Isofield Exa 230

Validated sterile earloop Cleanroom facemask with clip, 230mm width 
The Isofield Exa is the widest validated sterile Cleanroom facemask available. 230mm wide, with comfortable ear loops, the Exa is also fitted with a convenient clip to adapt to your SOP, and is made with gamma compatible materials to ensure low/no odour in use. The individually packed Exa has excellent bacterial and particle filtration efficiency and is GMP Grade A/B cleanroom compatible.

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APPLICATION 
Removal and cooling of items from heat sterilizers 
Handling sterile starting materials and components 
Replenishment of sterile product, containers and closures

PRODUCT INFO 
Validated sterile earloop Cleanroom facemask with clip 
230mm length with a malleable nose strip, providing a secure fit and full face coverage 
3-layer non-woven configuration 
Highly efficient bacterial and particle filtration 
Gamma irradiation, minimum 25kGy 
Sterility Assurance Level 10-6 
Particle Shedding (Helmke Drum) Category I 
IPA resistant ink pouches to maintain traceability 

CLEANROOM COMPATIBILITY 
GMP Grade A cleanroom 
GMP Grade B cleanroom 
ISO Class 4 cleanroom 
ISO Class 5 cleanroom 
Class 10 cleanroom 
Class 100 cleanroom

PRODUCT CODE & SIZE 
60011 
Size Universal 

SHELF LIFE & STORAGE 
Shelf Life 
Five (5) years from date of manufacture 
Storage 
Store in a dry, cool place (<40°C) away from direct sunlight 
Do not expose open cartons to prolonged direct fluorescent light 

PACKAGING 
1 piece (with green clip) per sealed inner PE bag, 
50 inner bags per sealed outer PE bag, 
12 outer bags per lined carton (600 pieces)

  • DATA SHEET
  • DECLARATION OF CONFORMITY
  • QUALITY ASSURANCE 
    Manufactured in a facility operating under an ISO 9001:2015 quality management system 
    Processed in a NEBB Certified ISO Class 5 environment 
    Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

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