Grade C/D

  • Cleanroom goggles and glasses with a decorative background
    Cleanroom goggles and glasses with a decorative backgroundCleanroom goggles and glasses in a box with a decorative background

    Isofield Isoclave CF

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • Autoclavable Cleanroom goggles
    • Anti-fog & premium anti-scratch lens
    • Indirect upper ventilation & non-vented bottom
    • Panoramic visibility
    • Fits over standard prescription glasses
    • Ergonomic frame with flexible nose skirt to ensure secure fit
    • Non-sterile, goggle must be processed prior to use

    • 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

    50210

    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 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 8.8kg
    Carton Size W39.5 L44 H55cm
    Nett Weight 5.8kg
    Air Freight Pallet
    Max height: 125cm
    Layers: 2
    Cartons: 8
    Sea Freight Pallet
    Max height: 180cm
    Layers: 3
    Cartons: 12

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 8.8kg
    Carton Size W39.5 L44 H55cm
    Nett Weight 5.8kg
    Air Freight Pallet
    Max height: 125cm
    Layers: 2
    Cartons: 12
    Sea Freight Pallet
    Max height: 180cm
    Layers: 3
    Cartons: 18

    Close-fit autoclavable Cleanroom goggles

    GMP Annex 1 compatible autoclavable goggle with an indirect vent at the top and a non-vented bottom for additional safety. The Isoclave CF is made with super soft silicon housing to ensure comfort and a wide view anti-fog coated lens. Suitable for autoclaving at 121 °C for 30 minutes, the Isoclave CF offers up to 35 cycles on the lens and 40 on straps and housing, under lab conditions. The CF is supplied with a clip strap fastener for easy donning and may be worn over eyeglasses.

    , , , Details
  • Cleanroom socks with a decorative background
    Cleanroom socks with a decorative backgroundCleanroom socks in a box with a decorative background

    Isofield Cos

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • Non-sterile lightweight Cleanroom socks
    • 95% polyester, 5% spandex
    • Mid-calf length
    • White colour
    • Three sizes for added flexibility
    • Low linting

    • ISO Class 4 cleanroom
    • ISO Class 5 cleanroom
    • Class 10 cleanroom
    • Class 100 cleanroom

    Manufactured in a facility operating under ISO 9001:2015 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom

    70610

    Small/Medium 70610S - M
    Large/X-Large 70610L - XL
    XXLarge 70610-XXL

    • 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

    • 10 pairs per double bag,
    • 50 sealed outer cleanroom bags per carton,
    • 500 pairs per carton

    • Pharmaceutical product preparation
    • Cleanroom cleaning and preparation
    • Medical device manufacturing
    • Blending operations for biotechnologies
    • Handling of active materials
    • Maintenance of equipment and instruments

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 13.8 - 16.2kg
    Carton Size W40 L44 H55cm
    Nett Weight  12.6 - 15.0kg
    Air Freight Pallet Max Height: 125cm Layers: 2 Cartons: 8
    Sea Freight Pallet Max Height: 128cm Layers: 3 Cartons: 12

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 13.8 - 16.2kg
    Carton Size W40 L44 H55cm
    Nett Weight 12.6 - 15.0kg
    Air Freight Pallet Max Height: 141cm Layers: 2 Cartons: 12
    Sea Freight Pallet Max Height: 162cm Layers: 3 Cartons: 18

    Non-sterile lightweight Cleanroom socks

    The Isofield Cos single-use non-sterile lightweight cleanroom sock is GMP Annex 1 compatible, offering comfort and protection in cleanroom settings. Available in three sizes, the Cos hourglass heel design ensures comfort levels rivaling most reusable alternatives.

    , Details
  • 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 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.

    , , Details
  • 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.

    , , Details
  • Cleanroom Goggles on a decorative background
    Cleanroom gloves with a decorative backgroundCleanroom goggles in a box with a decorative background

    Isofield Isoclave IV

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

    PRODUCT INFO

    • Indirect upper and lower ventilation
    • Panoramic visibility
    • Fits over standard prescription glasses
    • Ergonomic frame with flexible nose skirt
    • Premium anti-scratch, optical grade, anti-fog lens
    • Tested against EN 166 and ISO 16321-1
    • Certified to PPE Cat II
    • Non-sterile – goggle must be processed prior to use

    • 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 Complies with relevant requirements in EN166:2001

    50110

    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 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 8.5kg
    Carton Size W39.5 L44 H55cm
    Nett Weight 5.5kg
    Air Freight Pallet
    Max height: 125cm
    Layers: 2
    Cartons: 8
    Sea Freight Pallet
    Max height: 180cm
    Layers: 3
    Cartons: 12

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 8.5kg
    Carton Size W39.5 L44 H55cm
    Nett Weight 5.5kg
    Air Freight Pallet
    Max height: 125cm
    Layers: 2
    Cartons: 12
    Sea Freight Pallet
    Max height: 180cm
    Layers: 3
    Cartons: 18

    Indirect vent autoclavable Cleanroom goggles

    GMP Annex 1 compatible autoclavable goggle with indirect venting. The Isoclave IV is made with a super soft thermoplastic housing to ensure comfort, and a wide view anti-fog coated lens. Suitable for autoclaving at 121°C for 30 mins, the Isoclave IV offers up to 35 cycles on the lens and 40 on straps and housing, under lab conditions.

