The validation protocol intended to demonstrate the effectiveness of the simultaneous decontamination of 350 FFP2 masks and the maintenance of their performance was developed and deployed by salamanderU’s and Solidfog Technologies’ teams.
The protocol is in accordance with the guidance issued by the Federal Agency for Medicines and Health Products (FAMHP): “Guidance for the reprocessing of surgical masks and filtering facepiece respirators (FFP2, FFP3) during the Coronavirus disease (COVID-19) Public Health Emergency”.
The validation of a series of 10 consecutive cycles has been carried out and the chemical and biological indicators’ results meet the requirements and show that the disinfection is effective.
To complete the validation protocol, the 10 times decontaminated masks have been sent to a laboratory to test their particles’ penetration level and their fitness for use.
Results show the particles’ penetration level to be 1% (max. 6% are allowed by standard EN 149 + A1) and the fit test results are described as “very good”.
It should be noted that the relevance of our solution is reinforced by the tests approved by US FDA authorities. These studies confirm the effectiveness of disinfection with H2O2 and prove that the masks maintain their physical properties after 30 decontamination cycles.
Our “BubbleFog” solution for large-scale decontamination (350 masks per cycle) of FFP2 masks therefore offers all guarantees in terms of decontamination, particles’ penetration and fit test.
Claude Dedry (CEO) : +32 476 23 93 13 | firstname.lastname@example.org