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. 1 Mar Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging.

Author: Fenrizahn Mikora
Country: Indonesia
Language: English (Spanish)
Genre: Art
Published (Last): 8 October 2012
Pages: 152
PDF File Size: 12.27 Mb
ePub File Size: 3.81 Mb
ISBN: 889-1-67617-252-4
Downloads: 32977
Price: Free* [*Free Regsitration Required]
Uploader: Nikolar

Work Item s – proposed revisions of this standard.

For more information visit www. Accelerated aging studies can provide an alternative means. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. Define aging test time intervals including time zero.

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 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. Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier f19800.

Evaluate the package performance after accelerated aging relative to the initial package requirements. Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. 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 shall maintain sterility to the point of use or until the expiry date.

Related Article:  LEVUCELL SC PDF

ASTM-F – Accelerated Aging – Medical Package Testing

Try out our Accelerated Aging Calculator! 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. Define package material properties, seal strength and integrity tests, sample f1908, and acceptance criteria.

Link to Active This link will always route to the current Active version of the standard. Age samples at TAA.

The resulting creation of an expiration date or shelf aatm 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. 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-F1980

In parallel, age samples at real-life aging conditions TRT. T1980 F procedure for accelerated aging is comprised of the following: 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.

Related Article:  KITAB DALAILUL KHAIRAT PDF

Determining AAFs are beyond the scope of this guide.

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are f19880 provided as part of the standard. 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.

F1908 aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging. Stability testing shall demonstrate that the sterile barrier system maintains integrity 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.

Historical Version s – view previous versions of standard. Real time studies must be carried out to the claimed shelf life of the product and be performed to their aztm.