The correct operation of the sterilization cycle must be evaluated every time a cycle is carried out. In the case of steam processes, it is advisable to include at least three biological indicators per cycle, with a minimum frequency of one control every three cycles. For ethylene oxide, it is recommended that there be at least two biological indicators per cycle. In the case of dry heat, it is advisable to include at least three biological indicators per cycle, with a minimum frequency of one control every three cycles. It is important to notice that every time the processed biological indicators are incubated, an indicator that has not been processed should be included to assure that the growing conditions have been favorable enough during the whole sterilization cycle.
It is also worth considering that the more often biological indicators are used in a process, the more reliable will the cycle performance become.
Besides the usual controls, you should include biological indicators whenever:
– A new packaging material is used.
– After training a new staff.
– After a sterilizer has been repaired.
– After any change during the loading process of the sterilizer.
Content source:
Centers for Disease Control and Prevention,
ISO/TS 11139:2006 Sterilization of health care products
Please Check out file at the following link
Dry Heat Chemical Indicator class 6 (RRS 14-15610)
Steam Biological Indicator 10^5 (RRS 14-21110)
