ETO-STERILISATOR

Een Process Challenge Device (PCD) is een microbiologisch testsysteem dat wordt gebruikt om het sterftepercentage van geselecteerde procesparameters te evalueren. Het is doorgaans een apparaat of testpakket dat biologische indicatoren bevat (bijvoorbeeld sporen van Bacillus atrofaeus met een bekend aantal sporen). De weerstand van de PCD tegen het sterilisatieproces moet groter zijn dan of gelijk zijn aan de weerstand van de natuurlijke microbiële belasting in het moeilijkst te steriliseren gebied van het product. De hoeveelheid PCD's moet voldoen aan de vereisten zoals uiteengezet in Tabel C.3 van Bijlage C in GB18279.1-2015. PCD's worden geclassificeerd in interne PCD's (IPCD) en externe PCD's (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.

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

1.Purpose for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been