Is there any possibility of sterility failure in case of accelerated condition?
Actually i have performed Sterility test of a batch of an injection, that time sterility test is pass but in stability study again i have performed the sterility test of a same batch so stability sample is sterile but accelerated sample is sterility failure?
So kindly tell me what is the reason behind this?
Definitely sir, temperature & Rh are main factors causing sterlity failures. Bz high humidity in high temperature cause vapourization inside sterlie product, and this causes hydrogen+ oxegen presence , leads to failure of sterity.
That is why recommended storage conditions are mentioned always.