Description
Providing high particle and bacterial filtration efficiency, the BioClean™ MEA Cleanroom Sterile Looped Facemask is manufactured from cleanroom compatible materials to reduce contamination into the controlled environment and features loops and clip connector to allow for quick and secure fastening at back of head.
• High bacterial, viral, and particle efficiency filtration
• Fully enclosed malleable nose-band
• Ultrasonically sealed edges
• Looped with connector for secure fastening
• Manufactured in a facility holding ISO 9001:2015
• Processed in an NEBB certified ISO Class 4 cleanroom environment
• Sampling and inspection in accordance with ISO 2859-3:1994
• Tested against standard ASTM F2101 for Bacterial Filtration Efficiency (BFE)
Specifications:
• Inner Facing Layer: Non-woven polypropylene/polyethylene (hygroscopic)
• Filter layer: Meltblown polypropylene
• Outer Facing Layer: Non-woven polypropylene/polyethylene (hydrophobic)
• Fastenings: Non-latex polyurethane loops with blue plastic clip fastener
• Nose-Band: Plastic coated steel
• Color: White
• Style: Headloops
• Length (+/-5 mm): 210 mm
• Width: (+/-5 mm): 95 mm
• Sterilization: Gamma irradiation
• Minimum Dose: 25 kGy
• Sterility Assurance Level: 10-6
• Compatibility: ISO Class 4 and EU GMP Grade A
• Particle filtration efficiency (PFE) @ 0.5 micron: >97%
• Bacterial filtration efficiency (BFE) @ 3.0 micron: >96.5%
• Viral filtration efficiency (VFE): 97.9%
• Differential pressure (P), mm H20/cm2: 3.2
• Packaging: One piece (with blue clip) per sealed inner PE bag; 50 inner bags per sealed outer PE bag; 12 outer bags per lined carton (600 pieces)
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