Cleanroom Grade

Sterility

Material

Length

Type

  • Isofield Exa 230

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • GMP Grade A compatible
    • ISO Class 4 & 5 compatible
    • Sterile
    • 230mm length with malleable nose strip
    • Earloops: Non-latex knitted earloops with green clip fastener
    • Outer material: Non-woven Spunbond Polyester
    • Filter material: Non-woven Meltblown Polyester
    • Inner material: Non-woven Polypropylene/Polyethylene

    Processed in a NEBB Certified ISO Class 5 environment Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

    60011

    Size Universal

    • 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

    • One 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

    Sterile Earloop Cleanroom Facemasks with Clips

    , , , Details

  • Isofield Peta 230

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • ISO Class 4 & 5 compatible
    • Non-Sterile
    • 230mm length with enclosed malleable nose strip
    • Earloops: Non-latex knitted earloops
    • Outer material: Non-woven Spunbond Polyester
    • Filter material: Non-woven Meltblown Polypropylene
    • Inner material: Non-woven Polypropylene/Polyethylene

    Processed in a NEBB Certified ISO Class 5 environment

    60210

    Size Universal

    • 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

    • One 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)

    • Preparation of solutions to be sterile-filtered
    • Cleaning of equipment after blending
    • Removal and cooling of items from heat sterilizers

    Non-sterile Earloop Cleanroom Facemasks with Clips

    , , Details

  • Isofield Tera 230

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • GMP Grade A compatible
    • ISO Class 4 & 5 compatible
    • Sterile
    • 230mm length with malleable nose strip
    • Tie-tapes: Non-woven Polypropylene
    • Outer material: Non-woven Spunbond Polyester
    • Filter material: Non-woven Meltblown Polyester
    • Inner material: Non-woven Polypropylene/Polyethylene

    Processed in a NEBB Certified ISO Class 5 environment Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

    60131

    Size Universal

    • 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

    • One 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 Tie-On Cleanroom Facemasks

    , , Details

  • Isofield Zetta 230

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • ISO Class 4 & 5 compatible
    • Non-sterile
    • 230mm length with enclosed malleable nose strip
    • Tie tapes: Non-woven Spunbond Polypropylene
    • Outer material: Non-woven Polypropylene/Polyethylene
    • Filter material: Non-woven Meltblown Polypropylene
    • Inner material: Non-woven Polypropylene/ Polyethylene

    Processed in a NEBB Certified ISO Class 5 environment

    60330

    Size Universal

    • 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

    • 50 pieces per sealed inner PE bag,
    • One inner bag per sealed outer PE bag,
    • 16 outer bags per lined carton (800 pieces)

    • Weighing and measuring ingredients
    • Testing of non-sterile liquid and semi-solid
    • Handling of components before and after washing

    Non-sterile Tie-On Cleanroom Facemasks

    , , Details

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