Decontamination of medical devices using supercritical CO2

The quality of cleaning and decontamination of medical devices using supercritical CO2 outstrips that of detergent cleaning currently used in cleanrooms.

Decontaminate, degrease and pre-sterilise your medical devices with a single environmentally-friendly process

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Supercritical CO2 is compatible with all metals, polymers and materials of human or animal origin.

Supercritical CO2 is chemically neutral. It is therefore unlikely to oxidise or react chemically with metals and most polymers.
In its supercritical phase, CO2 combines the characteristics of a gas and a liquid: it has the diffusion power of a gas and the viscosity of a liquid. As a result, it can come into contact with all the surfaces of a metal part and diffuse deep into polymers without affecting their mechanical or chemical properties.

This supercritical CO2 is ideal for degreasing and decontaminating a variety of parts, whether they have been machined, drawn, deburred, injected or turned.

It can also be used to clean and decontaminate heat-sensitive polymers, as well as animal and human tissues, whether in powder, bone, fragment or other form.

Finally, supercritical CO2 is perfectly suited to the treatment of medical devices, whether textiles, silicone, plastics, bi-materials or intelligent medical devices.

It is a stable process that remains constant over time

To reach and exceed the critical point of supercritical CO2, two parameters are important: pressure and temperature. These two parameters are defined before a cycle is launched and managed automatically by the machine.
The process is ultra-stable and ultra-repeatable, ensuring impeccable cleaning quality that lasts over time.

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No drying of parts or decontaminated materials required

The supercritical CO2 cleaning and decontamination process is a completely dry treatment. It uses carbon dioxide which, at the end of the treatment, becomes gaseous again and disappears completely from the surface of the parts or materials treated. So you can forget about the problems of retaining solvents or water in cavities or blind holes.

No drying is required.

In addition, supercritical CO2 is a low-temperature process, which is generally between 35 and 55°C in order to ensure the preservation of heat-sensitive polymers and biomaterials.

At the end of the treatment, the treated parts or materials are at room temperature and can be handled without delay.

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Get pre-sterilisation for your medical devices

Supercritical CO2 is also known to have a strong effect on the biological load present on parts. It can be used to pre-sterilise implantable or non-implantable, single-use or reusable medical devices.

Supercritical CO2 causes a series of changes that are lethal to living organisms: acidification of the extra- and intracellular pH, changes to the cell membrane, disruption of enzyme activity and electrolyte balance, etc.

The treatment both cleans and decontaminates medical devices. This pre-sterilisation action will enable you to reduce exposure time during the final sterilisation operation using processes currently approved by the health authorities.

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Adopt an effective solution for decontaminating your medical devices now.

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Our speciality : Machines designed for cleanrooms

L'une de nos spécialités est la conception et la fabrication de machines de nettoyage et décontamination de dispositifs médicaux parfaitement adaptées aux besoins de l’industrie médicale : Autoclave de nettoyage et décontamination séparé du corps de machine pour implantation salle grise ou salle propre.

- Machine body can be moved to a neighbouring workshop up to 50 m away.
- Cleanable, oxidation-resistant materials (316L stainless steel) for the cleanroom/grey area.
- Grease-free door seal.
- Contaminants are collected in the machine body in the technical room to prevent contamination of the cleanroom.
- Possibility of double-door autoclave through the wall for one-way production flow from the grey room to the clean room.
- CFR part 11 compliance for command control. Includes access history and cycle traceability.

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Sterilisation using supercritical CO2, already possible in Europe, the USA and around the world

Supercritical CO2, the only non-toxic large-scale sterilisation process.

A sterilisation process whose objective is to reduce to 0.000001 (1 in 1 million) the probability of finding pathogenic micro-organisms on a medical device. Although a biocide, supercritical CO2 poses no danger to the environment or to the health of operators or patients.

Dense Fluid Degreasing offers healthcare manufacturers, hospitals, clinics and care centres a safe, stable sterilisation technology that can be industrialised.

The alternative to traditional sterilisation processes: supercritical CO2 sterilisation can replace traditional sterilisation processes
- Ethylene oxide (explosive, irritant, carcinogenic and mutagenic, with processing times of several days)
- Ionising radiation (requires nuclear facilities)
- Dry steam (danger of explosion and burns, incompatible with heat-sensitive materials)
- Cold plasma (explosive, unsuitable for most polymers, requires special packaging)

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Your questions?

Our answers!

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Is supercritical CO2 compatible with all materials?
Supercritical CO2 technology is based on the use of CO2 as a solvent. The supercritical phase of CO2 is obtained by pressurising and then heating the CO2. The supercritical phase requires a pressure of over 74 bar and a minimum temperature of 31°C. Dense Fluid Degreasing machines for decontaminating medical devices using supercritical CO2 are designed to operate at 150 Bar - 35°C or 300 Bar - 50°C. It is in these two sets of parameters that the density of supercritical CO2 and its solvent power are the highest.

Because it works at low temperature, supercritical CO2 is compatible with all metals and virtually all polymers used in implantable and non-implantable medical devices. Supercritical CO2 is chemically inert. It does not corrode metals or alter the properties of polymers during low-temperature treatment.

Supercritical CO2 decontamination technology is therefore compatible with all metals, including :
- steel and all its alloys
- titanium
- nickel
- aluminium
- gold
- tungsten
- neodymium, etc.

With most polymers, including :
- Polyester (PE)
- Polystyrene
- Polypropylene (PP)
- Polyethylene terephthalate (PET)
- Poly L-Lactic Acid (PLA, PDLA, PLLA)
- Viscose
- Elastane, etc.

As well as various other materials including :
- Silicones
- Bio-sourced materials, etc.

One of the only known incompatibilities of supercritical CO2 in relation to the medical device industry is with natural rubber and certain synthetic rubbers such as those used in the manufacture of syringe stoppers. These deform during treatment with supercritical CO2 and do not fully return to their original shape.

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What types of medical devices can supercritical CO2 decontaminate?
Unlike other technologies used to decontaminate medical and implantable medical devices, supercritical CO2 is highly versatile. This technology can be used to decontaminate medical devices made of metal, polymers, biopolymers and textiles (natural or synthetic).

This process offers a number of advantages compared with other decontamination processes commonly used in the medical device industry:

1. on average, the decontamination time is 30 minutes to 1 hour, compared with several hours required for other processes.
2. at low temperatures, it is compatible with all materials
3. it does not require drying, which means significant savings in electricity consumption
4. Supercritical CO2 has a pre-sterilising effect, reducing the biological load by 4 to 5 Log without any additional action.
5. at the end of treatment, no trace of CO2 remains on the surface of the treated materials.
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Is supercritical CO2 compatible with use in cleanrooms?
Qarboon specialises in supercritical CO2 cleaning and decontamination machines for cleanrooms. For cleanrooms, there are two possible options :

1. our machines can be broken down into several components. See the range of machines dedicated to the medical industry. The technical unit is then separated from the autoclave block or cleaning chamber, allowing the autoclave alone to be installed in the cleanroom.
2. Our machines can be designed to be installed through a wall. The autoclave is fitted with two doors, one for loading from a grey room or workshop, the other serving the cleanroom.Whichever option is chosen, the technical unit can be up to 50 metres away from its autoclave(s).

If supercritical CO2 is used in a cleanroom, the ventilation system must be able to evacuate the CO2 in addition to the other flows normally managed, in the event of an emergency shutdown.
In both configurations, our machines comply with ISO regulations.
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