C.1 Temperature Testing of Inner Surfaces in the eto Sterilization Chamber
C.1.1
The temperature of representative areas on the inner surfaces should be measured and recorded using temperature recording instruments that comply with the requirements of Appendix B.
C.1.2
Each inner surface must be measured at least once (i.e., a minimum of 6 synchronous measurement points). For sterilizers with a total volume between 300 L and 8000 L, each surface should be measured at least 2 times. For every additional 4000 L of total volume, an additional 6 synchronous measurement points should be added.
C.1.3
This test should be conducted with the eto sterilization chamber empty and doors closed, although auxiliary devices necessary for the eo sterilization process may be installed in the chamber.
C.1.4
The temperature specified for any preheating stage by the manufacturer should be recorded.
C.2 Temperature Testing of Empty eto Sterilization Chamber
C.2.1
Using temperature recording instruments that comply with Appendix B, the temperature of representative areas in the usable space of the eo sterilization chamber should be recorded.
C.2.2
There should be at least 6 synchronous measurement points. For sterilizers with a total volume between 300 L and 8000 L, at least 12 simultaneous measurements should be made; for every additional 4000 L, an additional 6 synchronous measurement points should be added. Note that the measurement area should include regions within the usable Ethylene oxide sterilization chamber space where temperature fluctuations may be extremely large (areas with extreme temperature variations), such as unheated areas near the sterilization chamber door and areas close to the steam injection points.
C.2.3
During testing, the sterilization chamber should be empty but may have auxiliary devices necessary for the Ethylene oxide sterilization process installed, with the doors of the Ethylene oxide sterilization chamber closed.
C.2.4
Throughout the entire Ethylene oxide sterilization cycle, the location of each temperature measurement should be recorded, detailing the temperatures in various areas of the eo sterilization chamber.
Note: This test may use non-toxic, non-flammable gases or mixtures as substitutes for the sterilizing agent injected into the eto sterilization chamber via the ethylene oxide injection system (including vaporizer).
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