In the pharmaceutical and medical device industry, contamination control and sterility are crucial components to maintaining the highest level of quality products expected of companies in these fields. ClorDiSys Solutions offers many chlorine dioxide based decontamination products and services to preserve your product integrity and trust. Our gaseous CD is gentle on materials and is the safest and most effective way to decontaminate your isolators, processing rooms, and passthroughs and is a direct replacement for EtO and hydrogen peroxide based systems.
Our chlorine dioxide gas is registered with US Environmental Protection Agency as a sterilant and is able to inactivate all forms of antimicrobial life, including spores. Our process has also been validated and proven to be effective at inactivating Beta-lactams including Penicillins, Cephalosporins, and Carbapenums allowing facilities of this type of contamination to be easily re-purposed. Download our paper from Applied Biosafety, Vol.16, No. 1, Chlorine Dioxide Gas Inactivation of Beta-Lactams for complete information.
Chlorine dioxide gas fills the space it's contained within completely and evenly, ensuring that no matter how large the target space is,
or how much equipment is within the space, no surface is left untouched. Traditional room decontamination times are approximately 2.5-3.5 hours depending
on their size and the accompanying air handling unit.
Examples of room types decontaminated with chlorine dioxide gas are:
Clean Rooms
Production Rooms
Packaging Rooms
Cold Rooms
Micro Labs
Gowning Rooms
Airlocks and Passthrough Rooms
For applications where the entire room does not need to be decontaminated, equipment can be tented and fumigated in place. This allows for a smaller
volume to be treated, lowering treatment times and costs compared to decontaminating the entire room. With a proper seal, production and other work can take place
in the same room as the tented equipment undergoing decontamination.
Available Products: ClorDiSys Decontamination Services | Cloridox-GMP | Minidox-M
Chlorine dioxide gas fills the space it's contained within completely and evenly, ensuring that no matter how large the target space is,
no surface is left untouched; including crevices and harbor locations. CD Gas has successfully treated many pharmaceutical facilities to eliminate viruses, bacteria, molds, and beta lactams from existing facilities.
New facilities, as well as facilities undergoing renovation, have been decontaminated to establish sterility prior to production starting up as well.
Case Study - Yearly Shutdown Decon
Yearly planned maintenance shutdowns create dirty environments since foreign equipment, tools, and people enter the clean areas. Previously, this 300,000 ft3 facility underwent three cycles of detergent cleaning and water rinse
followed by three treatments with Spor-Klenz. This required over a dozen personnel with mops and buckets over multiple shifts and a minimum of a week’s worth of time. The process was costly (consumables alone cost
approximately $100,000) and had inherent failures in the process since it was a laborious manual process. The facility switched to chlorine dioixide gas decontamination. The result was a disinfection cost of under $100,000;
a time savings cost of three days, and efficacy improved to a complete 6-log sporidical kill.
Case Study - Post Renovation Decon
A 35,000 ft3 facility was being completely renovated to update everything from its ventilation system to its equipment and casework. Prior to moving back into the facility, the area was decontaminated in
order to provide a guaranteed sterile environment for research. Decontamination took one day and included all rooms, hallways, and supporting ductwork. The floors above and below the facility were
occupied throughout the decon with no chlorine dioxide gas detected and no adverse effects seen.
ClorDiSys has also developed Decontamination Protocols to minimize downtime if a facility becomes contaminated with molds, MMV or other unwanted organisms. We can work with your Operations, Engineering, and QA
Personnel to develop a response plan and document it in a protocol. Advantages include: plan arranged prior to the actual crisis when resources are available and stress levels are low; time savings with a
simple phone call initiating action response; and cost savings with a pre-negotiated treatment cost.
Available Products: ClorDiSys Decontamination Services | Cloridox-GMP | Minidox-M
Chlorine dioxide gas (CD) is able to provide true sterilization, similar to EtO for medical devices. While EtO is a very effective sterilant, CD 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 6-log sporicidal kill. The CD concentration can
easily be measured with a built-in UV-VIS spectrophotometer ensuring the efficacy of every cycle and allowing for parametric release.
