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<h2>&nbsp;</h2>
<p>The overkill method involves overkilling reference microorganisms to demonstrate a certain level of sterility. It serves to validate sterilization and to sterilize reusable products. This approach supports a sterilization process designed to exceed the treatment required to achieve a specific level of sterility, accommodating variances in pre-sterilization microorganism burden during cleaning procedures. There are two types of overkill methods: a full cycle approach and a reduced treatment option known as a partial cycle approach, which includes the half cycle approach.</p>
<h2>Partial Cycle Approach</h2>
<p>For a partial cycle sterilization validation protocol, the extent of reduced treatment required to inactivate 10^6 microorganisms on an ISO 11138-3 compliant biological indicator (BI) is confirmed. This level of treatment is performed three times to establish reproducibility. By using the inactivation kinetics of the sterilizing agent and the number and resistance of the microorganisms on the BI, one can predict the likelihood of microorganism survival.</p>
<h2>Full Cycle Approach</h2>
<p>In the full cycle approach, the sterilization load should be exposed to the sterilizing agent under normal conditions designed to deliver a particular level of sterilization. The population on the biological indicators used should exceed by at least 0.5x log to the base of 10 of the population calculated from Fbio 12 and certified D121 value for the biological indicator.&nbsp;</p>
<p>Microorganisms with high resistance to moist heat suitable for use include G. sterarothermophilus, B. coagulans, C. sporogenes, and B. atrophaeus.</p>
<p>After exposure to the sterilizing agent for the normal cycle, the sterilization load is confirmed to have no survivors. Once a successful sterilization cycle is established, the overkill method is repeated twice more to confirm the repeatability of the process.</p>
<h2>Fbio Calculations</h2>
<p>Fbio = D121 (log No &ndash; log N)</p>
<p>Where:</p>
<p>D121 is the D value of a BI at an exposure temperature of 121&deg;C No is the pre-exposure viable population of the BI N is the post-exposure viable population of the BI</p>

Overkill Method For Sterilization Validation

Publish Time：2023-12-11