Isofield Eclipse

5/5

DATA SHEET
DECLARATION OF CONFORMITY

VALIDATION PACK
DECLARATION OF CONFORMITY
CERTIFICATE FINDER

  • Sterile nitrile Cleanroom gloves
  • 400mm (16”) elbow length
  • Hand-specific
  • White colour
  • Textured palm & fingers
  • Beaded cuff
  • Low endotoxin
  • Gamma irradiation, minimum 25kGy
  • Sterility Assurance Level 10-6
  • Tested against a range of chemotherapy drugs
  • IPA resistant ink pouches

  • 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 quality management system

Processed in a NEBB certified ISO Class 5 Cleanroom

Physical properties comply with European medical glove standard EN455-2:2015

Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

20440

Size 6.0 2044060
Size 6.5 2044065
Size 7.0 2044070
Size 7.5 2044075
Size 8.0 2044080
Size 8.5 2044085
Size 9.0 2044090
Size 10.0 20440100

  • 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 PE wallet,
  • 1 PE wallet per sealed PE pouch,
  • 10 pouches per PE bag,
  • 20 sealed PE bags per lined carton (200 pairs)

  • Aseptic assembly of filling equipment
  • Filtration, filling, stoppering and capping of vials
  • Aseptic compounding and mixing
  • Staging and conveying of sterile primary packaging components

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

Description

400mm (16”) Sterile nitrile Cleanroom gloves – Hand-specific

Additional information

Cleanroom Grade

,

Length

Material

Sterility

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