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Bioclean MEA Sterile Looped Facemask

Bioclean MEA Sterile Looped Facemask

Product catalog summary

Product Overview: The BioClean MEA™ Sterile Looped Facemask offers high particle and bacterial filtration efficiency, ensuring protection with comfort and breathability. It is latex-free and low-linting, suitable for cleanroom environments.

Materials: The facemask consists of a hydrophilic inner layer made of non-woven polypropylene/polyethylene, a meltblown polyester filter layer, and a hydrophobic outer layer of non-woven spunbonded polyester. It features non-latex polyurethane loops with a blue plastic clip fastener and a plastic-coated steel nose-band.

Features: Key features include ultra-low particulation, high strength seams, 3-ply ultrasonic sealing, high bacterial and particle filtration efficiency (BFE & PFE), and compatibility with ISO Class 4 and EU GMP Grade A standards. The mask provides excellent breathability and low-linting properties.

Quality Standards: The facemask is manufactured in an ISO 9001:2008 certified facility and processed in an NEBB certified ISO Class 4 cleanroom. It is tested for BFE according to ASTM F2101 standards.

Sterilization: The mask is sterilized using gamma irradiation with a minimum dose of 25kGy, achieving a sterility assurance level of 10⁻⁶.

Shelf Life: The product has a shelf life of five years from the date of manufacture.

Contact Information: Headquarters are located in Newmarket, Suffolk, UK. Contact details for Europe, Asia, and the Americas are provided for ordering and inquiries.

Ordering and Packaging: The re-order code is MEA 210-1. Each mask is individually packed in a sealed inner PE bag, with 50 inner bags per outer PE bag, and 12 outer bags per carton, totaling 600 pieces.

Physical Properties: The mask is white, looped, with dimensions of 210mm in length and 95mm in width.

Performance Information: The mask is compatible with ISO Class 4 & EU GMP Grade A environments, with a particle filtration efficiency (PFE) of >97% at 0.3 microns, bacterial filtration efficiency (BFE) of >96.5% at 3.0 microns, viral filtration efficiency (VFE) of 97.9%, and a differential pressure (ΔP) of 3.2 mm H20/cm².

Catalog excerpts

N^^. pure ■ product • protection Providing high particle and bacterial filtration efficiency, the latex-free and low- linting BioClean MEA™ Sterile Looped Facemask ensures protection, combined with comfort and exceptional Sterile Looped Facemask EXCELLENT BREATHABILITY INNER FACING LAYER: Non-woven polypropylene/polyethylene FILTER LAYER: Meltblown polyester OUTER FACING LAYER: Non-woven spunbonded polyester Non-latex polyurethane loops with blue plastic clip fastener Plastic coated steel • Ultra-low particulation • High strength seams • Loops with blue plastic clip connector to allow secure fastening at back of head HYDROPHOBIC OUTER LAYER HYDROPHILIC INNER LAYER Mr. & Mrs Phil Trayshon™ represent ^^BioClean's range of GMP compatible

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Quality Standards Manufactured in a facility holding ISO 9001:2008 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) Method: Gamma irradiation Minimum Dose: 25kGy Sterility Assurance Level: 10⁻⁶ Shelf Life Five (5) years from date of manufacture Physical Properties COLOUR Performance Information COMPATIBILITY PARTICLE FILTRATION EFFICIENCY (PFE)@ 0.3 MICRON BACTERIAL FILTRATION EFFICIENCY (BFE) @ 3.0 MICRON VIRAL FILTRATION EFFICIENCY (VFE) Re-order...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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