Principle of the method:
Possible Impurities containing carbon and nitrogen are extracted from the product and the corresponding elements are then reliably detected down to the sub-µg range (depending on the size of the MD). The molecules of the dissolved impurities are catalytically oxidized in a combustion tube to form CO2 or NO2 and the resulting gases are quantified spectroscopically.
Typical application:
Any impurities on the test device are first extracted by a solvent and then the solution is analyzed for organic carbon (C) and/or nitrogen (N). The extraction is performed «exhaustively», i.e. it is repeated until the measured impurity concentration in the extraction solution falls below 10% of the first extraction. The quantified amounts of each extraction are summed up to give the total amount of organic impurity. ISO 19227 specifies a limit value of max. 0.5 mgC/implant.
Figures: Possible Task: MP is soiled, cleaned, and any organic residues in the extraction solution are reliably quantified using TOC/TIC/TN.
Our offerings for medical device cleanliness testing
- Shimadzu» TOC-L Analyzer
- Determination of dissolved organic carbon (TOC)
- Determination of the dissolved inorganic carbon (TIC)
- Determination of the dissolved nitrogen (TN: total nitrogen, e.g. from proteins)
Other services
- Quantification of residual protein (BCA test)
- Quantification of trace elements by ICP-MS
- Cleanliness of surfaces by SEM/EDX and XPS
- Particle analysis by laser diffraction (LD) and light obscuration (LO)
