Isofield Tera 230

Validated sterile tie-on Cleanroom facemask, 230mm width 
The Isofield Tera is the widest validated sterile Cleanroom facemask available. 230mm wide, with comfortable polyester ties, the Tera is made from gamma compatible materials ensuring low / no odour in use. The individually packed Tera has excellent bacterial and particle filtration efficiency and is GMP Grade A compatible.

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APPLICATION 
Loading vials into a sterile lyophilizer 
Aseptic filling, sealing, transfer of stoppered vials 
Blending granulates and powders

PRODUCT INFO 
Validated sterile tie-on Cleanroom facemask 
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 
60131 
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 per sealed inner PE bag, 
50 inner bags per sealed outer PE bag, 
10 outer bags per lined carton (500 pieces)

  • DATA SHEET
  • QUALITY ASSURANCE 
    Processed in a NEBB Certified ISO Class 5 environment 
    Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

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