Cleaning of Medical Devices

Pierre Fabre’s supercritical (SC) fluids unit proposes its services to clean medical components by SC CO₂.

Using SC CO² is an innovative and efficient way to clean and de-grease medical devices and textiles. Its properties are particularly well adapted to de-grease medical components without toxic chemical solvent. There is no drying step and no solvent residue after extraction, and the mechanical properties of components treated by SC CO₂ are preserved.

Key features include:

• Removal of extractables and leachables
• Scouring of textile
• Reduction of bioburden

Compliant with guidance on HVAC system

The Pierre Fabre Supercritical Fluids Division works in compliance with GMP (good manufacturing practices) and highest ISO standards.

Key features include:

• Personal and material airlock
• Qualification of equipment
• ISO 7 cleanroom with air handling control (particles, bacteria)

At the stage of commercial production, the components to clean enter the SC fluids workshop and are treated by an SC CO₂ process in reactors of between 2l and 50l, in an ISO 7 cleanroom. After the cleaning, the components are ready to go on to further process steps in customer installations, including assembly, sterilisation and packaging.

CO₂ is also a green solvent to allow the impregnation of API in Medical Device.