online quoting process or other questions or need assistance, call RMTS at Link to Active This atm will always route to the current Active version of the standard.
Online Quote System – Accelerated Aging
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. Accelerated Aging Temperature Higher temp. 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. Relative Humidity RH is not a factor in the Arrhenius equation.
Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. Determining AAFs are beyond the scope of this guide. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. 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.
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Please fill out this form and return with your Product Submission.
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