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Significance and Use
The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.
ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. 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.”
Real time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade 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. 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.
Conservative accelerated aging factors (AAFs) must be used if little is known about the sterile barrier system material being evaluated. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials. 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, Q10) and is tentative until the results of real time aging studies are completed on the sterile barrier system.
Note 1—Determining AAFs are beyond the scope of this guide.
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 and the physical properties of their component packaging materials.
1.2 Information obtained using this guide may be used to support expiration date claims for medical device sterile barrier systems.
1.3 The accelerated aging guideline addresses the sterile barrier systems in whole with or without devices. 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.
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
1.5 Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process, environmental challenge, distribution, handling, and shipping events, are beyond the scope of this guide.
1.6 This guide does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F1327 for a definition of “environmental challenging.”
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
E337 Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures)
F17 Terminology Relating to Flexible Barrier Packaging
F1327 Terminology Relating to Barrier Materials for Medical Packaging
F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ICS Number Code 11.080.30 (Sterilized packages)
UNSPSC Code 24120000(Packaging materials)