Isofield Exa 230

5/5

DATA SHEET
DECLARATION OF CONFORMITY
VALIDATION PACK
CERTIFICATE FINDER

  • 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

60011

Size Universal

    • 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

SKU: 10130-1-1-2 Category: Tags: , , ,

Description

Validated Sterile Earloop Cleanroom Facemask with Clip

Additional information

Cleanroom Grade

,

Sterility

Types

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