noiembrie 2024

În sensul acestui document, următorii termeni și definiții se aplică în sterilizarea cu oxid de etilenă. 3.1 Partea de aerare a […]

Inspecția aspectului: Verificați dacă există daune pe suprafețele mașinii principale, a raftului de control și a dulapului de comandă electric.
Verificarea sursei de alimentare: Asigurați-vă că sursa de alimentare îndeplinește cerințele și verificați direcția de rotație a pompei de apă și a pompei de vid.
Porniți alimentarea și observați dacă valorile afișate a instrumentului sunt normale; în caz contrar, întrerupeți alimentarea, inspectați și reparați înainte de a reporni.
Pipeline Inspection: Check for leaks in the water supply, vacuum, and medication delivery pipelines, and ensure all valves are in standby mode; adjust if necessary.

2.1.1 The overall shape should be precise, with smooth, clean surfaces and uniform color. There should be no burrs, sharp edges, cracks, visible scratches, or unevenness.
2.1.2 All external text, graphics, and symbols must be printed clearly, with precise and durable markings.
2.1.3 Fasteners must be securely installed. All control switches and adjustment knobs (or buttons) should operate smoothly and reliably without obstructions.

Within a certain range of gas concentration, the higher the concentration, the better theEO Gas Sterilization effect; beyond 1000 mg/L, the improvement in sterilization effect is not significant.

eto sterilization technologies vs others: Advantages and Disadvantages Sterilization is a critical process in infection control, ensuring that medical instruments

The temperature setting range of the ETO Sterilization Chamber should be between 30-60°C. It is recommended to perform temperature distribution testing of the sterilizer’s internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.

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 Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters. It is typically a device or test package containing biological indicators (e.g., Bacillus atrophaeus spores with known spore count). The resistance of the PCD to the sterilization process should be greater than or equal to the resistance of the natural microbial load in the most difficult-to-sterilize area of the product. The quantity of PCDs should meet the requirements outlined in Table C.3 of Appendix C in GB18279.1-2015. PCDs are classified into Internal PCDs (IPCD) and External PCDs (EPCD).

Industry Eto Sterilizer Installation Verification The installation of Industry Eto Sterilizer and all associated services should comply with the requirements

The humidification water used in the ETO Sterilization Equipment should be free from contaminants, should not weaken the ETO sterilization process, and should not damage the sterilizer, sterilized products, or the load. Humidification should be done by injecting steam, not by directly injecting atomized water.