Ansell Bioclean Sterile Mea210-3 Mask Flat Loop - 829970

Description

What it is. The Ansell BioClean MEA Sterile Looped Cleanroom Face Mask is a single-use, gamma-irradiated face mask for aseptic and critical cleanroom work. It is a flat, 3-ply mask, 210 mm wide, with polyurethane head loops that fasten behind the head with a blue plastic clip connector instead of hooking over the ears. Ansell rates the BioClean MEA sterile mask compatible with ISO Class 4 and EU GMP Grade A environments. It is part of Ansell's BioClean line of cleanroom consumables.

Sterile to a validated level. BioClean MEA sterile masks are sterilized by gamma irradiation at a minimum dose of 25 kGy, to a sterility assurance level (SAL) of 10^-6. That means the probability of a non-sterile unit is no more than one in a million, the standard expected for products used in aseptic processing. Each mask is packed with its clip in its own sealed inner bag, so it stays sterile until it is opened at the point of use.

Filtration you can document. Ansell's data sheet for the sterile MEA mask lists particle filtration efficiency above 97% at 0.3 micron, bacterial filtration efficiency above 96.5% at 3.0 microns, and viral filtration efficiency of 97.9%, with a differential pressure of 3.2 mm H2O/cm². BFE is tested to ASTM F2101. The relatively low differential pressure means the mask stays breathable over long gowned shifts, which helps operators keep it correctly positioned. Those figures come from Ansell's published product data.

Built for low particle shedding. The mask has three layers: a hygroscopic non-woven inner layer that absorbs moisture from breath, a meltblown polypropylene filtration layer, and a hydrophobic spunbonded outer layer that repels splashes. Edges are ultrasonically sealed rather than stitched, which avoids needle holes and thread that could shed particles. A fully enclosed, malleable nose band shapes the mask to the face without exposed metal. Each layer has a defined job in protecting both product and wearer.

Why head loops with a clip. Looped masks that fasten behind the head hold a steadier position than ear loops and are easier to wear under cleanroom hoods, where ear loops can be hard to reach and adjust. The blue clip connector joins the loops at the back of the head for a quick, secure fit, and it makes donning faster during gowning. The latex-free loops also avoid natural rubber latex exposure for operators and products.

Quality and shelf life. BioClean MEA sterile masks are processed in a NEBB-certified ISO Class 4 cleanroom, sampled and inspected to ISO 2859-3, and manufactured in an ISO 9001 facility. Ansell gives a shelf life of five years from manufacture when stored dry and cool, below 40 °C, away from direct sunlight and fluorescent light. Lab Pro supplies the mask for pharmaceutical, biotech, medical device, and other aseptic operations. Lot traceability supports cleanroom documentation and audits.

Technical Specifications

Applications / Common Uses

• Aseptic processing: sterile face protection in Grade A filling and compounding
• Pharmaceutical and biotech cleanrooms: low-shedding masks for ISO 4 and higher areas
• Medical device manufacturing: sterile gowning for device assembly and packaging
• 503B and compounding pharmacies: sterile masks for compounding environments
• Hooded cleanroom gowning: head loops that sit cleanly under hoods

Storage, Handling & Shipping

Store unopened masks in their original packaging in a dry, cool place below 40 °C, away from direct sunlight and fluorescent light. Open the inner bag only at the point of use and inspect it first: do not use a mask if the bag is torn, wet, or open. Masks are single-use; discard after each gowning session or if the mask becomes damp, soiled, or damaged.

• Storage: Dry, cool (<40 °C), away from sunlight and fluorescent light
• Before use: Check the sealed inner bag is intact
• Use: Single use; replace when damp, soiled, or after each gowning
• Shelf life: 5 years from manufacture

Related Categories & Services

• Masks: face masks for labs, cleanrooms, and production areas
• Cleanroom Coveralls: coveralls for full-body gowning
• Cleanroom Gloves: nitrile and other gloves rated for controlled environments
• Cleanroom Goggles: eye protection to complete the face covering
• Sterile Wipers: sterile wipers for aseptic and critical areas
• Cleanroom Manufacturing industry page: Lab Pro products used in cleanroom manufacturing
• Need recurring supply? Ask about Vendor-Managed Inventory (VMI) for standing orders of cleanroom masks and gowning supplies
• Vending Machine Solutions: on-site vending for frequently used supplies
• Punchout Catalogs: order through your procurement system

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• Lab & Cleanroom PPE Playbook
• Cleanroom PPE & Garment Selection Guide