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:

Ein Process Challenge Device (PCD) ist ein mikrobiologisches Challenge-System, das zur Bewertung der Abtötungsrate ausgewählter Prozessparameter verwendet wird. Typischerweise handelt es sich um ein Gerät oder eine Testpackung, die biologische Indikatoren enthält (z. B. Bacillus atrophaeus-Sporen mit bekannter Sporenzahl). Die Beständigkeit des PCD gegenüber dem Sterilisationsprozess sollte größer oder gleich der Beständigkeit der natürlichen mikrobiellen Belastung im am schwierigsten zu sterilisierenden Bereich des Produkts sein. Die Menge an PCDs sollte den in Tabelle C.3 von Anhang C in GB18279.1-2015 aufgeführten Anforderungen entsprechen. PCDs werden in interne PCDs (IPCD) und externe PCDs (EPCD) unterteilt.

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.

Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd., commonly referred to as HZBOCON, stands out as a dedicated Ethylene Oxide (EO/ETO) sterilizer manufacturer. Established in 2006, HZBOCON has committed itself to the design, development, and manufacturing of EO sterilization equipment, catering to a wide array of industries that require effective sterilization solutions for thermosensitive products.

PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.

In OQ, the performance of the relevant auxiliary system should be determined and the software system should be tested by simulating the fault conditions.

a.Equipment to be used in the sterilization process, including any ancillary items, shall comply with its design specifications.The corresponding documents include functional design specifications, user requirements specifications, design drawings, etc. (Equipment schematic diagram, energy supply diagram, electrical schematic diagram, system schematic diagram, etc.)

Ethylene oxide sterilizer operate at low temperatures, making them ideal for sterilizing heat-sensitive medical devices and instruments. This characteristic allows for the preservation of the integrity and functionality of complex medical devices that might be damaged by heat.

Protection mechanism and explanation OF ETO Sterilizer System 2. By default, the system will perform the leak detection test before