Hello guys, could you help me?
The standard ISO 11135: 2014, item B.1.4, says that the resistance of the product's bioburden must be less than the resistance of BI. I read the guide (item D.14.1.4), but I still have doubts about how I could run the tests to meet this item.
The standard talks about a fractional cycle and the sterility test after the cycle, but if there is growth in the BI and the product, how can I guarantee that the BI is still more resistant? Should the exposure time of this fractional cycle be defined to allow BI growth? Should I use product samples as if it were a routine sterilization? And how do I define the sampling?
If someone has another test suggestion to ensure that the BI is more resistant than the product's bioburden, please share. I will be very grateful for your support.
Thank you in advance.
The standard ISO 11135: 2014, item B.1.4, says that the resistance of the product's bioburden must be less than the resistance of BI. I read the guide (item D.14.1.4), but I still have doubts about how I could run the tests to meet this item.
The standard talks about a fractional cycle and the sterility test after the cycle, but if there is growth in the BI and the product, how can I guarantee that the BI is still more resistant? Should the exposure time of this fractional cycle be defined to allow BI growth? Should I use product samples as if it were a routine sterilization? And how do I define the sampling?
If someone has another test suggestion to ensure that the BI is more resistant than the product's bioburden, please share. I will be very grateful for your support.
Thank you in advance.