一. Material preparation
FFP2 masks are typically composed of the following materials:
Outer non-woven fabric: waterproof layer, blocking large particles and liquids.
Meltblown fabric: The core filter layer filters out small particles such as viruses and bacteria.
Inner non-woven fabric: a skin friendly layer that absorbs moisture and respiratory vapor from the wearer.
Nose clip: A metal or plastic strip that ensures a tight fit between the mask and the nose bridge.
Ear or headband: elastic material used to secure masks.
二. Production process
(1) Material cutting
Cut non-woven fabric and meltblown fabric according to the design size to ensure that the size of each layer of material is consistent.
(2) Laminated composite
The outer non-woven fabric, meltblown fabric, and inner non-woven fabric are bonded together by hot pressing or ultrasonic welding to form the main body of the mask.
(3) Forming
Use a molding machine to press the composite material into the three-dimensional shape of a mask (usually cup-shaped or folded).
(4) Nose clip installation
Insert nose clips at the upper edge of the mask to ensure it is secure and easy to shape.
(5) Ear strap/headband welding
Fix the ear or headband on both sides of the mask by ultrasonic welding or hot pressing.
(6) Sterilization treatment
Sterilize the mask (such as ethylene oxide sterilization or irradiation sterilization) to ensure its sterility.
(7) Quality inspection
Strictly inspect the quality of masks, including:
Filtration efficiency test: Ensure that the filtration efficiency is ≥ 94% (FFP2 standard).
Tightness test: Ensure that the mask is tightly attached to the face.
Respiratory resistance test: Ensure smooth breathing for the wearer.
Microbial testing: Ensure sterility.
(8) Packaging
Packaging qualified masks, usually in individually sealed packaging, to avoid contamination.
三.Certification and Standards
European standards: EN 149:2001 + A1:2009
FFP2 masks need to pass CE certification and comply with the EU Personal Protective Equipment (PPE) regulations.
Other standards: The production process must comply with standards such as ISO 9001 (Quality Management System) and ISO 13485 (Medical Device Quality Management System).
