Medical devices

The cleaning and decontamination of medical devices with supercritical CO2 outperforms the water-based cleaning currently used in clean rooms.

Decontaminate, degrease, pre-sterilize
your medical devices with a single cleaning process

The process allows for the thorough cleaning of any part that has just been machined, drawn or deburred. Whether it is tubes, syringes or any other machined or injected components, with metallic or polymeric composition.

Enjoy consistent quality for all metals and polymers

Supercritical CO2 is suitable for all metals and most polymers.
With Dense Fluid Degreasing machines, supercritical CO2 leaves no trace on the surface or inside the medical devices because when it returns to atmospheric pressure it becomes gaseous again.
Supercritical CO2 is chemically neutral: no risk of oxidation or chemical reaction with the materials of the parts.

This guarantees you a constant cleaning and decontamination quality 24 hours a day, 7 days a week.

The process allows for the thorough cleaning of any part that has just been machined, drawn or deburred. Whether it is tubes, syringes or any other machined or injected components, with metallic or polymeric composition.

No more drying steps thanks to CO2

The Dense Fluid Degreasing process is a dry treatment process and therefore does not require drying. at low temperatures, generally between 35 and 50 °C. The low processing temperature preserves the thermo-sensitive polymers and biomaterials.
It is therefore also possible to treat tissues of animal or human origin (e.g. bones, tendons, skin etc.)

Get a pre-sterilization of your MD

Supercritical CO2 is also known to have a strong action on the bioburden present on the parts. It allows to pre-sterilize the parts.

Indeed, supercritical CO2 causes a series of modifications that are lethal for living organisms: acidification of the extra and intracellular pH, modification of the cell membrane, disruption of enzymatic activity and electrolytic balance…

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

Scientific Publications

Numerous scientific publications testify to this action on various strains of bacteria or fungi, also in sporulated form.

Especially:
Gonçalo C.Soares et al, Supercritical CO2 technology: The next standard sterilization technique? Materials Science & Engineering C 99 (2019) 520-54

L. Garcia-Gonzalez et al, High pressure carbon dioxide inactivation of microorganisms in foods: the past, the present and the future. International Journal of Food Microbiology,117 (2007)
G. Bertoloni et al, Medical device disinfection by dense carbon dioxide, Journal of Hospital Infection 77 (2011) 42- 46

Self-finance your machine investment

Dense Fluid Degreasing machines self-finance themselves in 3 to 5 years, due to the drastic reduction in operating costs: energy consumption reduced by 50%, no water consumption, no need to reprocess polluted effluent and reduced processing times.

In the case of medical devices, the Dense Fluid Degreasing machines are designed for the clean room environment and offer on the top of that pre-sterilization.

Cut the cleaning time of your medical devices by 10
Reduce your operating costs by 4
Remove all traces of solvents or detergents
Benefit from a pre-sterilization

PLLA medical fabric braids degreased with supercritical CO2
PLLA medical fabric braids degreased with supercritical CO2

Special case

Medical implantable textiles

The Dense Fluid Degreasing process with supercritical CO2 has proven its effectiveness in removing sizing oil from textiles (between 2 and 2.5% of the textile’s mass), as an alternative to detergent and/or organic solvent processes (e.g. Soxhlet).
The current processes are long and costly (16 to 24 hours), leave solvent residues in the textiles, which requires costly monitoring and analysis. On polymers and implantable textiles, the efficiency of supercritical CO2 machines has been proven by tests and the results are :

Removal of sizing oil comparable to or greater than levels achieved with conventional processes ≤ 0.1%
No detergent addition, no residual solvent to monitor
Cleaning time divided by 10
Operating costs divided by 4 due to low temperature dry processing without drying
Strong decrease in bioburden with 4 to 5 log reduction

Example of implantable medical textiles cleaned and pre-sterilized with supercritical CO2.

PLLA medical fabric braids degreased with supercritical CO2

Tendon and ligament replacement braids

Implantable textiles plate

Suture thread spool

Through-the-wall cleaning for cleanrooms and medical devices

Dense Fluid Degreasing autoclave for clean room with automatic and safe opening.

Machines adapted to clean rooms

Dense Fluid Degreasing designs and manufactures cleaning machines perfectly adapted to the needs of the medical industry:

Autoclave for cleaning and decontamination separated from the machine body for grey room or clean room implementation
Machine body can be installed in a neighbouring workshop up to 50m away from the clean room
Cleanable and oxidation resistant materials (316L stainless steel) for the cleanroom/grey room
Greaseless door seal
Recovery of contaminants in the machine body located in a workshop to avoid contamination of the clean room
Possibility of double door through-the-wall autoclave for one-way production flow from the grey room to the clean room
CFR part 11 compliance for the control system. Includes access history and cycle tracking.

Discover other supercritical CO2 cleaning applications

Spool of desensitizing line - dense fluid degreasing

Application for textiles

Autoclaves that can accommodate widths up to 3m
Desensitization of textiles in bulk or on reels

Waste plastic to recycled - dense fluid degreasing

For recycling

Recycling of metal chips
Extraction of pollutant molecules from a polymer matrix

 

Engine Cylinder Head - Dense Fluid Degreasing

For the mechanics

Suitable for all metallic and polymeric materials
Ideal for complex parts Removes all residual traces of solvents