STEMart launches chemical characterization services for the medical device industry.
New York, United States – December 31, 2021 – STEMart, an integrated medical device CRO service provider dedicated to clinical medical device development and diagnostics, is now launching chemical characterization services for the medical device industry. The tests are designed and performed based on the body’s route of exposure, including the skin, mucous membranes or eyes.
Chemical characterization is a powerful methodology for dealing with biocompatibility parameters, providing an assessment of biocompatibility risks using chemical, biocompatibility and patient exposure data. Chemical characterization includes the use of various solvent extraction equipment, chemical analysis of compounds extracted from the equipment, and assessment of toxicological risks associated with patient exposure to the extracted compounds.
STEMart now offers a suite of chemical characterization services using modern analytical techniques and instruments, following modified biocompatibility guidelines for medical devices, and using strong scientific rationale. The tests are designed and performed based on the body’s route of exposure, including the skin, mucous membranes or eyes. There are various chemical characterization services ready for medical devices, such as extractables and leachables testing service, degradation products testing, residual ethylene oxide testing service, and acid testing service. raw materials.
Specifically, the extractables and leachables test service used modern analytical techniques and instruments in accordance with the ISO 10993 standard for medical devices. Manufacturers of medical devices can use it to show that materials of concern are not migrating from the device to the patient. STEMart also provides comprehensive degradation product testing based on material chemistry and end-use biological environment for polymeric, ceramic and metallic medical devices in accordance with ISO 10993.
In addition, STEMart offers a residual ethylene oxide testing service to identify and quantify the content of ethylene oxide, ethylene chlorohydrin and ethylene glycol in medical devices with gas chromatography techniques. Raw material identification and characterization services are also provided to the medical device to help the manufacturer select their suppliers, avoid costly production problems and delays, and ensure product consistency.
STEMart provides comprehensive chemical characterization services to help medical device manufacturer to assess the risks associated with the device and the manufacturing process, support process control and prove the equivalence of the materials offered. Various techniques are used for chemical characterizations, such as gas chromatography (GC) for volatile organic compounds, high performance liquid chromatography (HPLC) with MS detection for the identification of non-volatile / semi-volatile analytes and the Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for elemental analysis (i.e. heavy metals and other process impurities).
If you have additional questions about the medical device chemical characterization services or would like to learn more about the medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading e-commerce platform with an extensive global footprint and a large portfolio of over 10,000 products. It aims to provide the best laboratory materials, medical instruments and consumables, excellent technologies and high quality services to global customers in science, technology and engineering, discovery phase to the manufacturing process. STEMart is dedicated to making biotechnology research and production simpler and safer, and thereby accelerating access to better health for people around the world.