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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 CD 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 can take place in a single sterilization chamber which can be located anywhere within your facility. Our CD gas is registered with US Environmental Protection Agency as a sterilant (Registration# 80802-1) and is able to inactivate all forms of antimicrobial life, including spores.

ClorDiSys and CD gas make it easy to bring the sterilization of medical devices in-house. ClorDiSys partners with many chamber manufacturers and can provide custom CD Gas Sterilization 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 Gas Sterilization Chamber in-house is placing it at the end of a production line to 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.

In-house treatment costs can be as low as $5 per load.

CD Gas vs. EtO

CD gas has been providing true sterilization for medical devices for over 25 years. While EtO is a very effective sterilant, CD gas has many benefits over EtO for a variety of applications. Both are gasses which have the ability to reach all of the individual organisms to provide desired SAL levels utilizing 6-log sporicidal BI’s. The CD gas concentration can easily be measured with a built-in UV-VIS spectrophotometer ensuring the efficacy of every cycle and allowing for parametric release. Unlike vapor methods, Chlorine dioxide, being a gas, offers repeatable and consistent kill. Unlike some novel gas methods, CD has over 25 years of use since it was developed by Johnson & Johnson for sterilizing suture products, artificial joints, and implantable contact lenses.

Chlorine dioxide is the method usually recommended when devices have imbedded batteries which are not affected by CD. CD does not get absorbed into materials like EtO does, so an aeration time of under 30 minutes is typical. Chlorine dioxide is a true sterilant gas and works at true ambient temperature. The boiling point of CD is low, at -40°C. CD gas will not condense on devices. It is a surface sterilant, therefore CD gas can sterilize prefilled syringes, while maintaining drug integrity, and medical devices with complex geometries.

CD is also not listed as a carcinogen. In almost all locations, it can simply be exhausted to the environment rather than needing to be scrubbed with hazardous solutions. It is non-flammable and non-explosive at use concentrations, so it does not require expensive damage limiting construction.