Isofield Steridon with Integrated Facemask

Sterile Cleanroom coverall with hood & integrated facemask 
The Isofield Steridon Cleanroom coverall with an integrated facemask is aseptically folded and can be donned in 60 seconds or less. It is validated sterile via X-ray and tested against chemo to ASTM F 739. The anti-static, low-linting, viral barrier provides essential protection in Grade A/B environments for all cleanroom activities.

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APPLICATION 
Applications where fluid protection, viral barrier, low particle emissions required 
Pharmaceutical product preparation 
Cleanroom cleaning and preparation 
Aseptic filling and labelling 
Medical device manufacturing 
Blending operations for biotechnologies 
Handling of active materials 
Maintenance of equipment and instruments

PRODUCT INFO 
Sterile Cleanroom coverall with integrated facemask 
Latex-Free, enclosed and elasticated face, wrists and ankles 
Ergo-fit design at back and shoulders allowing greater range of motion 
Integrated facemask with a guided tie-on system to facilitate easy donning and secure fit 
Aseptically presented fold 
Colour coded left & right inner tabs to facilitate ease of donning 
Removable external tabs at zipper to ensure sterile field maintained 
Validated for sterility by X-Ray 
Sterility Assurance Level (SAL) 10-6 

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 
80231 
XXSMALL 80231XXS 
XSMALL 80231XS 
SMALL 80231S 
MEDIUM 80231M 
LARGE 80231L 
XLARGE 80231XL 
XXLARGE 80231XXL 
3XLARGE 80231XXXL 
4XLARGE 80231XXXXL 
5XLARGE 80231XXXXXL 

SHELF LIFE & STORAGE 
Shelf Life 
Three (3) 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 cleanroom bag, 
1 inner bag per sealed outer bag, 
20 outer bags per carton liner with twist tie, 
20 pieces per carton (XXS-XXL) 
15 pieces per carton (3XL-5XL)

  • DATA SHEET
  • QUALITY ASSURANCE 
    Manufactured in a facility operating under ISO 9001: 2015 quality management system 
    Processed in a NEBB certified ISO Class 5 Cleanroom

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