Medical devices intended for permanent implantation, as well as surgical instruments, must meet stringent cleanliness standards to minimize the risk of post-surgery complications. To ensure the viability of such devices, their surface cleanliness must be determined before they can be used in practical applications.
IMR's Chemistry department utilizes various extraction and analytical techniques to characterize both particulate debris as well as machining and cleaning residues on implants and surgical devices.
We test for Medical Device Cleanliness to the ASTM F 2459 method, which covers extraction and gravimetry.
Contaminants can come from a wide range of sources including oils from machining, detergent, and cleaning residues, smudges and streaks from manufacturing processes, as well as residues from packaging materials. These testing methods can uncover what part of the manufacturing process is compromising the cleanliness of the materials.
- Gravimetric Determination allows for the total mass of debris extracted by either Polar (DI Water) or Non-polar (solvents) solutions. If anything is found, additional techniques, such as the following methods, can be used to further characterize the material and identify possible sources.
- Total Organic Carbon (TOC) Analysis is a rapid examination of extracts for residual organic materials such as oils, cleaning agents, lubricants, etc. If nothing is found in a TOC analysis, the sample can be said to be free of such contaminants. If a TOC test is positive for a contaminant, then the sample can be sent for additional analysis to determine more specifically what the contaminant is from.
- Fourier Transform Infrared Spectroscopy (FTIR) Analysis is used to identify organic materials such as oils, cleaning agents, plastic particulates, and packaging residue extracted from sample surfaces and internal passages.
- Ion Chromatography (IC) is an analytical technique that permits the dynamic separation and detection of anions in an aqueous solution. Most anions can be reported to ppb levels. We can work with a variety of solvents, from reagent grade, to common cleaners or your proprietary blends. Residual ionics can lead to corrosion and other degradation of components.
- Scanning Electron Microscopy / Energy Dispersive X-ray Analysis (SEM/EDS) allows for high magnification examination of particulate and other debris removed during extraction procedures. Chemical analysis by EDs provides information on the elemental makeup of particles, allowing them to be traced back to their sources.
Proper precautions need to be taken when preparing samples for testing so cross-contamination doesn't occur. Testing labs should have proper protocols specified for best practices.
For information on IMR Test Labs Cleanliness and Contaminant Testing Services, click here.