One of the cornerstones of a biological evaluation process is chemical characterization. Chemical characterization testing is crucial for the development of new medical devices and assessment of changes to existing medical devices. Chemical characterization can be performed either through testing or through comprehensive existing knowledge of materials of construction and processing of a device. The chemical characterization process is intended to facilitate an evaluation of potential systemic toxicity risks which may be posed through clinical use of the device.
If testing is performed to provide chemical characterization data, the study design needs to consider and appropriately simulate or exaggerate the duration and nature of body contact during clinical use of the device. Chemical characterization testing should evaluate whether the chemical risks change as a function of exposure time and whether particular environments may also encourage the release of particular chemical species or degradation of a material.
An experienced chemical testing partner such as Jordi Labs can help you evaluate the risks certain materials pose as part of a comprehensive biological evaluation plan.
Chemical Characterization Testing
Chemical characterization testing involves screening for extractables and leachables that may be released from a material during clinical use. With their extensive expertise in cutting-edge analytical methods, Jordi Labs has the full laboratory facilities to perform comprehensive chemical characterization testing for a range of chemicals that may be found as extractables and leachables.
One of the key aspects of a properly designed extractables/leachables study for a medical device is adequate representation of interactions between the device and relevant physiological tissues over its intended clinical use duration. Given that many device types are used over an extended period, and have contact with physiological tissues which are not readily analyzable with appropriate levels of sensitivity, chemical characterization studies need to be designed to simulate these physiological tissues and exposure durations in an analytically amenable manner.
Jordi Labs can help you perform extractables and leachables testing in alignment with ISO 10993-18:2020, to yield a comprehensive chemical profile for characterization or toxicological risk assessment purposes. Jordi Labs can help you design appropriate chemical characterization studies, and produce reports designed to meet these the expectations of regulatory agencies.
For chemical characterization testing, it is important to use highly sensitive analytical methods and robust identification capabilities, to ensure that toxicologically relevant compounds can be detected, identified, and quantified. This is particularly important considering evolving regulatory expectations regarding the analytical evaluation threshold (AET) and confidence level of organic compound identification.
Jordi Labs can help profile chemical species present as extractables and leachables using techniques such as gas-chromatography mass spectrometry (GC-MS), liquid chromatography mass spectrometry with ultraviolet-visible and charged aerosol detection (LC-MS-UV-CAD), and inductively coupled plasma mass spectrometry (ICP-MS). These analytical methods can provide both qualitative and quantitative analysis of any chemical species and offer excellent sensitivity. Jordi Labs has a continually expanding LCMS database of over 5000 unique medical device relevant compounds, and uses the NIST/EPA/NIH spectral library and Wiley Registry of Mass Spectral Data of over 795,000 compounds for GCMS analysis, and performs extensive review using manual and proprietary software processes to ensure identification quality. Jordi Labs also offers numerous specialty analytical techniques to solve challenging chemical characterization problems.
Contact Jordi Labs today to find out how we can support your chemical characterization testing needs and help you plan the most cost-effective and efficient way to develop your medical devices.
Jordi Labs offers consulting and testing services for raw materials through to final device testing and a comprehensive range of standard testing methods to accelerate your chemical characterization testing.