Chemical Characterization

MEDICAL DEVICE CHEMICAL CHARACTERIZATION SERVICES

Chemical characterization of materials is part of the overall biological safety of a medical device that can be applied in the identification of materials or the qualitative and quantitative analysis of chemicals contained in finished medical devices.
Through chemical characterization, some tests may be exempt from biocompatibility tests, such as mutagenicity, subchronic systemic toxicity, chronic toxicity, long-term implantation.

Chemical characterization processes of medical device materials;
• Determination of medical device production materials
• Characterization of production materials through qualitative and quantitative chemical composition
• Characterization of production materials arising during the production process. Medical device characterization for chemical substances (Excipients used in production, process contaminants, sterilization residues)
• Estimation of the probability of release of chemical substances from medical devices or production materials under clinical use conditions
• Estimation of the release of chemical substances from medical devices or production materials under clinical use conditions. determination of chemical substances

AVAILABLE METHODS
• Comprehensive Extraction
• FTIR test for Non-Volatile Residues or Extracts
• GC-MS test for Volatile and Semi-Volatile Organic Extracts
• ICP-MS test for Inorganic and Heavy Metal Extracts
• LC-MS test for Non-Volatile Organic Extracts
• UV-Vis spectrophotometry to evaluate colorant
• Viscosity, pH

Testing Standards
With a wide range of equipment, our Nanolab Laboratories group of highly trained chemists offer our customers the opportunity to leverage our extensive analytical resources and expertise to develop customized testing programs with a risk-based approach for the chemical characterization of their products and materials. .

ISO 10993;
• Chapter 1: Assessment and testing in the risk management process
• Chapter 7: Ethylene oxide sterilization residues
• Chapter 9: Framework for identification and quantification of potential degradation products
• Chapter 12: Sample preparation and reference materials
• Chapter 13: Identification and quantification of degradation products from polymeric medical devices
• Chapter 14: Identification and quantification of degradation products from ceramics
• Chapter 15: Identification and quantification of degradation products from metals and alloys identification and quantification of materials
• Chapter 17: Determination of permissible limits for leakable substances
• Chapter 18: Chemical characterization of materials
• Chapter 19: Physico-chemical, morphological and topographic characterization of materials

EXTRACTABLES & LEACHABLES TESTING
• Risk Assessment
Review all materials contained in the instrument and scope.
• Detection of Extractable Substances
Removing potentially leachable compounds Use appropriate solvents for.
• Toxicological Risk
Determine toxicology risk to the patient with extractable and leachable tests.
• Leachable Devices
Quantify harmful leachables in the final product to determine actual risk.
• Reporting
Provide detailed best results report to help customers comply with standards.