Re: Gap analysis for ISO 11135-1994 and 2007
Hello all,
I do not have a formal gap analysis, but I do have a lot of experience with EO sterilization validations. The main difference in the ISO11135 1995 to 2007 version is the addition of a requirement for a Fractional (Sub –lethal) Cycle to your validation runs. Also, this cycle has to be run at least every 24 months along with the annual re-validation. This is a cycle with a shortened EO dwell time duration (Less than a half-cycle time) when compared to the full cycle and with all other parameters constant. This cycle should produce biological indicator growth with no natural product sterility (NPS) growth and will be run to validate the biological recovery process as per ISO 11135-1: 2007. The involvement of this cycle is to fulfill the requirement to demonstrate that the natural product sterility (NPS) samples are less of a challenge to EO sterilization than the biological indicators (BI’s).