Cleaning a medical device is an essential step before packaging; therefore, ensuring the compliance of the methods being used is a priority in the manufacturing process. ISO 19227:2018 specifies the requirements for the cleanliness of medical devices and the test methods used to validate the cleaning process. The standard applies to both intermediate and final cleaning – the objective being to verify the effectiveness of the cleaning process in reducing organic, inorganic and particulate contaminants below a defined threshold. FILAB is ISO 17025 accredited by COFRAC* for these analyses and supports manufacturers in this process.
*Certification Authority / Scopes available on cofrac.fr / Accreditation number 1-1793
Once the implant has been washed, it is important to check that the cleaning processes used are free of organic contaminants. For this analysis, FILAB uses different techniques depending on whether hydrocarbons or detergents were used :
THC (Total Hydrocarbons) analysis by GC-FID
TOC (Total Organic Carbons) analysis by TOC meter
Similarly, it is mandatory to check for inorganic contaminants depending on the type of residues that could be generated by the cleaning procedure. Therefore, FILAB performs :
Analysis of acidic mineral residues by IC
Analysis of elemental impurities by ICP
Finally, to detect any particulate contaminants using high-resolution images of the surface of a sample, FILAB uses leading edge MO (Optical Microscopy) and SEM (Scanning Electron Microscopy) techniques as well as the following legal protocols :
FILAB is the first French laboratory to have been accredited by COFRAC ISO 17025 for Medical Devices according to the ISO 19227 standard (NF S94-091).
Our 2100m² analytical fleet allows us to offer you a complete range of services. All our services in chemical analysis and material characterization are performed internally.
Our offers can be adapted to suit your needs. Our team of experts is at your disposal to adapt our techniques to the specifics of your MDs. Our prices can therefore remain competitive.
Do you have a question or would you like a quote? Don't hesitate to contact us. We'll get back to you as soon as possible.
