121.c to 124.c is standered value for sterilization?sometimes temp exceed to 126.c is allow?
if 121 to 124 is standard value as per vallidation then 126 degree is overshoot temperature. it is not allowable. if your autoclave properly set for 121-124 temperature , it will not reach at 126.
Tnx sir but at time of sip same problem create temp reach 126 to 127 that also not allowble?
Sir,i want to join your asked question.
Sir recently we have validation of SIP cycle.
It is validated by range of 121-131°c .
As per autoclave guidance its standard for autoclave steam sterilzer 121+3,126+3, 131+3.
Depending upon your requirements.
But in case of SIP cycle we have to only sterlie the equipment with its connecting lines. So there is no impact if your temp rises to 126. Bz of we have to sterlization the equipment , free from bioburden .
Please , take care of following points.
1* you have to mention in your standard perameters while submitting your Dossier/ NDA
2* Imact assessment study
3* Risk assessment study
4*This should be justified pharmacopoeia requirements 6 log reduction with biological challenge.
Applicable only Filter SIP , MFG Vessels SIP