Over the past several years NAMSA has made significant investments to our chemistry and analytical services area as part of our ongoing commitment to get your products to market faster. We are pleased to announce the addition of several pieces of new equipment in both our Irvine and Northwood locations. These additions come on the heels of a recent renovation to the Northwood facility and the addition of ICH stability chambers to our Irvine location. This new equipment is valuable not only in method development and validation, but also for materials characterization and to establish routine analysis of medical devices for quality control.
Gas Chromatography-Mass Spectroscopy (GC/MS) Volatiles
Used to identify and quantitate volatile components, the Gas Chromatography/Mass Spectroscopy (GC/MS) Headspace unit will allow the detection of Volatile Organic Compounds from the manufacturing process and other low boiling point additives that may be present in the device.
Ultra Performance Liquid Chromatography- Quadrupole Time-of-Flight (UPLC-QTof)
While NAMSA has offered High Performance Liquid Chromatography/Mass Spectroscopy (HPLC/MS) for many years, we have recently upgraded to an Ultra Performance Liquid Chromatography-Quadrupole Time-of-Flight (UPLC-QTof). This allows better interpretation of unknown extractable components, providing more accurate mass information and functional group identification.
High Performance Liquid Chromatography-Ion Chromatography (HPLC-IC)
Another addition to our liquid chromatography capabilities, ion chromatography, allows for the separation of polar molecules based on their ionic charge. Anions and cations can commonly be found in medical devices as residuals from the cleaning process, from catalysts, or other additives. This technique provides a means to isolate and identify these potential extractables.
Inductively Coupled Plasma- Mass Spectroscopy (ICP-MS)
Reducing detection limits and expanding the list of elements available are two reasons NAMSA has upgraded from our current Inductively Coupled Plasma (ICP) / Optical Emission Spectroscopy. We have also added microwave digestion capabilities to better allow us to process samples for total metal content.
To enhance NAMSA’s particulate testing, we have added microscopic capabilities to our FTIR in Irvine. This allows us to provide identification of organic particles, to better isolate the origin of these materials in medical devices. This technology can also be used to identify contamination in devices.
To learn more about how these technologies can help with your R&D studies, commercial products, combination devices and medical device packaging needs, please reach out to us at namsa.com/contact-us.