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
GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom
Manufactured in a facility operating under ISO 9001: 2015 quality management system
Processed in a NEBB certified ISO Class 5 Cleanroom
80231
XXSMALL
80231XXS
XSMALL
80231XS
SMALL
80231S
MEDIUM
80231M
LARGE
80231L
XLARGE
80231XL
XXLARGE
80231XXL
3XLARGE
80231XXXL
4XLARGE
80231XXXXL
5XLARGE
80231XXXXXL
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
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)
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
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
GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom
Processed in a NEBB Certified ISO Class 5 environment
Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015
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
1 piece per sealed inner PE bag,
50 inner bags per sealed outer PE bag,
10 outer bags per lined carton (500 pieces)
Loading vials into a sterile lyophilizer
Aseptic filling, sealing, transfer of stoppered vials
Blending granulates and powders
Sterile Cleanroom overboots
Extra long — 50 CM knee height
Two ties for added security
Anti-slip PU sole
Aseptically folded
GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom
Manufactured in a facility operating under ISO 9001: 2015 quality management system
Processed in a NEBB certified ISO Class 5 Cleanroom
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
1 pair per inner bag,
10 pairs per outer bag,
8 outer bags per carton,
80 pairs per carton
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
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