Chemistry

Chemistry is the study of matter and how substances combine and/or interact to form other substances.

Chemistry, like many sciences, is a broad field that encompasses many professionals, including microbiologists, chemists, and chemical engineers. Furthermore, the chemistry of a medical device or material that enters a patient impacts both the user of the device or material and the patient (e.g., tattoo artists, physician). Moreover, the material suppliers for these materials are involved in the ensure the safety and lack of contamination.  

 

This discipline includes fundamental research on the compatibility between products and the immune response of the human body (toxicology). Included within chemistry are subjects such as biochemistry, physiology, neurobiology, and pharmacokinetics. By understanding the fundamental atomic relationships that govern chemical degradation, one can better asses the safety and efficacy of a medical device. 

 

Chemical characterization takes place in laboratories and in the process of product design and manufacturing.  

 

This testing includes a variety of techniques, which use isolation, purification, and structural elucidation of a product or material to analyze their chemical properties. Some examples of this testing include: 

 

Extraction (2) 

  • Exhaustive (extractable testing) vs. simulated use (leachable testing) 

  • Extractable testing is used to test product (and sometimes medical device) components that do not contact a patient. Therefore, harsh solvent, time, and temperature are used to isolate and test all material characteristics (most common for general products). 

  • Leachable testing: use of clinically relevant solvent, time, and temperature to test in-patient safety (most common for medical devices). Clinical relevance pertains to the environment in which medical devices are exposed when used by physician. 

Isolation 

  • Flask chromatography 

  • Preparatory high performance liquid chromatography (HPLC) 

                               HPLC 

High-performance Liquid Chromatograph Ma

Purification 

  • Chromatography (e.g., Headspace gas chromatography) 

  • Solid Phase Extraction (SPE) 

Structural Elucidation 

  • 1H and 13C NMR 

  • Fourier-transform infrared spectroscopy (FTIR) 

  • Mass Spectrometry (MS) 

  • Gas chromatography mass spectrometry (GCMS) 

  • Inductively coupled plasma mass spectrometry (ICPMS) 

  • Liquid chromatography mass spectrometry (LCMS)  

Spectroscopy .jpeg

For a more detailed explanation of these techniques please feel free to contact us as 1-763-639-7111 or, by email, at info@microbioconsulting.com

 

MicroBio uses biocompatibility evaluations to determine the necessity of chemical characterization for medical devices under ISO10993:18-2020. This testing is required to ensure that the medical devices do not cause adverse immune responses when used by physicians. Further, MicroBio strives to work with material suppliers to ensure materials can be safely used in newly developed products. 

Resources referenced:

  1. Braun, R. Denton (2016, April 1). Chemical analysis. Encyclopedia Britannica. https://www.britannica.com/science/chemical-analysis 

  2. ISO10993-18:2020