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Dastex Group GmbHDastex Group GmbH

Disposable face mask

sterile, with elastic ear loops and green fastening clip

Back to the face mask in the product portfolio
Width
Bacterial Filtration Efficiency
Particulate Filtration Efficiency
Pressure difference delta P
sterile
latex-free
three layer

Disposable garments for the facial area

Isofield Exa 230 with elastic ear loops, green fastening clip, Art. No. 43723
23 cm
97 % bei 0,3 μm
94 % bei 0,1 μm
6,8
  • sterile
  • without natural latex
  • disposable face mask with elastic knitted round ear loops, green fastening clip
  • extra wide coverage (23 cm)
  • „OUT“ embossing for a correct fitting
  • three layer non-woven, triple folded
  • gamma irradiated
  • individually packed and sealed in a polyethylene bag
  • extra wide coverage   
  • high bacterial and particulate filtration efficiency
  • packed under controlled conditions
  • triple packed in PE bags for a safe transfer to cleanrooms and zones of technical cleanliness
  • aseptic filling and production
  • for laboratory requirements
  • in particulate and microbiological monitored cleanrooms and zones of technical cleanliness
  • as a supplement to the reusable consumable goods concept

Product recommen­dation based on cleanroom classes

Air cleanliness class EN ISO 14644-1
particulate monitored areas

123456789low dust

Hygiene zones according to GMP
microbiological monitored areas

ABCDE

Eine 1:1-Zuordnung von Mundschutzen zu einer Luftreinheitsklasse gemäß ISO 14644-1 ist nicht möglich. Lediglich aufgrund spezieller, aus reinraumtechnischer Sicht relevanter Eigenschaften wie z. B. „Abriebfestigkeit“ oder „Partikelemission“ und zum Teil „Filtrationseffizienz“ können Empfehlungen ausgesprochen werden. In der VDI-Richtlinie 2083 Blatt 9.2 Kapitel 6 finden Anwender weitere Hinweise hierzu.

Technical data

  Unit of measurement Value Test method
Type of material (face mask)   non-woven spunbonded, embossed
non-woven meltblown
non-woven spunbonded 		 
Width (± 5 mm) cm 23  
Height (± 5 mm) cm 9.5  
Materials (face mask)
Outer layer
Inner layer (filter medium) 		 
Polyester (PES)
Polyester (PES)
  
Pleating   three times  
Type of attachment   Earloops, knitted, flat
fastening clip 		 
Materials (fastening)   Polyester (PES)
Polypropylen (PP), green) 		 
Material nose bridge/iron   completely covered,
malleable aluminium strip 		 
Seams   thermally bound  
Particle filtration efficiency (PFE) % at 0.1 µm 94 Nelson Labs Standard Test
Protocol No. STP0005 Rev 08
complies with exceptions ASTM F2101-19
Bacterial filtration efficiency (BFE) % at 0.3 µm 97 Nelson Labs Standard Test
Protocol No. STP0004 Rev 18
complies with ASTM F2299, EN 14683:2019 Annex B and
US FDA GMP Regulations 21 CFR Parts 210, 211, 820
Breathability / differential pressure (∆P) mm H2O/cm2 6.8 Nelson Labs Standard Test
Protocol No. STP0004 Rev 18
complies with ASTM F2101-19 and
EN 14683:2019 Annex C
Viral filter efficiency (VFE) % per x l/min A. n. s.  
Airborne particles
(Helmke Drum TC-05 +
Handheld Particle Counter) 		(10 cycles - counts/min)
≥ 0.3 µm
≥ 0.5 µm
≥ 5 µm
65.00
46.28
3.34
meets class 1 		IEST-RP-CC003.4
Garment System Considerations for Cleanrooms
and Other Controlled Environments
Sterility kGy ≥ 25 n. s.
Colour (face mask/banding)   white/white  
PU   600 pieces
single packed (with green clip) in a sealed PE bag
50 pieces per sealed outer PE bag,
12 outer bags per lined carton 		 

The manufacturer's technical data listed above are typical values at the time of publication. They are not specifications. All data are without guarantee, changes are possible without prior notice.