Among the many challenges of 2020 was the need to dramatically increase the production of anti-viral protective products.
To meet the newfound demand for vast quantities of hand sanitizer, the US Food and Drug Administration released new guidelines for hand sanitizer production by unregistered companies. Doing so allowed general industry to step up and meet the demand — however, the sourcing of untested raw materials and typical industry quality systems proving insufficient left open the possibility for contaminated or improperly manufactured material to enter the marketplace.
ATS was able to help companies prevent potential harm to the general public by offering both contaminant and active ingredient testing for hand sanitizers. ATS leveraged our extensive experience with consumer product testing to immediately reconfigure our Gas Chromatography-Mass Spectroscopy (GC-MS) lab to provide this new service. In fact, ATS developed internal methods for methanol contamination of hand sanitizer well before the FDA released public methodology, providing critical safety testing for our customers when no federal guidance yet existed.
ATS continues to provide this essential service, offering multiple levels of testing. The efficacy of a hand sanitizer product depends on the high concentration of its active ingredient, typically ethanol or isopropanol.
ATS tests both gel and liquid products by Gas Chromatography with Flame Ionization Detector (GC-FID) to verify that the active ingredient concentration meets FDA requirements, ensuring that the product will be effective at killing the virus that causes COVID-19. The other critical component of testing hand sanitizers is the confirmation that no harmful contaminants are present.
On August 7, 2020, the FDA released impurity limits for 12 different contaminants of concern, including methanol, benzene, and acetaldehyde. ATS provides quantitative testing of the full list of impurities through GC-MS and GC-FID testing of raw materials and finished products. In addition to these safety-critical tests, ATS can also perform both quantitative analysis of typical inactive ingredients and qualitative screening for additional impurities not listed in the FDA guidance.