Steridox-12TM
The Steridox-12 is a chlorine dioxide gas sterilizer designed for use in any pharmaceutical, Medical Device manufacturing, laboratory, or research setting. It is available in a variety of sizes ranging from multiple cubic feet to multiple pallets. The Steridox-12 provides a rapid and highly effective method to sterilize medical devices, sterile products, instruments, and components at ambient temperatures. It utilizes a rugged industrial control system and the machine is constructed of robust, corrosion resistant 316L stainless steel to provide an exceptionally long life.
The Steridox-12 features a sophisticated photometric sterilant concentration monitoring system allowing for a tightly controlled and consistent sterilization process. This repeatable and accurate concentration monitoring system allows for tight process control, making chlorine dioxide gas sterilization cycles easy to validate. When sterilization cycles are completed, a run record is produced that contains cycle data including the date, cycle time, cycle steps, as well as temperature, pressure, and chlorine dioxide concentration. Run Data can also be electronically logged to the included USB and SD drives. The control system features a password protected, recipe management system with historical and real time trending of cycle data. All instrumentation, including the concentration monitoring system, can be easily calibrated to traceable standards.
With gaseous chlorine dioxide as the sterilant, it is economically beneficial to sterilize the Medical Devices in-house at either your facility or at your Contract Manufacturer. Most Medical Device manufacturers do not want to perform in-house sterilization utilizing EtO because of the liabilities of having a carcinogenic and explosive compound on site. The cost of a system, including the Damage Limiting Construction (DLC) featuring walls that are built to explode outward and Class 1 Div. 1 electrical installation, is extremely expensive. A Steridox-12 CD Gas system on the other hand has none of those costs or liabilities. Cycles are quick and simple being as short as a couple of hours in many cases. No special rooms for extensive aeration are required. The whole process takes place in a singular sterilization chamber which can safely be located anywhere in your facility.
ClorDiSys partners with many chamber manufacturers and can provide custom Steridox chambers based on your specific needs. Sizing can range from multiple cubic feet to multiple pallets.
ClorDiSys is easy to work with and can assist with both Cycle Development and Validation to enable the use of CD to be as simple as possible. CD is very similar to EtO in how it is utilized, the type of devices that can be sterilized, and the SAL sterilization levels that can be attained. An integrated UV-VIS spectrophotometer measures and controls the gas concentration ensuring the efficacy of every cycle and allowing for parametric release. Both are gasses but CD is not explosive or carcinogenic and leaves no harsh residues. CD cycle times are much shorter. ClorDiSys has a draft Device Master Reference file available as a guide. Devices can be packaged in Tyvek pouches, display boxes, or final shipping containers. Final corrugated shipping containers require a significantly more robust cycle. CD is friendly to most materials and electronics. Hand-held battery powered devices are an ideal candidate and present a significant issue for EtO. Datwyler has also successfully performed extensive testing on various stopper components.
An ideal application of utilizing a CD Steridox sterilizer in-house is placing it at the end of a production line and sterilize your devices in the clamshell packaging or the display boxes at the end of each shift. For higher throughput, a sterilization cycle can be performed half way through a shift and then again at the end of a shift due to typically shorter cycles.
CD Generation and Control modules are also available to convert existing SS sterilization chambers into a CD sterilizer.
Download the Steridox-12 Brochure
Chlorine Dioxide Gas Sterilization
Chlorine dioxide is unparalleled in its ability to effectively decontaminate. Being a true gas, it is unaffected by temperature changes, room configuration, chamber loads, has excellent penetration and distribution properties and is an EPA registered sterilant.
Advanced Concentration Monitoring
ClorDiSys' Steridox-12 features a sophisticated real-time chlorine dioxide gas concentration monitoring system to ensure a tightly controlled decontamination process.
Vacuum and Ambient Cycles
The Steridox-12 has to ability to sterilize items at either ambient or at vacuum pressures.
Printing and USB Data Logging
The Steridox-12 utilizes a USB drive to keep track of all cycle parameters during a decontamination. This data can then be downloaded to any database software. A printed run record can also be provided with the included printer.