    , , , Details
  • Cleanroom gloves
    Cleanroom gloves with a decorative backgroundCleanroom gloves in a box with a decorative background

    Isofield NS400

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

    PRODUCT INFO

    • Non-sterile nitrile Cleanroom gloves
    • 400mm (16”) elbow length
    • Ambidextrous
    • White colour
    • Textured palm and fingers
    • Beaded cuff
    • Low endotoxin levels
    • Tested against a range of chemotherapy drugs
    • Complies with EU food grade Regulation (EU) No 10/2011

    • ISO Class 5 cleanroom
    • ISO Class 4 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

    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,
    • 1 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 11.3 - 14.9kg
    Carton Size W28 L43 H31cm
    Nett Weight 9.3 - 12.9kg
    Air Freight Pallet
    Max height: 139cm
    Layers: 4
    Cartons: 24
    Sea Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 30

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 11.3 - 14.9kg
    Carton Size W28 L43 H31cm
    Nett Weight 9.3 - 12.9kg
    Air Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 40
    Sea Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 40

    400mm (16″) Non-sterile nitrile Cleanroom gloves

    The Isofield NS400 400mm(16″) non-sterile nitrile extended cuff offers excellent elbow length protection for ISO class 4 cleanrooms and above. Triple washed in deionized water, the ultra-clean, food grade NS400 is Chemotherapy tested to ASTM D 6978-05, has low endotoxin and is smooth enough for double donning whilst also offering a textured palm & fingers for added grip.

    , Details
  • Cleanroom Gloves holding medication on a decorative background
    Cleanroom gloves with a decorative backgroundCleanroom gloves in a box with a decorative background

    Isofield NS300

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

    PRODUCT INFO

    • Non-sterile nitrile Cleanroom gloves
    • 300mm (12”) length
    • Ambidextrous
    • White colour
    • Textured fingers
    • Beaded cuff
    • Low endotoxin levels

    • 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

    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,
    • 1 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 6.3 - 8.3kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.5 - 6.5kg
    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 6.3 - 8.3kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.5 - 6.5kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60
     

    300mm (12″) Non-sterile nitrile Cleanroom gloves

    The Isofield NS300 300mm (12″) non-sterile nitrile Cleanroom glove is ideal for ISO Class 4 cleanrooms and above. Triple washed in deionized water, the ultra-clean NS300 is accelerator free, has low endotoxin, and is smooth enough for double donning whilst also offering a textured palm and fingers for added grip.

    , Details
  • LS400 Non-sterile latex Cleanroom gloves
    Cleanroom gloves with a decorative backgroundCleanroom gloves in a box with a decorative background

    Isofield LS400

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

    PRODUCT INFO

    • Non-sterile latex Cleanroom gloves
    • 400mm (16") elbow length
    • Ambidextrous
    • Natural colour
    • Textured palm & fingers
    • Low endotoxin levels
    • Beaded cuff
    • Protein level less than 50µg/g
    • Double-donnable
    • IPA resistant ink pouches

    • 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

    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,
    • 1 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 14.1 - 16.4kg
    Carton Size W28 L43 H31cm
    Nett Weight 12.1 - 14.4kg
    Air Freight Pallet
    Max height: 139cm
    Layers: 4
    Cartons: 24
    Sea Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 30

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 14.1 - 16.4kg
    Carton Size W28 L43 H31cm
    Nett Weight 12.1 - 14.4kg
    Air Freight Pallet
    Max height: 139cm
    Layers: 4
    Cartons: 32
    Sea Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 40

    400mm (16″) Non-sterile latex Cleanroom gloves

    The Isofield LS400 400mm (16″) non-sterile latex extended cuff Cleanroom gloves offer excellent elbow-length protection for ISO Class 4 cleanrooms and above. This ultra clean latex glove is triple washed in deionized water and its surface is smooth enough for double-donning whilst also offering a textured palm & fingers for added grip. Every lot of LS400 is tested for endotoxin and has very low levels of detectable protein (less than 50 µg/g)

    , Details
  • Cleanroom Gloves
    Cleanroom gloves with a decorative backgroundCleanroom gloves in a box with a decorative background

    Isofield LS300

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

    PRODUCT INFO

    • Non-sterile latex Cleanroom gloves
    • 300mm (12”) length
    • Ambidextrous
    • Natural colour
    • Textured palm & fingers
    • Beaded cuff
    • Low endotoxin levels
    • Protein level less than 50µg/g
    • Double donnable
    • IPA resistant ink pouches

    • 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

    10230

    Small 10230S
    Medium 10230M
    Large 10230L
    XLarge 10230XL
    XXLarge 10230XXL

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

    • Testing of non-sterile liquids and semi-solids
    • Preparation of suspensions and emulsions before filling
    • Loading and transporting vials

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 9.7 - 13.6kg
    Carton Size W28 L43 H30cm
    Nett Weight 7.9 - 11.8kg
    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 9.7 - 13.6kg
    Carton Size W28 L43 H30cm
    Nett Weight 7.9 - 11.8kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

    300mm (12″) Non-sterile latex Cleanroom gloves

    The Isofield LS300 300mm (12″) non-sterile latex Cleanroom gloves are ideal for ISO Class 4 cleanrooms and above. This ultra clean latex glove is triple washed in deionized water and its surface is smooth enough for double-donning whilst also offering a textured palm & fingers for added grip. Every lot of LS300 is tested for endotoxin and has very low levels of detectable protein (less than 50 µg/g)

    , Details

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