ETO Sterilization Chamber Testing

Temperature and Humidity Distribution Testing

ETO 殺菌室嘅溫度設定範圍應該係30-60 ° C 之間。建議進行殺菌器內表面嘅溫度分佈測試同埋殺菌室內嘅溫濕度分佈測試，以確保加熱同加濕系統嘅有效性。

a) Internal Surface Temperature Test of ETO Sterilization Chamber:

During the test, the sterilization chamber should be empty, but auxiliary devices required for sterilization can be installed. The sterilization chamber door should be closed.
The temperature of any preheating stage as specified by the sterilizer manufacturer should be recorded. The temperature of all internal surfaces of the sterilization chamber should not exceed the set temperature of the sterilization phase by ±5°C.

b) Temperature and Humidity Test in the ETO Sterilization Chamber:

During the test, the ETO Sterilization Chamber should be empty, but auxiliary devices required for sterilization can be installed. The sterilization chamber door should be closed.
Use temperature and humidity sensors placed in specified positions to compare with the control temperature inside the chamber. The temperature sensors should be placed at locations likely to represent the maximum temperature differences, such as unheated parts of the chamber, near the cabinet doors, and near steam or gas entry points. Other sensors should be evenly distributed throughout the usable volume of the sterilization chamber, including the middle, top, bottom, front, and rear. The number of sensors should meet the requirements in Appendix C of GB18279.1.
The position of each measurement should be recorded, and the temperature and humidity in different areas of the sterilization chamber should be recorded to identify potential hot spots and cold spots.
The indoor temperature range of the sterilization chamber when empty should not exceed ±2°C of the set temperature or ±3°C of the average temperature inside the chamber.

Vacuum Pumping Rate

The vacuum system during the vacuum pumping phase should be able to evacuate the empty sterilization chamber to -75 kPa or lower. A pressure gauge should be connected to the vacuum test inlet to observe whether it meets the required standard.
The manufacturer should confirm the time required to reach -50 kPa and -75 kPa under empty load conditions. A timing device can be used to monitor the vacuum pumping phase, and the preset parameters should be reached within the specified time.

ETO Sterilization Cabinet Leakage Test

The ETO Sterilization Cabinet leakage test includes both vacuum (negative pressure) leakage testing and pressure (positive pressure) leakage testing (if applicable). When the sterilizer’s working pressure is greater than 5 kPa, a pressure (positive pressure) leakage test should be performed.

真空洩漏試驗應於滅菌劑注入階段及加濕階段前進行，測試方法遵循 YY0503 附件 D .1 之規定。試驗期間嘅預設壓力應該小於 -20 kPa ，並且至少低過預設嘅殺菌壓力20 kPa 。一旦達到預設壓力，所有連接到殺菌室嘅閥都應該關閉，真空泵應該停止工作。應監測殺菌室內嘅壓力，5分鐘內嘅壓力上升唔應該超過0.3 kPa / min 。整個測試期間嘅壓力變化唔應該超過0.1 kPa / min 。
Positive pressure leakage testing (if applicable) should be conducted before the vacuum pumping phase. The preset pressure for the test should be within 10% of the sterilizer’s preset working pressure. The pressure drop within 5 minutes should not exceed 0.3 kPa/min. At the same time, according to the method in Appendix D.2 of YY0503, the sterilization time should be set to at least 65 minutes, using inert gas (such as air) to replace EO gas and run a normal sterilization cycle. After the sterilization phase reaches temperature stability for 2 minutes, the pressure in the sterilization chamber should be recorded. It should be recorded again after 60 minutes ± 1 minute. The pressure variation rate should not exceed 0.1 kPa/min.Auxiliary System Verification

During the operational verification, the performance of related auxiliary systems should be confirmed, including but not limited to: the quality of steam provided, the ability of the EO vaporizer to reach the minimum gas input temperature, the reliability of the sterilizer’s air filtration and water supply systems, and the ability of the steam generator to maintain the required supply quality under maximum sterilization load conditions.

Examples of acceptable auxiliary system performance: a) When steam is injected during the processing phase, the humidity in the sterilization chamber should show a noticeable change, and the chamber should maintain pressure within ±2.5 kPa of the set pressure. b) The temperature of the injected EO gas should be higher than the minimum value set for the vaporizer (usually 10.7°C at atmospheric pressure) to ensure that the EO injected is in gaseous form, not liquid. c) The filtration effectiveness of the air filtration system should meet the requirement of a filtration rate of at least 99.5% for particles greater than 0.3 microns. d) The water supply system should use purified water meeting the requirements of the 2020 edition of the Chinese Pharmacopoeia. e) The steam vapor pressure used for humidification in the sterilizer should not exceed 50 kPa.

ETO 殺菌櫃軟件

喺殺菌過程中，殺菌設備軟件會控制同監控殺菌過程，並評估殺菌週期嘅參數。因此，喺運行資格過程中，應該喺所有故障條件（例如電腦化測量同控制系統）下測試殺菌設備軟件。參考殺菌器嘅使用手冊同設備規格，並喺挑戰設備運作極限嘅條件下測試軟件系統嘅功能，例如警報處理、錯誤處理、資訊管理、參數設定、歷史記錄介面、感應器控制同監控，以及運作控制同監控。