Manufacturers of medical devices, you want to analyze the total hydrocarbon residues (HCT) in the framework of the ISO 19227 standard
What is a hydrocarbon?
A hydrocarbon is an organic compound (synthetic or natural) composed exclusively of carbon (C) and hydrogen (H) atoms. Produced by the distillation of petroleum, a hydrocarbon is a member of the family of persistent organic pollutants.
There are two types of hydrocarbons:
- saturated hydrocarbons: whose carbon chain is made up only of single bonds (e.g. alkanes)
- unsaturated hydrocarbons, whose carbon chain has at least one double or triple bond (e.g. alkenes)
In addition, hydrocarbons are present in many different products, including
lubricants
detergents, etc…
Why analyze your medical devices by GC-FID?
Gas chromatography with FID detector is a technique for separating a mixture of volatile and semi-volatile molecules. Thus, it is a method that allows the analysis of different compounds of a mixture and an evaluation of health risks.
Indeed, the analysis of hydrocarbons is part of the control parameters because their presence can present a certain toxicity for the man.
Moreover, the analysis of total hydrocarbon residues (TCH) allows to adapt the cleaning process. Indeed, HCT contamination can have various sources, in particular during :
- the manufacture of the medical device
- its handling,
- packaging and storage
Thus, the support of a laboratory accredited COFRAC ISO 17025 on the analysis of HCT and specialized in the analysis of medical devices is an essential asset for the evaluation of the cleanliness of your medical devices.
FILAB supports you in the analysis of total hydrocarbon residues (HCT) by GC-FID
The FILAB laboratory can assist you in the analysis of total hydrocarbon residues (HCT) on medical devices and equipment according to the ISO 19227 standard (formerly NF S94-091), using validated and documented methods.
Thus, our experts are at your disposal and offer you their analysis services for HCT cleaning residues.
To go further
Analysis of particulate contamination by Scanning Electron Microscopy (SEM)
