Cleanroom Grade

Sterility

Material

Length

Categories

Type

  • Isofield Volta

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

    PRODUCT INFO

    • GMP Grade A compatible
    • ISO Class 4 & 5 compatible
    • Sterile
    • Nitrile
    • Neon green colour
    • Length 300mm (12”)
    • Hand specific
    • Textured fingers
    • Beaded cuff
    • Accelerator free
    • Low endotoxin levels

    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

    20530

    Size 6.0 2053060
    Size 6.5 2053065
    Size 7.0 2053070
    Size 7.5 2053075
    Size 8.0 2053080
    Size 8.5 2053085
    Size 9.0 2053090
    Size 10.0 20530100

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

    • Manufacture of sterile liquid and lyophilized vials
    • Filtration, filling, stoppering and capping of vials
    • Aseptic compounding and mixing
    • Preparation of sterile emulsions

    Sterile 300mm (12″) Cleanroom Nitrile Hand Specific Gloves

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  • Isofield CRN+

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

    PRODUCT INFO

    • GMP Grade A compatible
    • ISO Class 4 & 5 compatible
    • Sterile
    • Nitrile
    • White colour
    • Elbow length 400mm (16”)
    • Ambidextrous
    • Textured palm & fingers
    • Beaded cuff

    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

    20240

    Small 6.0-6.5 20240S
    Medium 7.0-7.5 20240M
    Large 8.0-8.5 20240L
    XLarge 9.0 20240XL

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

    • Manufacture of sterile liquid and lyophilized vials
    • Filtration, filling, stoppering and capping of vials
    • Aseptic compounding and mixing
    • Preparation of sterile emulsions

    Sterile 400mm (16″) Cleanroom Nitrile Gloves

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  • Isofield CR+

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

    PRODUCT INFO

    • GMP Grade A compatible
    • ISO Class 4 & 5 compatible
    • Sterile
    • Latex
    • Natural colour
    • Elbow length 400mm (16”)
    • Ambidextrous
    • Textured palm & fingers
    • Beaded cuff
    • Protein level less than 50μg/g
    • Double-donnable

    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

    10040

    Small 6.0-6.5 10040S
    Medium 7.0-7.5 10040M
    Large 8.0-8.5 10040L
    XLarge 9.0 10040XL

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

    • Aseptic compounding and mixing
    • Preparation of sterile emulsions
    • Manufacture of sterile liquid and lyophilized vials
    • Filtration, filling, stoppering and capping of vials

    Sterile 400mm (16″) Cleanroom Latex Gloves

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  • Isofield Zetta 230

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

    PRODUCT INFO

    • ISO Class 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

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  • Isofield Peta 230

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

    PRODUCT INFO

    • ISO Class 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

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  • 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

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  • 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

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  • Isofield Isoclave IV

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

    PRODUCT INFO

    • GMP Grade A compatible
    • ISO Class 5 compatible
    • Indirect upper and lower ventilation
    • Panoramic visibility
    • Fits over standard prescription glasses
    • Ergonomic frame with flexible nose skirt to ensure secure fit
    • Premium anti-scratch, optical grade, anti-fog lens
    • Frame: Tested to withstand 40 autoclave cycles (30 minutes duration at 121°C, under laboratory conditions)
    • Lens: Tested to withstand 35 autoclave cycles (30 minutes duration at 121°C under laboratory conditions)

    Manufactured in a facility operating under ISO 9001 quality management system Complies with relevant requirements in EN166:2001 Sterilization: Non-sterile. Goggle must be autoclaved prior to use.

    50110

    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 PE bag,
    • 10 pieces per inner box,
    • 5 boxes per carton (50 pieces)

    • Preparation of sterile emulsions
    • Filling of glass vials and syringes
    • Handling of sterile equipment

    Autoclavable Cleanroom Goggles

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  • Isofield NS400

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

    PRODUCT INFO

    • ISO Class 5 compatible
    • Non-sterile
    • Nitrile
    • White colour
    • Elbow length 400mm (16”)
    • Ambidextrous
    • Textured palm and fingers
    • Beaded cuff
    • Low endotoxin levels

    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

    20340

    Small 20340S
    Medium 20340M
    Large 20340L
    XLarge 20340XL
    XXLarge 20340XXL

    • 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

    • 100 gloves per sealed inner PE bag,
    • One inner PE bag per sealed outer PE bag,
    • 10 outer bags per lined carton (1000 pieces)

    • Handling of components before and after washing
    • Transportation and loading of  vials
    • Preparation of ointments and creams before filling

    Non-sterile 400mm (16″) Cleanroom Nitrile Gloves 

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  • Isofield NS300

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

    PRODUCT INFO

    • ISO Class 5 compatible
    • Non-sterile
    • Nitrile
    • White colour
    • Length 300mm (12”)
    • Ambidextrous
    • Textured fingers
    • Beaded cuff
    • Low endotoxin levels

    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

    20130

    Small 20130S
    Medium  20130M
    Large  20130L
    XLarge  20130XL
    XXLarge  20130XXL

    • 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

    • 100 gloves per sealed inner PE bag,
    • One inner PE bag per sealed outer PE bag,
    • 10 outer bags per lined carton (1000 pieces)

    • Preparing equipment for autoclave
    • Weighing and measuring ingredients
    • Cleaning of equipment
     

    Non-sterile 300mm (12″) Cleanroom Nitrile Gloves 

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  • Isofield LS400

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

    PRODUCT INFO

    • ISO Class 5 compatible
    • Non-sterile
    • Latex
    • Natural colour
    • Elbow length 400m (16”)
    • Ambidextrous
    • Textured palm & fingers
    • Beaded cuff
    • Protein level less than 50μg/g
    • Double-donnable

    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

    10140

    Small 10140S
    Medium 10140M
    Large 10140L
    XLarge 10140XL
    XXLarge 10140XXL

    • 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

    • 100 gloves per sealed inner PE bag,
    • One inner PE bag per sealed outer PE bag,
    • 10 outer bags per lined carton (1000 pieces)

    • Handling of washed components
    • Preparation of solutions to be sterile-filtered
    • Loading and transporting vials

    Non-sterile 400mm (16″) Cleanroom Latex Gloves 

    , , Details

  • Isofield CR++

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

    PRODUCT INFO

    • GMP Grade A compatible
    • ISO Class 4 & 5 compatible
    • Sterile
    • Latex
    • Natural colour
    • Shoulder length 600mm (24”)
    • Hand specific
    • Textured palm and fingers
    • Beaded cuff
    • Protein level less than 50μg/g

    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

    10360

    Size 6.5 1036065
    Size 7.0 1036070
    Size 7.5 1036075
    Size 8.0 1036080
    Size 8.5 1036085
    Size 9.0 1036090

    • 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 pair per inner PE wallet,
    • One PE wallet per sealed PE pouch, 10 pouches per PE bag,
    • 10 sealed PE bags per lined carton (100 pairs)

    • Loading and unloading of lyophilizer or depyrogenation tunnel
    • Blending granulates and powders
    • Transfer of partially closed containers used in freeze-drying
    • Sterile lyophilization of parenteral drug products

    Sterile 600mm (24″) Cleanroom Latex Hand Specific Gloves

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