Validating to be processes
The organism forms a shell-like structure to protect itself until a nutrient-rich environment becomes available, at which time it can sporulate, grow and reproduce,” said Littley.
“Once we get to performance qualification, you are looking for repeatability and reproducibility of the cycle for a particular process challenge.” The common approach for ethylene oxide sterilization (EO sterilization) validation is referred to as the “Overkill Approach,” in which a biological indicator, placed in the most resistant location of the device, is deactivated or killed in one-half the time of the routine sterilization cycle.“When the dwell period ends, it is important to exhaust the EO out of the load and devices due to the flammability as well as because it is a carcinogen,” said Littley.To remove most of the EO gas before opening the chamber, the load is washed with an inert gas such as nitrogen or steam, until most of the EO is out.The half cycle’s lethality must be demonstrated a minimum of three times to be considered adequate or validated.
Additionally, a full cycle is performed to demonstrate that the defined cycle is capable of maintaining the process parameters for the entirety of the routine production cycle.
According to Littley, there are two ways to verify the resistance.