Your need: validate the cleaning processes of your medical devices according to the ISO 19227 standard
What is ISO 19227?
The ISO 19227 standard (formerly NF S 94-091) sets the parameters to be taken into account in the validation of the cleaning of orthopaedic implants before final packaging.
Thus, these analysis are commonly performed within a regulatory framework related to the quality assurance of medical devices.
Why validate cleaning processes according to ISO 19227?
The cleaning process plays a crucial role in the production process of medical devices. Indeed, the quality and the conformity of a device depend in particular on the level of insurance against the risks of contamination.
These contaminations can be of chemical, microbiological or particulate origin, and occur at several stages of the process.
Consequently, the cleaning operation must be validated in accordance with the requirements of standard 19227.
FILAB: a service dedicated to residue analysis as part of the validation of your cleaning processes according to ISO 19227
The FILAB laboratory offers tailor-made support to the medical industry in the validation of their cleaning processes.
Our analytical services, some of which are COFRAC ISO 17025 accredited (www.cofrac.fr), are performed according to validated and documented methods, thus helping you to bring your activities into compliance with the regulations in force.
Thanks to its state-of-the-art analytical equipment and varied internal skills, FILAB performs the following analysis
Analysis of organic contaminations by TOC meter, GCMS, LCMS
Surface analysis by SEM-FEG or Optical Microscope
Training in cleaning process validation
Search for traces in a cleaning product (detergent, oil, lubricant...)
Inorganic contamination analysis by ICP-MS and CLI
Analysis according to astm f2459
