S
s.parakos
Our Sterilization validation report (gamma irradiation at 25kGy) contains the average bioburden on the samples tested, upon which the dose was set.
During regular bioburden monitoring the level obviously fluctuates. I was wondering if there is a rule of thumb which says what range is acceptable and at what level an investigation into the bioburden/dose setting should be triggered?
eg If 10 x the average bioburben is measured during monitoring an investigation is required.
thanks
Simon
During regular bioburden monitoring the level obviously fluctuates. I was wondering if there is a rule of thumb which says what range is acceptable and at what level an investigation into the bioburden/dose setting should be triggered?
eg If 10 x the average bioburben is measured during monitoring an investigation is required.
thanks
Simon