Medical Device Cleanliness and Cytotoxicity Testing

cytotoxicity testing on medical devices tests cleanliness of coatings and materials Medical devices that are permanently implanted inside the body require a high degree of cleanliness to minimize patient complications after surgery.  The evaluation of the level of cleanliness of these devices is a critical measure of their viability. IMR Test Labs is ready to help medical device manufacturers avoid the major risk of potential adverse reactions by the human body from contaminants on implants. 

Our modern, newly designed Cytotoxicity Lab is fully equipped to provide accurate and reliable testing and analysis of the reaction of human cells to a wide range of contaminants on implantable devices.  Our experienced analysts provide thorough evaluations that help assure you that your devices are free from hazardous contamination. 

The cytotoxicity test itself utilizes sterile human cell cultures to determine the biocompatability of finished devices.  The cells are isolated in vitro and exposed to extracts obtained from devices, resulting in a visible evaluation of toxicity potential. 

IMR Test Labs also offers a wide range of chemical analysis techniques designed to assure that manufacturing, handling, and packaging processes don’t leave oils, particulates, detergents and other contaminants behind that can compromise your product’s performance and reliability.  Our cleanliness testing experts perform testing protocols designed to get a complete and accurate picture of the contaminants involved.  We work with a variety of solvents to extract various polar and non-polar compounds from the surfaces for evaluation.

Cleanliness / Biocompatibility

Supported by our skilled chemical, metallurgical, corrosion and failure analysis departments, IMR offers both characterization and quantification of residues and particulates to help you quickly eliminate sources of contamination.

With a range of techniques from FTIR, Total Organic Carbon, Ion Chromatography, GC/MS, optical and scanning electron microscopy (SEM, SEM-EDX), IMR is equipped to test for contaminants including:
 
- Cutting Fluids
- Particulates
- Detergents/Cleaning Solutions
- Oils
- Anions/Cations
- Halogens
- Mold Release Agents
- Plasticizers