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Certifications

Our tests have been completed by FDA registered and ISO 17025 accredited Nelson Labs, the leading global provider of microbiological laboratory testing for MedTech and pharmaceutical companies.

Particle Filtration Efficiency (PFE)

Our filter media has been tested against a particle size of 0.1μm (microns) and received an average filtration efficiency of 99.50%.

Click to download file: Nelson Labs PFE Report

Viral Filtration Efficiency (VFE)

Our filter media has been tested in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820. The filter media received a viral filtration efficiency of 99.99%.

Click to download file: Nelson Labs VFE Report

Bacterial Filtration Efficiency (BFE)

Our filter media has been tested in compliance with ASTM F2101-19 and EN 14683:2019, Annex B. The filter media received a bacterial filtration efficiency greater than 99.80%.

Click to download file: Nelson Labs BFE Report

Below are the test results for the copper-infused antimicrobial material which has been used to make the carry bag. This material has been independently tested to ensure it meets a high standard of antimicrobial performance.

Staphylococcus aureus (ATCC 6538) >99%

Escherichia coli (ATCC 25922) >99%

Candida albicans (ATCC 10231) 98%

STS is a leading independent testing agency and is accredited ISO17020:2012, the highest qualification level of inspection bodies.

Click to download file: STS Copper Infused Anti-Microbial Bag Report