Specs & Testing
Introducing Our Third Party Testing Facility
To provide Quality Assurance, Perfect Mask partnered with Intertek for all testing and validation purposes. Intertek is a global network with state-of-the-art facilities and industry-leading technical expertise. Intertek provides innovative and bespoke Assurance, Testing, Inspection and Certification services to customers. For us, we chose Intertek because they provide a systemic approach to supporting our customers’ Quality Assurance efforts in each of the areas of the operations including R&D, raw materials sourcing, components suppliers, manufacturing, transportation, distribution and retail channels, and consumer management. Intertek is the industry’s leader in testing with more than 44,000 employees in 1,000 locations in over 100 countries.
The Testing Parameters
Particle Filtration Efficiency (PFE) Test
The Particle Filtration Efficiency (PFE) test evaluates the nonviable particle retention or filtration efficiency of filter media and other filtration devices at sub-micron levels. This test is performed on face masks and all filter material that allows 1 cubic foot per minute (CFM) flow to pass through it.
Also referred to as Latex Particle Challenge, this test is required for ASTM F2100 and is performed according to the ASTM F2100 and follows the basic principle of ASTM F2299.
Bacterial Filtration Efficiency (BFE) Test
The Bacterial Filtration Efficiency test determines the filtration efficiency by comparing the bacterial control counts to test article effluent counts. The test is conducted using Staphylococcus aureus as the challenge organism. After the filtration media is preconditioned, a liquid suspension of S. aureus is aerosolized and delivered to the filtration media at a constant flow rate of 28.3 liters per minute (LPM) or 1 cubic foot per minute (CFM).
The aerosol droplets are drawn through a six-stage Andersen sampler for collection. The number of bacterial aerosol droplets contacting the filter media is determined by conducting challenge controls without filter medium in the test system. Challenge controls are maintained at 1700 – 3000 colony-forming units (CFU) with a mean particle size (MPS) of 3.0 ± 0.3 µm. This allows filtration efficiencies to be reported up to >99.9%.
The BFE test offers a number of advantages over other filtration efficiency tests. It has been used with little or no modification for years and provides a standard reference for comparison of filtration materials. The mean particle size can be tightly controlled and is sized using a six-stage viable-particle Andersen sampler, permitting stage-by-stage analysis. The BFE procedure is reproducible, and provides a more severe challenge to most filtration devices than would be expected in normal use. Large numbers of material can be evaluated in a relatively short time.
BFE testing is commonly performed along with the Differential Pressure (Delta P) test.
The ISO 10993 testing is a testing performed on medical devices to determine the compatibility it has with the human body. The three main testing for biocompatibility are the following: Cytotoxicity, Irritation, and Sensitization. This helps to determine if the mask will create any irritation, or allergic reaction during use. Based on test report, it was deemed that the PMW01 Mask is safe for use in both medical and general environments.
Perfect Mask meets all requirement for ASTM F2100. Below you can find our test report verified with our third party testing facility.