CLEANLINESS TESTING AND CONTAMINANT ANALYSIS
To mitigate material cleanliness issues during the manufacturing process, very precise testing techniques are required to identify the source and composition of the contaminants. One of the most common methods is gravimetric testing.
Gravimetric cleanliness testing involves:
- Washing the part so as to transfer particulate contamination from the part to the washing fluid.
- Filtering the washing fluid so as to transfer the contaminant to an analytical membrane filter of defined size.
- Weighing the change in filter mass so as to determine the contaminant mass.
- Reporting and analyzing results.
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.
Medical Device Cleanliness
Medical devices intended for permanent implantation must meet stringent cleanliness standards to minimize the risk of post-surgery complications. To ensure the viability of such devices, their medical cleanliness must be determined before they can be used in practical applications.
By utilizing our Keyence Stereoscope, we perform particle size evaluation in solid samples as well as liquids, quantifying particle totals in the micron size ranges for metallic and nonmetallic particles.
We test for Medical Cleanliness to the ASTM F 2459 method. This covers extraction and gravimetry.
CONTAMINANT ANALYSIS CAPABILITIES
Contaminants can come from a wide range of sources including oils from equipment, residues from human hands, smudges and streaks from manufacturing processes and corrosion from leaks of water, coolants and more.
- 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.
- ICP Chemical Analysis identifies elemental contaminants in extracts, such as residual iron from tooling during cutting, as well as providing a thorough breakdown of metallic particulates.
- 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.
Contact us to find out how to best collect and ship the sample to prevent cross-contamination.
ISO 10993- Part 12: Medical Device Testing
ISO 16232 - Automotive Parts / Liquids
ASTM F 2459 - Medical Devices
ASTM E 1019
ASTM E 1447
ASTM E 1409
Click here for a complete list of accreditations and certifications for all IMR Test Labs locations.