Chemical Characterization
Posted by StaciH111
from the Health category at
03 Jan 2024 01:47:23 am.
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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 & LeachablesSTEMart 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.
- Degradation ProductsAccording 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 OxideAccording 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 TestingSTEMart 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.
- 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.
Tags: Characterization
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