Testing of PPE and Hand Sanitizers
BioScreen/ALS provides routie analysis and pre-market testing for masks, hand sanitizers, and antiseptic washes. The
results can be used for premarket testing, emergency declaration compliance, 510k submissions, and CE marks.
For Hand Sanitizers
Analyical Analysis
Analyitcal analysis is offered both for the quantification of ethanol and the absence of methanol. Both of these are required to meet FDA requirements, the presence of methanol is routinely seeing product pulled from the market place by regulators.
Microbiological Analysis - Time Kill/Log Reduction
For hand sanitizers (antiseptic rubs per FDA monograph) and anti-microbial soaps (antiseptic washes per FDA monoraph) offers log reduction testing to ensure the effectiveness of antimicrobial properties of these products. Log reduction testing can be performed either per ASTM E1054 on 24 organisms in accordance with the FDA final monograph, or using BioScreen's in house methods on a selection of organisms of the client's choosing.
MIC and MBC are also available for these products in accorance with FDA requirements.
Mask Testing
Through our network of affiliate laboratories BioScreen-ALS is pleased to offer premarket testing of protective masks. Below is the list of tests BioScreen is currently able to offer at competitive cost and turn around times.
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Surgical Masks
» Differential Pressure Assay per UNE-EN 14683 or ASTM 2100-9
» Bacterial Filtration efficiency per UNE-EN 14683 (for EU) or ASTM F2100-19 for USA
» Synthetic Blood Penetration per UNE-EN ISO 22606 or ASTM F18A positive result indicates the presence
» Microbial Cleanliness per ISO 11737-1
» Latex Particle Challenge per ASTM F2299 - NOT CURRENTLY OFFERED (Setup Pending) -
Hygenic Masks
» Bacterial Filtration efficiency per UNE-EN 14683 (for EU) or ASTM F2100-19 for USA
» Differential Pressure Assay per UNE-EN 14683 or ASTM 2100-9
» Washing per Manufacturer's protocol or UNE EN ISO 6330 -
EPI Masks
» Penetration of Filter material CINa per EN 149:2001
» Total inward leak per EN 149:2001
» Breathing Resistance per EN 149:2001