Biobased, biodegradable, and environmentally friendly materials have shown potential to substitute fossil fuel-based polymers in production of professional grade face masks. Although there is a good chance to alleviate the stress on the environment, the biobased medical face masks need to fulfill the same approval procedures as the current synthetic products. At the same time, the manufacturer needs to be aware of quality characteristics that may relate to the biobased origin.

The aim of the study is to establish a concept for a “chain of quality” for biobased facemask manufacturing that covers the steps from in-house checks to product approval and the use and dispose of the product.

The proposed quality control concept includes checks for raw material, nonwoven, prototype, product, shelf life, use, and disposal/recycling (Table 1). The quality checks are grouped in three categories: primary and secondary checks and product approval tests. Primary checks are conducted mainly in-house by the manufacturer utilizing quick standard or alternative tests. More detailed secondary checks are conducted mainly by a 3rd party with applicable resources such as microbiology laboratory. Product approval tests are conducted by an accredited test laboratory utilizing appropriate standards like EN 14683, ASTM F2100 or YY 0469-2011 depending on the target market.

The focus of the concept is on key technical parameters that affect the manufacturability and performance of the product. Criterion for manufacturability includes processability, mechanical strength, chemical properties, and market availability. Concerning product performance, the focus is on quick, reliable, and comparable evaluation of the main parameters for protection, that is, filtration efficiency and breathability, starting from early material and prototype development phases. The key hardware is a filtration efficiency measurement system for flat sheet materials that has been successfully adopted for rapid alternative measurements of face masks and mask materials. With this approach the R&D cycle of a mask can be speeded up and a deeper understanding of features affecting filtration performance studied in a lean manner.

Various bio-based materials are available for use in medical face mask production. After careful evaluation of different options, the quality concept is demonstrated with nonwoven materials and mask prototypes made of polylactic acid (PLA) polymer.