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Accelerated Aging Testing from DDL

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Dan Dossen
Dan Dossen

This document provides guidance on developing accelerated aging protocols for medical device packaging to support shelf-life and expiration date claims. It discusses accelerated aging theory, which assumes degradation reactions follow Arrhenius kinetics, allowing elevated temperatures to accelerate aging. A conservative Q10 value is recommended due to complex multi-component materials. Cautions are described, as reaction rates may not be linear above 50°C and different failure modes could occur. Real time testing should still be conducted in parallel.

NegóciosSaúde e medicina
1 de 23
ACCELERATED AGING PROTOCOL
Introduction ,[object Object],[object Object],[object Object]
Scope ,[object Object],[object Object],[object Object],[object Object]
Significance and Use ,[object Object],[object Object],[object Object],[object Object],[object Object]
Accelerated Aging Theory ,[object Object],[object Object],[object Object],[object Object]
Accelerated Aging Rationale ,[object Object],[object Object]
Accelerated Aging Rationale ,[object Object],[object Object]
Most package AA validation protocols are based on… ,[object Object],[object Object],[object Object]
Arrhenius Reaction Rate Theory states... “ a rise in temperature of 10 o C will double the rate of a chemical reaction ” So... AAR (Accelerated Aging Rate) = Q 10 ((Te - Ta)/10) Where... Ta = Ambient Temperature Te = Elevated Temperature Q 10 = Reaction Rate = 2 And... AATD (Accelerated Aging Time Duration) = Desired Real Time AAR
FOR EXAMPLE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Accelerated Aging Equivalency Matrix
[object Object]
Cautions in Using Accelerated Aging Theory ,[object Object],[object Object]
Cautions in Using Accelerated Aging Theory ,[object Object],[object Object]
Cautions in Using Accelerated Aging Theory ,[object Object],[object Object]
Cautions in Using Accelerated Aging Theory ,[object Object]
Other Test Methods ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Advanced Methods ,[object Object],[object Object],[object Object],[object Object]
Post Aging Testing Guidance ,[object Object],[object Object],[object Object],[object Object]
Conclusions ,[object Object],[object Object]
Conclusions ,[object Object],[object Object]
Conclusions ,[object Object],[object Object]
[object Object]

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Accelerated Aging Testing from DDL

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  • 9. Arrhenius Reaction Rate Theory states... “ a rise in temperature of 10 o C will double the rate of a chemical reaction ” So... AAR (Accelerated Aging Rate) = Q 10 ((Te - Ta)/10) Where... Ta = Ambient Temperature Te = Elevated Temperature Q 10 = Reaction Rate = 2 And... AATD (Accelerated Aging Time Duration) = Desired Real Time AAR
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