As per the guidelines we have to validate the performance of DHS at 250 deg for 30 min. hold time. therfore the set temperature value should be 250. But if by setting 250 we are not acheiving 250 deg inside the chamber, can we set it at different temp. or otherwise what should be the criteria…
when you set the temp. of DHS for depyrogenation of Ampoule/Vials. it is not necessary that you get same temp. our main aim to achiving the depyrogenation. so we having the certain acceptance limit for temp. +/- 10 degree ( Limit will be in house as per machine performance)
so we are taking the biological indicator and endotoxin test. for confirming the sterilization and depyrogenation.
any quire mail me
In USP it is clearly mentioned that the dry heat sterilization temp. should be ±15 degree when operating at 250 deg.
the limit Of temp. +/- 10 degree is taking the in house , for safety pupose .
i knowing the limit 0f 15 degree.