Chemical Characterization is a powerful methodology for addressing biocompatibility endpoints, providing a risk assessment of biocompatibility using chemical, biocompatibility, and patient exposure data. Chemical Characterization involves the extraction of the device with various solvents, chemical analysis of compounds extracted from the device, and an evaluation of the toxicological risk associated with the patient exposure to the extracted compounds.
Standard for Chemical Characterization
“Chemical Characterization of materials”, part eighteen of the Biological evaluation of medical devices standards (ISO 10993-18), gives out the general considerations for the analytical approach including the intended use of device contact time (blood, mucosal, skin contact), material composition, and surface area calculations. It also outlines for the extractables, the study design, solvents, temperature, and duration should be taken into account; while for the leachables, the drug formulation, storage, and handling of drug and delivery devices should be taken into account.
STEMart offers Chemical Characterization service utilized modern analytical techniques and instrumentation, following the biocompatibility guidelines modified for medical devices and using a solid scientific rationale. The testing is designed and performed based on the route of exposure to the body including the skin, mucosal, or ocular.
Our Chemical Characterization Services
Extractables & Leachables
STEMart offers Extractable & Leachables testing service utilized modern analytical techniques and instrumentation, following the ISO 10993 standard for medical devices. Medical device manufacturers can use it to show that materials of concern do not migrate from the device into the patient.
According to ISO 10993 standard, STEMart provides comprehensive degradation product testing based on the material chemistry and end-use biological environment for polymeric, ceramic and metallic medical devices.
Residual Ethylene Oxide
According to ISO 10993 standard, STEMart offers residual ethylene oxide testing service to identify and quantify the content of ethylene oxide, ethylene chlorohydrin, and ethylene glycol in medical device with gas chromatography techniques.
Raw Material Testing
STEMart provides raw material identification and characterization services to the medical device to help manufacturer select their suppliers, avoid costly production problems and delays, and ensure consistence of their products.
Techniques for Chemical Characterization
Gas Chromatography (GC) for volatile organics
GC-Mass Spectrometry (MS) for analyte identification of solvents, plasticizers, and degradation products
High Performance Liquid Chromatography (HPLC) with MS detection for non-volatile/ semi-volatile analyte identification
Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for elemental analysis (i.e., heavy metals and other process impurities)
HPLC with laser light scattering or LC/MS can monitor the polymers/lubricants from the device or manufacturing process.
STEMart provides comprehensive chemical characterization service to help medical device manufacturer to evaluate hazards related to device and manufacture process, support process control and prove the equivalence of the proposed materials. If you have additional questions about Chemical Characterization or would like to find out more about our services, please feel free to contact us.