Routine Monitoring and Control
The purpose of routine monitoring and control of EO (Ethylene Oxide) sterilization is to demonstrate that the confirmed and specified sterilization process has been applied to the product. Data from each sterilization cycle should be recorded and retained to prove that the confirmed sterilization process specifications have been met. This should include at least the following content:
a) Evidence that the environmental temperature of the product has reached the minimum confirmed temperature when entering the pretreatment (if used). This can be achieved by allowing the load to acclimate to the environment for a specified minimum time. If the storage temperature is known, there is no need to determine the temperature of the product before entering the pretreatment area. If the product has been exposed to extreme temperatures, such as during transportation, the product may need to be stored for a period before pretreatment to stabilize its internal temperature and humidity within an acceptable range.
b) Monitoring and recording of the temperature and humidity in the pretreatment area (if used) at specified locations.
c) The start time of the pretreatment for each sterilization load and the time the load is removed from the pretreatment area (if used).
d) The time interval between removing the sterilization load from the pretreatment area (if used) and the start of the sterilization cycle.
e) Indicators of proper operation of the gas circulation system in the chamber during the gas exposure phase (if used).
f) The temperature and pressure inside the chamber throughout the sterilization cycle.
g) The humidity inside the chamber during the processing phase, as measured by pressure or directly.
h) Confirmation that gaseous EO has been introduced into the sterilization chamber.
i) The pressure rise inside the sterilization chamber and the amount or concentration of EO used.
j) The processing time.
k) The exposure time.
l) Time, temperature, and pressure changes (if applicable) during the aeration phase and/or venting operations (if used).
EO Sterilization Release
a) Biological Indicator Method
If biological indicators (confirmed EPCD) are used, they should be distributed throughout the sterilization load, including the most difficult-to-sterilize locations or locations known to be related to these difficult spots. If pretreatment is used, the biological indicators should be placed before the pretreatment.
The biological indicators should be removed from the sterilization load after the sterilization cycle ends and cultured as soon as possible to allow the biological indicators to revive. If they are not cultured in a timely manner, the effects of exposure to residual EO during delayed revival should be evaluated.
The growth of the biological indicators should be analyzed to determine if the growth is not due to failure to meet the physical process specifications, which would require repeating the confirmation process.
b) Parameter Release Method
Parameter release relies on proving that all physical process parameters meet the specifications for release without the use of biological indicators. It is based solely on measurements and records of physical process parameters and serves as a sufficient declaration of the sterilization process’s adequacy.
Parameter release is only permissible when all process parameters are specified, controlled, and directly monitored. Therefore, when parameter release is used, there should be equipment for direct measurement of temperature and humidity inside the chamber and for direct analysis of EO concentration, to collect and record the sterilization process parameters and confirm that the sterilization process complies with the specifications.
In addition to proving that the sterilization process parameters meet the sterilization specifications, parameter release also requires measuring and recording the following additional data:
Measuring the temperature inside the chamber at least from two locations throughout the sterilization cycle.
Directly measuring the humidity inside the chamber during the processing phase.
Determining the EO concentration by direct analysis of the sterilization chamber’s gas at specified time intervals, to fully verify that the required conditions are met throughout the exposure period.
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