Bruker MicroCT Systems Supporting Quality Control for Refurbished FFP Masks
Bruker MicroCT Systems Supporting Quality Control for Refurbished FFP Masks
As companies and organizations across the world look for ways in which they can play their part, either alone or as part of a collaboration, in the effort to tackle the coronavirus pandemic, Bruker is extremely proud that its instruments are being used to ensure quality levels of reprocessed filtering face pieces (FFP) commonly known as facemasks.
The current coronavirus crisis is placing a great strain on the procurement of personal protective equipment (PPE). To keep pace with the demand for FFP2 and FFP3 facemasks, Helios, a private hospital group that operates hospitals throughout Germany, wanted to find a way to refurbish these single-use masks to ensure that frontline medical and nursing workers who have direct contact with patients have a continuous supply of protection when facing supply shortages.
FFP2 and FFP3 masks offer highly effective protection. The filter fabric comprises several layers, including a membrane - the filter 'fleece' - that prevents virus particles passing through. With previous tests demonstrating that refurbishing single-use masks did not meet satisfactory safety levels, Helios was determined to develop a more thorough procedure.
Refurbishment of face masks is currently causing controversy. The EU standard for testing masks uses paraffin vapor to create 0.3 micron droplets. In the US, stricter controls enforce smaller droplet size. The Helios testing procedure uses the stricter test with nanoparticles of smaller size than the coronavirus.
Through extensive studies, Helios confirmed that many reprocessing methods fail to deliver a quality final product. For example, although using steam sterilization produces a sterile product, the heat in any method above 75 degrees Celsius destroys the mask's protective membrane, rendering it useless.
Experts at Helios finally landed upon a multi-stage process that uses dry heat to produce refurbished masks that conform to a higher safety standard than that initially stipulated and recently withdrawn by the Robert Koch Institute (RKI).
Rigorous quality checks form part of the process to test the structural integrity of the masks, both prior to and after the refurbishment had been established. These quality control tests were conducted via RJL Micro & Analytical (RJL), a specialist company who also provides research and analytical services in its ISO-certified laboratory. By using Bruker's micro-CT systems to perform extensive structural examinations via X-ray microtomography, RJL can demonstrate the structural integrity of the masks. Particle retention tests confirmed the membrane integrity further and, therefore, vouch for the new method's viability.
Although purchasing new masks is equally as cost-effective as this refurbishing process, when large-scale demand outstrips supply, the new method will help to alleviate the pressure. Being a part of this success story is particularly satisfying because it's not just Helios staff who stand to benefit, or even medical staff in Germany; by freely publishing this method online, Helios is helping to protect frontline workers worldwide while Bruker is proud to supply the analytical tools for reliable quality controls.