Medical Device

Our Validatable Series Automatic Ethylene Oxide Sterilizer are used by medical devices manufacturers manufacturing heat sensitive and heat labile medical devices which include long term invasive products like intra ocular lenses, cardiac pacemakers, vascular stents etc. They are floor standing, working in vacuum mode and use single use 100% E.O. cartridges for sterilization. The sterilization chamber is made from corrosion and gas resistant stainless steel. The inner surface of the chamber is smoothly finished to minimize any gas deposits and ensure a clean pleasing look. The chamber is electrically heated with our special ROTAHEAT arrangement and is insulated against heat emission.

The sterilizer door is hinged type, opening on the side and has a double latching arrangement with a quick release locking spring activated mechanism. To further ensure safety, a secondary locking arrangement gets activated once the CYCLE START button is activated which ensures that the door cannot be opened, once the CYCLE has started. A safety interlock is provided to ensure that the sterilization process does not start till the door is closed and latched.

To ensure smooth, silent and trouble free operation, the sterilizer is provided with an air motor vacuum pump which is used for vacuuming as well as degassing the sterilizer. As there are no moving or rotating parts in this pump, the maintenance is extremely low and it also ensures an almost silent and noiseless operation. It is a sturdy industrial model and the sterilization process can be validated as per EN ISO 11135 – 2014 standards for sterilization of medical devices. Already installed in many medical device manufacturing facilities who have been certified to USFDA, CE and other relevant medical compliance standards. Optionally we also offer 21 CFR Part - 11 Complaint Software and Recording.

Our Validatable Series sterilizers are especially custom designed for the application that they will be used for, with special software and hardware configurations and hence we offer different sterilizers for different industries. Our Validatable Series - Cardiac Stent Sterilizer is so very different from our Suture Industry Sterilizer.

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