Cleanliness Testing and Contaminant Identification Services

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:

  1. Washing the part to transfer particulate and other contamination from the part to the washing fluid.
  2. Filtering the washing fluid to transfer the contaminant to an analytical membrane filter of defined size.
  3. Weighing the change in filter mass to determine the contaminant mass.
  4. Reporting and analyzing results.
Scientist hand wearing protective gloves pouring some yellow liquid at laboratory close-up

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.

medical-device-cleanliness-hip

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.

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.

Alloy Chemistry
Antimony Analysis (ICP)
Cadmium Analysis (ICP)
Carbon, Sulfur, Hydrogen, Oxygen  & Nitrogen

Contamination ID

Contaminant/ Corrodent Analysis 
Filler/Additive Analysis
FTIR

Halogen Analysis (IC)

Heavy Metals Analysis
Hex Chrome (UV-VIS)
ICP-AES Analysis
ICP-MS Analysis
Impurities Analysis
Ion Chromatography
Material Certification
Metal Purity
OES Analysis
On-site PMI
PMI Testing (Positive Material ID)
Particle Size Analysis
Percent Crystallinity
pH

Polymer Testing
Powder Diffraction
Powdered Metal Analysis
Precious Metal Assay
Quantitative Analysis
Resistivity (ASTM D1125)
SEM-EDS
Semi-Quantitative Analysis
Trace Element Analysis
Unknown Alloy Identification
Unknown Material Identification
XRD Analysis
XRF Analysis

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

RELEVANT ACCREDITATIONS

Click here for a complete list of accreditations and certifications for all IMR Test Labs locations.