Accelerated stability of medical devices

#1
Hi dear,

I have a question about the accelerated stability and that we will start for our products (class IIa), the specific standard for our products provides the temperature ranges to be used and also the Arrhenius equation to calculate the aging period. In this pattern, he says that we should have “Adequate Controlled Humidity” throughout the study, but he does not describe which humidity range we should use. We will conduct the study at 60 ° C, our climate chamber has a humidity range of 20% to 90%. I am in doubt about which range of controlled humidity should I use. Does anyone know how to refer to a standard or from experience, what humidity should I use?
 
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#2
Hi Gilbert,
The standard RH for real time aging (25C) is 60% RH and for accelerated aging (45C) is 75% RH.

See the ICH stability document for further guidance.
Q1a(R2) Stability Testing of New Drug Substances and Products
 
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