3. Implementation of the cleaning process

3.1 Schematic diagram of an installation

DFD's cleaning machines have been designed with an autoclave whose usable capacity varies according to the quantity of parts to be treated (volume of 4, 20, 30 or even 83 liters). The autoclave is horizontal, in contrast to what is used for extraction (coffee, aromatic principles, etc.), and is equipped with a shaft fitted with a watertight rotating joint, which allows an internal basket to rotate without torque limitation (technology patented by CEA Marcoule WO2002032593A1), similar to a conventional cleaning machine. In addition to this first mechanical cleaning effect, an ultrasonic device is used, with a sonotrode located inside or outside the autoclave. This device generates vibrations in the cleaning chamber, thereby removing solid contaminants...

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Implementation of the cleaning process

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page Principle of supercritical CO2 cleaning

Examples of applications on medical devices

Bibliography

(1) - SARRADE (S.), BENAISSI (K.) - Le CO ₂ supercritique et ses applications industrielles. - L'actualité chimique, 371-372, p. 72 (2013).
(2) - BENAISSI (K.) - Les fluides supercritiques à votre service....

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...