Overview
FrançaisABSTRACT
Increasingly stringent environmental and regulatory constraints on chemicals (REACH), together with effluent disposal concerns, have prompted new cleaning processes and solutions (dry vapor, plasma, dry ice, etc.). Among these, the dry cleaning of mechanical parts or medical devices using supercritical carbon dioxide (SC) CO2 emerges as one of the most promising and efficient processes from the point of view of cleaning levels reached but also of economic, environmental and safety performance. This paper highlights the potential of SC CO2 cleaning, which could in the near future become the standard method for cleaning medical implants and mechanical parts.
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Read the articleAUTHORS
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Stéphane BREDEAU: Dense Fluid Degreasing SA (DFD), Clermont-Ferrand, France
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Julie CHAPELAIN: Dense Fluid Degreasing SA (DFD), Clermont-Ferrand, France
INTRODUCTION
Supercritical CO 2 (SC): a green solvent for extraction
Used on an industrial scale since the late 1970s for the extraction of natural products in cosmetics, nutraceuticals and the food industry, CO 2 SC has established itself as an alternative process to conventional solvent-based extraction from the petroleum industry. The first example of large-scale industrialization of this process concerns coffee decaffeination. CO 2 due to its physico-chemical properties (colorless, odorless, non-toxic, non-flammable) is indeed the most widely used supercritical fluid from an industrial point of view. Moreover, due to its moderate critical conditions (T c = 31 °C, P c = 73.8 bar), CO 2 SC very quickly emerged as a particularly suitable candidate for plant extraction, and in particular as an alternative to organochlorine solvents. It is as dense as a liquid, with gas-like transport properties. It can therefore be used as an apolar solvent to replace much less harmless chemicals (e.g. chloroform, trichloroethylene, perchloroethylene...). Since then, new applications for CO 2 SC in the cleaning of mechanical and medical parts have confirmed the fluid's potential as an alternative solvent of choice, not only for the removal of hydrophobic residues such as oils, lubricants and monomers, but also for its bactericidal and disinfectant action.
Respect for the environment and regulations (challenges)
Growing interest in environmental issues over the last few years has led to the emergence of innovative solutions that make a definitive commitment to sustainable development, in order to meet requirements in terms of environmental protection, public health and, what's more, to minimize the energy consumption of the processes developed. And above all, beyond the environmental and societal aspects, these processes must be economically profitable to be sustainable. For example, the use of organic solvents for cleaning mechanical parts or medical devices is subject to increasingly stringent restrictions, particularly since the implementation of the REACH directive (ban on the use of trichloroethylene since March 2016), in order to ensure a high level of protection for human health and the environment, against the risks that these chemicals can cause. These constraints are particularly important in the medical industry, so it's essential to offer alternative substances to the organic solvents classically used in cleaning processes. Treatment with supercritical...
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KEYWORDS
cleaning | supercritical CO2 | medical device
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Dry cleaning of medical devices by supercritical CO2
Bibliography
Websites
NIST (National Institute of Standards and Technology), Pure Bodies Database https://webbook.nist.gov/chemistry/fluid/ (page consulted on June 3, 2018)
Femto-physique website https://femto-physique.fr/physique_statistique/diffusion-moleculaire.php...
Events
Trade fair: Parts2Clean International cleaning trade fair, held every year in Stuttgart http://www.parts2clean.de/home
Standards and norms
- Salles propres et environnements maîtrisés apparentés : Partie 1 : Classification de la propreté particulaire de l'air - NF EN ISO 14644-1 - 2015
- Medical devices – Quality management systems. Requirements for regulatory purposes - ISO 13485 - 2016
- Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity - ISO 10993-5 - 2009
- Surgical implants. Artificial ligaments. Part...
Regulations
European Directive 90/385/EEC of June 20, 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.
European Directive 93/42/EEC of June 14, 1993 concerning medical devices.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amending Directive 2001/83/EC, Regulation...
Patents
Method, device and installation for cleaning contaminated parts, with a dense pressurized fluid WO2002032593A1
Dense fluid treatment process and apparatus with landfill storage volume EP3148717B1
Process and apparatus for supercritical fluid treatment with additive injection CA2949891A1
Process and apparatus for supercritical fluid treatment with passive...
Directory
Manufacturers – Suppliers – Distributors (non-exhaustive list)
DFD SA (Dense Fluid Degreasing) https://www.dfd-co2.com/fr/http://neel.cnrs.fr/spip.php?article1324
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