Our American distributors received policy guidance from the U.S. Food and Drug Administration (FDA)

AMB Ecosteryl introduces the “M-steryl machine” which is capable of decontaminating up to 2,100 N95 Masks or 144 gowns within a 24-hour cycle. This decontamination system aids Healthcare and other industries in overcoming and alleviating the issue of N95 mask shortages as well as providing a great opportunity to save money while also reducing waste.

Tampa-based TMPC Inc., in partnership with Tex Med Consulting of San Antonio received policy guidance from the U.S. Food and Drug Administration (FDA) for Dry Heat Bioburden Reduction Systems for N95 Respirators.

The Ecosteryl dry heat decontamination system – “M-steryl” – for N95 respirators is designed to decontaminate used N95 masks and respirators in order to prevent exposure to aerosolized infectious particles. This is especially critical when supplies of N95 respirators are at a premium during this COVID-19 pandemic.

Through the convenience of on-site sterilization of used masks using a tabletop M-Steryl device, healthcare professionals or anyone within a facility which is dependent on N95 respirators can be assured that they are attaining a coronavirus kill rate of 6 Log10 or greater while maintaining mask performance and function.

Published reports and peer-reviewed literature have demonstrated that dry heat processing is the preferred method for assuring both viral inactivation and N95 respirator performance to achieve the optimum number of reuses which currently, per FDA guidelines, is no more than 5 uses (one initial use and 4 reuses). The Ecosteryl team has carried out tests to decontaminate devices 3 times, so we recommend a total of 4 uses per mask.

“AMB Ecosteryl has leveraged their deep scientific capability to fight this pandemic and chose Tex Med Consulting to be their Exclusive US Distributor” said William Jewett, CEO of Tex Med. “Tex Med is proud of our efforts to combat COVID-19” Jewett added.

“This device can decontaminate rapidly masks but also gowns” said Joe Teasley, CEO of TMPC Inc. “The cost savings, simple use, and the capability to decontaminate the masks at your location gives back the control your team needs to combat the Covd-19 pandemic” he added.

All information for the US market can be found here:  https://tmpcinc.com/product/m-steryl/