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  6. Isofield™ Alpha Sterile Kits - Grade A/B Compatible

Isofield™ Alpha Sterile Kits - Grade A/B Compatible
BIOPHARMA

Produktkod. 30178882
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30178882 Large
30178845 Small
30178813 Medium
30178899 X-Large
30178827 2X-Large
30178891 3X-Large
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Produktkod. 30178882 Leverantör Isofield™ Leverantörsnummer 80551L
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Description

The Alpha sterile kit with hood with integrated mask, coverall with mandarin collar, and over boots are aseptically folded and tested against chemo to ASTM F 739. The anti-static, low linting, PPE Cat III Kits provide protection in Grade A/B environments for all cleanroom activities.

MANDARIN COLLAR COVERALL

  • GMP Grade A and B and ISO Class 4 and 5 cleanroom compatible
  • Two-layer mandarin collar provides secure fit at neck area
  • Zip flap with double-sided tape prevents ingress and egress of particles
  • Low-linting, anti-static fabric suitable for chemo handling
  • Elasticated thumb loops
  • Back elastic to prevent bellows effect

HOOD

  • Latex-free enclosed elastic face opening for comfortable fit
  • Extra-long yoke for added protection
  • Three panel hood design to minimize skin exposure

OVERBOOTS

  • Extra-long knee height
  • Two-ties for added security
  • Anti-slip PU sole

Technical and Documentation Compliance

  • COA, COC, COI Available for download online
  • QR Code on cartons allows for immediate Document retrieval
  • Passed Type 5 ( EN ISO 13982-1:2004 and EN 13982-2:2004) and Type 6 ( EN 13034:2005+A1:2009) test
  • Repellency to chemicals and Resistance to Penetration by chemicals EN 14325:2004, EN ISO 6530:2005
  • Abrasion Resistance EN 14325:2004, EN ISO 12947-2:2016
  • Flex Cracking Resistance EN 14325:2004, EN ISO 7854:1997, Method B
  • Trapezoidal Tear Resistance EN 14325:2004
  • Machine Direction and Cross Direction EN ISO 9073-4:1997
  • Tensile Strength, Cross Direction EN 14325:2004, EN ISO 13934-1:2013
  • Machine Direction EN ISO 13934-1:2013
  • Puncture Resistance EN 14325:2004, EN 863:1995
  • Seam Strength EN 14325:2004 [5.5]
  • Inward Leakage of aerosols and fine particles into suits EN ISO 13982- 2:2004
  • IL 82/90 EN ISO 13982- 1:2004
  • IL 8/10 (Type 5)
  • Resistance to penetration by a spray of liquid (Spray Test) EN 13034:2015 + A1:2009, ISO 17491-4:2008, (Type 6)
  • Permeation of Liquids and Gases through Protective Clothing under conditions of Continuous Contact ASTM F739-20
  • Sterility Validation EN ISO 11137 Part 2 : 2015
  • Particulate Cleanliness – Helmke Drum Test : Class 1
  • Surface Resistivity ASTM D257

Specifications

Renrumsklass Class 100 (ISO 5)
Färg White
Material Polyethylene, Non-woven Polypropylene Laminate
Produkttyp PPE Kit
Storlek Large
Förslutningstyp Elastic
Manschettstil Covered Elastic
Hals stil Collared
Sömtyp Bound
Disponibel Single-use
Motstånd Chemicals, Anti-static, Liquid, Particle
Antal fickor None
Sterilitet Sterile
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