प्रक्रिया चॅलेंज डिव्हाइस (पीसीडी) ही एक मायक्रोबायोलॉजिकल चॅलेंज सिस्टम आहे जी निवडलेल्या प्रक्रियेच्या पॅरामीटर्सच्या किल रेटचे मूल्यांकन करण्यासाठी वापरली जाते. हे सामान्यत: एक डिव्हाइस किंवा चाचणी पॅकेज आहे ज्यात जैविक निर्देशक आहेत (उदा. ज्ञात बीजाणू मोजणीसह बॅसिलस rop ट्रोफायस बीजाणू). पीसीडीचा प्रतिकार नसबंदी प्रक्रियेचा प्रतिकार उत्पादनाच्या सर्वात कठीण क्षेत्रातील नैसर्गिक मायक्रोबियल लोडच्या प्रतिकारापेक्षा जास्त किंवा समान असावा. जीबी 18279.1-2015 मध्ये परिशिष्ट सीच्या टेबल सी .3 मध्ये नमूद केलेल्या आवश्यकता पीसीडीच्या प्रमाणात पूर्ण केल्या पाहिजेत. पीसीडीएस अंतर्गत पीसीडी (आयपीसीडी) आणि बाह्य पीसीडी (ईपीसीडी) मध्ये वर्गीकृत केले जाते.

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.

OQ मध्ये, संबंधित सहाय्यक प्रणालीचे कार्यप्रदर्शन निर्धारित केले जावे आणि दोष परिस्थितीचे अनुकरण करून सॉफ्टवेअर प्रणालीची चाचणी केली जावी.

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