Chemical Characterization Tests

Chemical characterization includes various analytical techniques to detect and quantify materials that have passed into solution from material in contact with the product. This testing service is often used to identify product materials, detect the presence of impurities, or create a chemical profile of an unknown formulation.

The purpose of chemical characterization testing is to establish a basis for the amount of extractable chemical compounds present in and on a medical device and to use extraction conditions similar to those used in the biocompatibility determination of similar devices.

For this purpose, many different chemical characterization techniques are used in advanced laboratories. For example,

• Gas chromatography / Mass spectrometry (GC/MS) technique. This technique is used in the analysis of extract samples for volatile organic compounds and semivolatile organic compounds.
• Liquid chromatography / Mass spectrometry (LC/MS) technique: This technique is used in the analysis of extract samples for target non-volatile organic compounds.
• Liquid chromatography (LC) technique: This technique requires the use of an ultraviolet detector to detect the presence of peaks corresponding to non-target non-volatile organic compounds.
• Inductively coupled plasma (ICP) technique: This technique is used in the analysis of extract samples for metals.

In particular, the chemical characterization tests of medical devices are based on the following standard published by the International Standards Organization (ISO): ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.

This standard establishes a framework for chemical characterization that allows the identification of biohazards and the estimation and control of biological risks from material components. This standard generally includes one or more of the following:

• Identification of construction materials (medical device configuration)
• Characterization of building materials through the identification and quantification of their chemical components
• Medical device characterization for chemicals produced during manufacture (e.g. mold release agents, process contaminants, sterilization residues)
• Determination of chemical release potential of medical device or construction materials under clinical use conditions
• Measurement of chemicals released from a medical device under clinical use conditions

Our organization also provides chemical characterization testing services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.