CLEANLINESS TESTING SERVICES FOR MEDICAL, TRANSPORTATION, AND AEROSPACE MANUFACTURERS
Cleanliness testing helps to mitigate 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 identification methods is gravimetric testing.
Gravimetric cleanliness testing involves:
- Washing the part to transfer particulate and other contamination from the part to the washing fluid.
- Filtering the washing fluid to transfer the contaminant to an analytical membrane filter of defined size.
- Weighing the change in filter mass to determine the contaminant mass.
- Reporting and analyzing results.
MEDICAL DEVICE CLEANLINESS TESTING SERVICES
Cleanliness testing is critical step for any medical device intended for permanent implantation, as well as devices such as surgical instruments. These products 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 medical device cleanliness team 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 standard, which covers extraction and gravimetric methods.
CONTAMINANT ANALYSIS LAB SERVICES
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.
- TOC (Total Organic Carbon) Analysis is a rapid examination of extracts for residual organic materials such as oils, cleaning agents, lubricants, etc.
- FTIR (Fourier Transform Infrared Spectroscopy) 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.
- IC (Ion Chromatography) is an analytical technique that permits the identication in an aqueous solution.
- SEM-EDS (Scanning Electron Microscopy / Energy Dispersive X-ray Analysis) 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 your samples to prevent cross-contamination. For more information, click on the button below, or click here to request a quote.
Antimony Analysis (ICP)
Cadmium Analysis (ICP)
Carbon, Sulfur, Hydrogen, Oxygen & Nitrogen
Contaminant/ Corrodent Analysis
Halogen Analysis (IC)
Heavy Metals Analysis
Hex Chrome (UV-VIS)
PMI Testing (Positive Material ID)
Particle Size Analysis
Powdered Metal Analysis
Precious Metal Assay
Resistivity (ASTM D1125)
Trace Element Analysis
Unknown Alloy Identification
Unknown Material Identification
CLEANLINESS TESTING STANDARDS
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