Relevant to ISO11135:2014

[komal bhavsar]

ISO 11135:2014 guidelines : Can we use chamber volumes in deciding the number of Biological Indicators to be kept for routine sterilization

 

[chris1price]

Yes, take a look at Annex C.3, and the table C.3

The minimum recommended number of BI/PCDs to use is as follows:
a) For MPQ with a product load volume of up to 10 m3, use three BIs per m3 of product volume, with a minimum of five BIs.
b) For MPQ with a product load volume above 10 m3, use one additional BI per additional m3 beyond 10m3.
If BIs are used for routine control use half the number of BIs used during MPQ up to a maximum of 30.
The result of the calculation should be rounded to the next higher number.

 

[komal bhavsar]

Yes, take a look at Annex C.3, and the table C.3

The minimum recommended number of BI/PCDs to use is as follows:
a) For MPQ with a product load volume of up to 10 m3, use three BIs per m3 of product volume, with a minimum of five BIs.
b) For MPQ with a product load volume above 10 m3, use one additional BI per additional m3 beyond 10m3.
If BIs are used for routine control use half the number of BIs used during MPQ up to a maximum of 30.
The result of the calculation should be rounded to the next higher number.

 

[komal bhavsar]

Thankyou sir for your response.. but in Annexure C it is mentioned as product load volume instead of EtO sterilizer chamber size.. hence is it that product load volume is equivalent to chamber size?

 

[chris1price]

That's a good point. I have always tried to fill the chamber with as much product as possible, and the volume should be consistent. If you base your calculation on the "usable chamber volume", you will be safe in your calculation.

 

[komal bhavsar]

That's a good point. I have always tried to fill the chamber with as much product as possible, and the volume should be consistent. If you base your calculation on the "usable chamber volume", you will be safe in your calculation.

Ok sir.. thanks a lot