Cleanroom Facemasks

  • Cleanroom mask and hood with a decorative background
    Cleanroom mask and hood with a decorative backgroundCleanroom Facemask

    Isofield Atto 230

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • 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

    60521

    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 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 5.02kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.22kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 32
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 40

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 5.02kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.22kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

    Irradiated tie-on Cleanroom facemask with anti-fog visor

    Gamma irradiated visor facemask. 230mm (9”) wide with long length ties, threaded through the visor to ensure a close fit to user. The Atto is made from low-linting cleanroom grade material. It has excellent Bacterial and particle filtration efficiency, with an anti-scratch & anti-fog visor.

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  • cleanroom facemask on a decorative background
    cleanroom facemask on a decorative backgroundcleanroom facemask on a decorative backgroundcleanroom goggles on a personCleanroom Facemask

    Isofield Exa 230

    Safety codes
    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 4.76kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 2.96kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 42
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 40

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 4.76kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 2.96kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 42
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 49

    Validated sterile earloop Cleanroom facemask with clip, 230mm width

    The Isofield Exa is the widest validated sterile Cleanroom facemask available. 230mm wide, with comfortable ear loops, the Exa is also fitted with a convenient clip to adapt to your SOP, and is made with gamma compatible materials to ensure low/no odour in use. The individually packed Exa has excellent bacterial and particle filtration efficiency and is GMP Grade A/B cleanroom compatible.

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  • Isofield Exa+ Sterile Cleanroom Facemask
    Isofield Exa+ Sterile Cleanroom FacemaskIsofield Exa+ Sterile Cleanroom FacemaskIsofield Exa+ Sterile Cleanroom FacemaskIsofield Exa+ Sterile Cleanroom Facemask

    Isofield Exa+ 250

    Safety codes
    DATA SHEET
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • Ultra-Wide 250mm length with malleable nose strip
    • Validated sterile earloop Cleanroom facemask with clip
    • Large pouch style breathing chamber
    • Extended lower breathing chamber provides excellent coverage at neck
    • Highly efficient bacterial and particle filtration
    • Gamma irradiation, minimum 25 kGy
    • Sterility Assurance Level 10-6
    • Particle Shedding (Helmke Drum) Category I
    • Printed with IPA resistant ink 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

    60411

    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 per sealed inner PE bag,
    • 50 inner bags per sealed outer PE bag,
    • 10 outer bags per lined carton (500 pieces)

    • Removal and cooling of items from heat sterilizers
    • Handling sterile starting materials and components
    • Replenishment of sterile product, containers and closures

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 5.2kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 3.4kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 36
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 42

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 5.2kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 3.4kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 42
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 49

    Validated sterile pouch-style earloop Cleanroom facemask with clip

    The Isofield Exa+, the world’s widest sterile pouch-style facemask. 250mm wide, with comfortable ear loops, and an extra large breathing chamber for operator comfort, the Exa+ features an extended lower chamber to increase face & neck coverage. The Exa+ is also fitted with a convenient clip to adapt to your SOP. The individually packed Exa+ has excellent Bacterial and particle filtration efficiency, is GMP Grade A compatible & is made from gamma compatible materials ensuring low / no odour in use.

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  • cleanroom facemask on a decorative background
    cleanroom facemask on a decorative backgroundcleanroom facemask on a decorative backgroundPPE/Cleanroom facemask with a decorative backgroundPPE/Cleanroom facemask in a box with a decorative background

    Isofield Peta 230

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

    PRODUCT INFO

    • Non-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
    • Particle Shedding (Helmke Drum) Category I
    • Individually packed to maintain low CFU count
    • IPA resistant ink pouches to maintain traceability
    • Earloops: Non-latex knitted earloops
    • Outer material: Non-woven Spunbond Polyester
    • Filter material: Non-woven Meltblown Polypropylene
    • Inner material: Non-woven Polypropylene/Polyethylene

    • 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

    60210

    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)

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 4.76kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 2.96kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 36
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 42

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 4.76kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 2.96kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 42
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 49

    • Micro electronic component manufacture
    • Wafer fabrication & semiconductor assembly
    • Medical device manufacturing areas
    • Cleaning of equipment after blending
    • Removal and cooling of items from heat sterilizers

    Non-sterile earloop Cleanroom facemask, 230mm width

    The Isofield Peta is ISO Class 4 cleanroom compatible. 230mm wide, with comfortable ear loops, the Peta is also fitted with a convenient clip to adapt to your SOP. The individually packed Peta has excellent Bacterial and particle filtration efficiency.

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  • Cleanroom Facemask from the side with a decorative background
    Cleanroom Facemask from the sidewith a decorative backgroundCleanroom Facemask from the rear with a decorative backgroundCleanroom facemask

    Isofield Tera 230

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • 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

    60131

    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 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 4.32kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 2.52kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 36
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 42

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 4.32kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 2.52kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 42
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 49

    Validated sterile tie-on Cleanroom facemask, 230mm width

    The Isofield Tera is the widest validated sterile Cleanroom facemask available. 230mm wide, with comfortable polyester ties, the Tera is made from gamma compatible materials ensuring low / no odour in use. The individually packed Tera has excellent bacterial and particle filtration efficiency and is GMP Grade A compatible.

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  • cleanroom facemask on a decorative background
    cleanroom facemask on a decorative backgroundcleanroom facemask on a decorative backgroundPPE/Cleanroom facemask with a decorative backgroundCleanroom Gloves

    Isofield Zetta 230

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • Non-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
    • Particle Shedding (Helmke Drum) Category I
    • Individually packed to maintain low CFU count
    • IPA resistant ink pouches to maintain traceability
    • Tie tapes: Non-woven Spunbond Polypropylene
    • Outer material: Non-woven Polypropylene/Polyethylene
    • Filter material: Non-woven Meltblown Polypropylene
    • Inner material: Non-woven Polypropylene/ Polyethylene

    • 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

    60330

    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 pieces per sealed inner PE bag,
    • 50 inner bag per sealed outer PE bag,
    • 10 outer bags per lined carton (500 pieces)

    • Micro electronic component manufacture
    • Wafer fabrication and semiconductor assembly
    • Medical device manufacturing areas
    • Cleaning of equipment after blending
    • Removal and cooling of items from heat sterilizers

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 4.32kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 2.52kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 36
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 42

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 4.32kg
    Carton Size W29.5 L47 H21cm
    Nett Weight 2.52kg
    Air Freight Pallet
    Max height: 141cm
    Layers: 6
    Cartons: 42
    Sea Freight Pallet
    Max height: 162cm
    Layers: 7
    Cartons: 49

    Non-sterile tie-on Cleanroom facemask

    The Isofield Zetta is ISO Class 4 cleanroom compatible. 230mm wide, with comfortable polyester ties, the Zetta is made from low-linting cleanroom grade material to ensure best-in-class cleanliness. The individually packed Zetta has excellent bacterial and particle filtration efficiency.

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