C.1 eto 殺菌室內表面嘅溫度測試

C.1.1

內表面代表性區域嘅溫度應使用符合附件 B 嘅要求嘅溫度記錄儀器測量同記錄。

C.1.2

每個內表面必須至少測量一次(即最少 6 個同步測量點)。對於總體積喺300升至8000升之間嘅殺菌器,每個表面應該至少測量2次。每增加 4000 L 嘅總體積,就應該額外增加 6 個同步測量點。

C.1.3

呢個測試應該係喺 eto 殺菌室空同門閂嘅情況下進行,雖然室內可能會安裝 eo 殺菌過程所需嘅輔助裝置。

C.1.4

應該記錄製造商為任何預熱階段指定嘅溫度。

C.2 空嘅 eto 殺菌室嘅溫度測試

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.

注意: 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).

如果您想了解更多關於環氧乙烷滅菌嘅信息

電話:+8619975258603

電子郵件:hayley@hzbocon.com

本地站點:中國浙江省杭州市下沙區蔡通中新1202室

網站:hzbocon.com zjbocon.com

碌到頂部