STEMart Introduces Chemical Characterization for Medical Device Industry
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches chemical characterization services for the medical device industry. The testing is designed and performed based on the route of exposure to the body including the skin, mucosal, or ocular.
Chemical characterization is a powerful methodology to address biocompatibility endpoints, providing a risk assessment of biocompatibility using chemical, biocompatibility, and patient exposure data. Chemical characterization includes the use of various solvent extraction equipment, chemical analysis of the compounds extracted from the equipment, and assessment of the toxicological risks associated with patient exposure to the extracted compounds.
STEMart now offers a series of chemical characterization services 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. There are various chemical characterization services ready for medical devices, such as extractable & leachables testing service, degradation product testing, residual ethylene oxide testing service, and raw material testing service.
Specifically, Extractable & Leachables testing service has 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. STEMart also provides comprehensive degradation product testing based on the material chemistry and end-use biological environment for polymeric, ceramic and metallic medical devices according to ISO 10993 standard.In addition, 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 identification and characterization services are also provided to the medical device to help manufacturer select their suppliers, avoid costly production problems and delays, and ensure consistence of their products.
STEMart provides comprehensive chemical characterization services 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. Various techniques are used for chemical characterizations, such as Gas Chromatography (GC) for volatile organics, High Performance Liquid Chromatography (HPLC) with MS detection for non-volatile/ semi-volatile analyte identification, and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for elemental analysis (i.e., heavy metals and other process impurities).
If you have additional questions about medical device chemical characterization services or if you would like to find out more about the medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading eCommerce platform with an expanded global footprint and has a broad portfolio of more than 10,000 products. It aims to provide best-in-class lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage towards the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer, and through that to accelerate access to better health for people everywhere.