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Revalidation of EO Sterilization
Revalidation of EO Sterilization
This article reviews some of the factors to consider when you are evaluating the need
for EO sterilization re-validation.
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ISO 11135-1:2014 is the international standard for sterilization validation for Ethylene
Oxide (EO or EtO) sterilizers. The standard describes multiple methods of sterilization
validation: 1) overkill approach, 2) single lot release, and 3) parametric release. The
overkill approach is the most common method for validation of your EO sterilization
process. If you are using a contract sterilizer, the sterilizer will already have completed
an Installation Qualification (IQ) and an Operational Qualification (OQ). You will need
to complete a Performance Qualification (PQ) for your product. A typical PQ for initial
process validation consists of the following:
1. Process Challenge Device (PCD) validation
2. Bioburden measurement
3. EO residual measurement (as per ISO 10993-7:2008/R2012)
4. Fractional Cycle (at least one)
5. 3 Half Cycles
6. 3 Full Cycles (or 1 Full Cycle, if performed in parallel with the three half-cycles)
Most contract sterilizers already have one or more Process Challenge Devices (PCDs)
that they have developed, and they may evaluate multiple PCDs in your fractional cycle
to determine which PCDs are more challenging to kill than an internal biological
indicator (BI). In addition to the above “typical” PQ, you might also choose to validate
partial loads and/or re-sterilization of product in the case of rework.
Re-validation of EO Sterilization – When is re-validation required?
In the ISO 11135 standard, #4 and #5 are referred to as the microbial performance
qualification (MPQ), while #6 is referred to as the physical performance qualification
(PPQ). For a successful MPQ, at least some of the PCDs must be non-sterile after a
fractional cycle to demonstrate the ability to recover the BI challenge organism. After a
half-cycle, however, all biological indicators should be sterile.