工业 Eto 灭菌器安装验证
The installation of Industry Eto Sterilizer and all associated services should comply with the requirements of the construction and engineering drawings. It is recommended to verify the components of the Industry Eto Sterilizer to ensure the installation meets applicable standards and requirements. These equipment components include:
3.2.3.1 Pre-treatment Area (if applicable)
a) Structure of the cabinet and doors;
b) Air circulation system;
c) Airflow monitoring equipment and alarm system;
d) Temperature and humidity monitoring and control system.
3.2.3.2 Industry Eto Sterilizer
a) Structure of the cabinet and doors;
b) Sealing and connections of the cabinet and piping system, ensuring no leakage;
c) Calibration of instruments for monitoring, controlling, indicating, or recording parameters (e.g., temperature, humidity, pressure, and EO concentration) such as sensors, recorders, pressure gauges, and testing equipment;
d) Gas and liquid supply systems (e.g., air, nitrogen, steam, EO, and water), including filters (if used);
e) Power supply system, ensuring adequate, stable, and continuous power for the operation of equipment and instruments;
f) Gas circulation system;
g) Gas injection system;
h) Vacuum system, including pumps, pump cooling system, and piping;
i) Exhaust, emission control, and reduction systems;
j) Other critical systems that may affect process conditions, such as process automation systems, safety systems, etc.
3.2.3.3 Decontamination Area
a) Structure of the cabinet and doors;
b) Air recirculation equipment;
c) Airflow monitoring equipment and alarm system;
d) Temperature monitoring and control system.
If forced decontamination is applied externally to the sterilizer, it is recommended to verify the qualifications of the decontamination chamber’s contractor, drawings, standard operating procedures, spare parts list, etc.
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