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.
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.
Treatment cost can be as low as $5 per load. Most devices would not require an expensive vacuum sterilization chamber, simply a sealed chamber such as an isolator
or box. FDA people are anxious to see its expanded use because of all of the benefits over non-gaseous methods.
Current Applications Include:
Implantable Contact Lenses
Artifical Joints
Suture Products
Bones and Bone Powders
Surgical Kits
Endoscopes
Available Products: Cloridox-GMP | Minidox-M | Decontamination Chamber | Isolators
Bringing equipment, tools and supplies into a barrer facility is a potential pathway for pathogens to enter your clean room. We have a few products which
can help eliminate pathogens in order to preserve the sterility of your barrier. Our CD Gas equipment can be used within a Decontamination Chamber or
combination Rack Washer/Decontamination Chamber to provide a six-log sporicidal reduction of all items being processed. We can also help design a Passthrough Room that can achieve
the same results without needing to purchase a chamber (see photos below). Items can include animal racks, electronics, HEPA filters, and many other items that cannot be autoclaved
into the facility. Passthrough rooms can also be designed and built into a facility, without the need to purchase a specialized chamber.
We also offer UV passthrough chambers and UV passthrough tunnels to disinfect small electronics, tools, and other items entering the clean room.
Available Products: Decontamination Chamber | CD Gas Passthrough Chambers | Flash-Thru Chamber | Flash Tunnel
For situations when the whole room does not need to be decontaminated, we offer a number of options for surface treatments. Liquid chlorine dioxide can be
used to fog, spray, or wipe surfaces down in order to disinfect or sterilize that location. Ultraviolet light can be used to disinfect the visible surfaces within a room,
whether they are benchtops and casework, or the common touch points on equipment.
Available Products: the Torch UV Disinfection | Lantern UV Disinfection | CSI-3000 | CD-Tabs
Chlorine dioxide gas decontamination of isolators is quick, residue free, and cycle development free. Isolators can be decontaminated
in under an hour whether they are empty or full of components. We also build custom isolators, as seen in the photo on the right. These can be nearly any size,
and have numerous options available.
One customer has been decontaminating their processing isolator (seen on left) with chlorine dioxide gas 2-3 times daily, totaling over 1000 decontaminations.
Available Products: Minidox-M | Minidox-B | Minidox-L | Passthrough Isolators
Traditional sanitation procedures typically do not include Air Handling Units or their accompanying ductwork. When decontaminating with CD gas,
it is often times very easy to include the ductwork and air handling system (even HEPA housings) in the scope of the project. CD gas penetrates through HEPA filters
as if they are not there, and being a dry gas it is able to navigate the bends and turns of the ductwork system without condensing and getting "stuck."
Available Products: ClorDiSys Decontamination Services | Megadox-P | Minidox-M
Chlorine dioxide gas has been shown to inactivate beta lactams, which you can read about by clicking here.
Since the initial laboratory testing, chlorine dioxide gas has been used at multiple leading pharmaceutical companies worldwide to inactivate beta lactams within their facility. Chlorine
dioxide gas treatment allows for areas and equipment previously used for beta lactam production to be used for non-beta lactam activities, saving lots of money compared to building new facilities.
Available Products: ClorDiSys Decontamination Services | Cloridox-GMP | Minidox-M
Biological Safety Cabinets are able to be decontaminated with chlorine dioxide gas quickly and effectively. We work with a number of Certification
companies around the world who certify and decontaminate Biological Safety Cabinets. To find the company nearest to you, please click here.
Chlorine dioxide gas has been used by multiple facilities to decontaminate vehicles and shipping containers. Shipping containers have been used as a decontamination chamber, where items
can be placed inside and decontaminated outside the area.
Our Cloridox-GMP can be used to connect up to autoclaves and run vacuum pressure chlorine dioxide gas decontaminations within the chamber.
Available Products: ClorDiSys Decontamination Services | Cloridox-GMP | Minidox-M