Cleanroom

Construction:

3 ply - Ultrasonic sealing.

NON-STERILE:
Outer facing: Hydrophobic Polypropylene/PE (Non Woven).
Filter layer: Meltblown Polypropylene.
Inner facing: Hydrophilic Polypropylene/PE (Non Woven).
Earloops: Polyurethane.

STERILE:
Outer facing: Hydrophobic Polyester.
Filter layer: Meltblown Polyester.
Inner facing: Hydrophilic Polypropylene/PE.
Earloops: Polyurethane.

Protein Level:

No latex proteins.

Sterilisation Method:

Where applicable - Gamma Irradiation

Physical Properties:

NON-STERILE
Particle filtration efficiency (PFE): >98%
Bacterial filtration efficiency (BFE): >97%
Pressure drop (Delta P): 2.7

STERILE
Particle filtration efficiency (PFE): >96%
Bacterial filtration efficiency (BFE): >94%
Pressure drop (Delta P): 3.2

Packing:

Bagged

Particle Shedding Analysis:

Average Particle Count = 19/minute (Particle size: 0.2 - 5.0 microns). Test method: ASTM F51-68 (1989).

Quality Systems:

Produced in a facility registered to ISO 9001:2000 and ISO 13485:2003.

Sampling & Inspection:

In accordance with ISO 2859 standard procedures.

Storage Instructions:

Store in dry, cool place (<40°C) away from direct sunlight and fluorescent light.

Shelf Life:

Five (5) years from date of manufacture.

Lot Number:

This appears on all the bags and the outer carton to provide traceability.

Packaging:

MEA 210-0 - Non-Sterile - Bulk packed
100 pieces per sealed inner bag;
1 inner bag per sealed outer bag;
20 outer bags per carton (2000 pieces).

MEA 210-1 - Sterile and MEA 210 Non-Sterile* - individually packed with clips
1 piece per sealed pouch;
50 poches per sealed outer bag;
12 outer bags per carton (600 pieces)

Notes:

* MEA 210-2 are available subject to special order.

Compatibility:

ISO Class 4.

Product Codes
and Sizes:

MEA 210-0: Non-sterile Bulk
MEA 210-1: Sterile Single with clips
MEA 210-2: Non-sterile Single with clips