Bioburden Count Question - Bioburden is above the alert limit >1 CFU/component avg.

[iaqgal]

I am trying to interpret a lab report - it states that the bioburden is above the alert limit >1 CFU/component average. Also states: number of samples negative on sterility test 100. How can they have 100% sterile product but still have Aerobic bacteria counts above 1 CFU?
Thank you!

 

[Ronen E]

Re: Bioburden Count Question - Bioburden is above the alert limit >1 CFU/component av

I am trying to interpret a lab report - it states that the bioburden is above the alert limit >1 CFU/component average. Also states: number of samples negative on sterility test 100. How can they have 100% sterile product but still have Aerobic bacteria counts above 1 CFU?
Thank you!

Hello and welcome to the cove

Bio-burden and sterility are 2 different tests, for 2 different purposes. BB testing is done on pre-sterilisation units to determine the load at sterilisation process entry. Sterility testing is done on post-sterilisation units to ascertain its effectiveness. Basically the mentioned process may be OK for now but if the warning signs are ignored it may deteriorate, or even fail without deteriorating any further, because "sterility" is a probability based concept and in big-enough numbers you could get a non-sterile (at least 1 viable micro-organism) unit.

Cheers,
Ronen.