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
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 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
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 (with green clip) per sealed inner PE bag,
50 inner bags per sealed outer PE bag,
12 outer bags per lined carton (600 pieces)
Removal and cooling of items from heat sterilizers
Handling sterile starting materials and components
Replenishment of sterile product, containers and closures
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
Irradiated tie-on cleanroom facemask with anti-fog visor
3-layer non-woven configuration
Threaded top ties to ensure secure fit to face
Anti-fog-coated visor
Highly efficient bacterial and particle filtration
Particle Shedding (Helmke Drum) Category I (mask only)
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
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
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,
25 inner bags per sealed outer PE bag,
8 outer bags per lined carton (200 pieces)
Pharmaceutical product preparation
Cleanroom cleaning
Medical device manufacturing
Blending operations
Handling of active materials
Cleanroom equipment maintenance
Close product quick view ×