Instech Systems

  What is an ETO Sterilizer? An  ETO sterilizer  is a device designed to sterilize items that are sensitive to moisture and high temperatures, such as plastic packaging, electronic components, and certain medical devices. Ethylene oxide, the key agent used in these sterilizers, is highly effective in killing microorganisms, including bacteria, viruses, and fungi, making it ideal for items that cannot withstand traditional steam sterilization. How Does an ETO Sterilizer Work? The process of ethylene oxide sterilization involves several stages: Preconditioning:  The items to be sterilized are placed in the sterilization chamber, where temperature and humidity are carefully controlled to ensure the optimal conditions for the ethylene oxide to penetrate the materials. Sterilization:  Ethylene oxide gas is introduced into the chamber. It diffuses through the materials and penetrates packaging to kill microorganisms by disrupting their cellular processes. Aeration: ...

  What is ETO Sterilization? Ethylene oxide (ETO) sterilization  is a process used to sterilize medical and pharmaceutical products that cannot withstand traditional high-temperature steam sterilization methods. ETO is a gas that effectively kills microorganisms such as bacteria, viruses, and fungi by disrupting their DNA and cellular proteins. How Does ETO Sterilization Work? Preparation : Items to be sterilized are placed in a sealed chamber. Exposure : ETO gas is introduced into the chamber, reaching all surfaces of the items. Conditioning : The gas is held at specific temperature, humidity, and pressure levels for a predetermined time to ensure effective sterilization. Aeration : Post-sterilization, the chamber is aerated to remove residual ETO gas, as ETO is toxic and potentially carcinogenic. Monitoring : Throughout the process, parameters such as gas concentration, temperature, and exposure time are closely monitored to ensure efficacy and safety. Applications of ETO St...

  21 CFR Part 11 compliant software   refers to software systems that adhere to the regulations outlined in Title 21 of the Code of Federal Regulations (CFR), Part 11, which governs electronic records and electronic signatures in the context of the pharmaceutical, biotechnology, and medical device industries regulated by the Food and Drug Administration (FDA) in the United States. Here are the key components and requirements of 21 CFR Part 11 compliance for software systems: Electronic Records:  The regulation requires that electronic records be trustworthy, reliable, and equivalent to paper records. This includes ensuring the accuracy, integrity, and availability of electronic records throughout their lifecycle. Electronic Signatures:  Part 11 establishes criteria for electronic signatures, ensuring that they are legally binding and equivalent to handwritten signatures. Electronic signatures must be unique to the individual, verifiable, and securely managed to preve...