400mm (16")

  • 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 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 on a person against a decorative background
    PPE/Cleanroom gloves with a decorative backgroundcleanroom gloves on a decorative background

    Isofield CR+

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

    PRODUCT INFO

    • Sterile latex Cleanroom gloves
    • 400mm (16") elbow length
    • Ambidextrous
    • Natural colour
    • Textured palm & fingers
    • Beaded cuff
    • Low endotoxin levels
    • Gamma irradiation, minimum 25kGy
    • Sterility Assurance Level 10-6
    • Protein level less than 50µg/g
    • Double donnable
    • 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

    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

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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 9.1 - 10.8kg
    Carton Size W28 L32 H37cm
    Nett Weight  6.3 - 8.0 kg
    Air Freight Pallet Max Height: 126cm Layers: 3 Cartons: 24
    Sea Freight Pallet Max Height: 163cm Layers: 4 Cartons: 32

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 9.1 - 10.8kg
    Carton Size W28 L32 H37cm
    Nett Weight 6.3 - 8.0kg
    Air Freight Pallet Max Height: 126cm Layers: 3 Cartons: 36
    Sea Freight Pallet Max Height: 163cm Layers: 4 Cartons: 48

    400mm (16″) Sterile latex Cleanroom gloves

    The Isofield CR+ 400mm (16″) sterile latex Cleanroom glove with extended cuff offers excellent elbow length protection for GMP Grade A & B, 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 CR+ is tested for endotoxin and has very low levels of detectable protein (less than 50 µg/g).

    , , , Details
  • Sterile latex Cleanroom gloves with a decorative background
    cleanroom gloves being usedCleanroom Sterile nitrile gloves in a box

    Isofield CRN+

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

    PRODUCT INFO

    • Sterile nitrile Cleanroom gloves
    • 400mm (16”) elbow length
    • Ambidextrous
    • White colour
    • Textured palm & fingers
    • Beaded cuff
    • Low endotoxin levels
    • Gamma irradiation, minimum 25kGy
    • Sterility Assurance Level 10-6
    • Tested against a range of chemotherapy drugs
    • Complies with EU food-grade Regulation (EU) No 10/2011
    • 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

    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

    • 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)

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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 7.46 - 8.48kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.96 - 5.98kg
    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 7.46 - 8.48kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.96 - 5.98kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

    400mm (16″) Sterile nitrile Cleanroom gloves

    The Isofield CRN+ 400mm (16″) sterile nitrile extended cuff Cleanroom glove offers excellent elbow length protection for GMP Grade A & B, ISO Class 4 cleanrooms and above. Triple washed in deionized water the low endotoxin CRN+ has been tested for chemotherapy against ASTMD 6978-05, is anti-static, and double -donnable.

    , , , Details
  • person wearing cleanroom gloves on a decorative background
    Cleanroom gloves on a decorative backgroundwriting with cleanroom gloves onCleanroom Sterile nitrile gloves in a box

    Isofield Eclipse

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

    PRODUCT INFO

    • 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 7.6 - 8.3kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.8 - 5.5kg
    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 7.6 - 8.3kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.8 - 5.5kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

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

    The Isofield Eclipse 400mm (16″) sterile nitrile extended cuff Cleanroom glove with Arm-Lock technology offers excellent elbow length protection for GMP Grade A & B, ISO Class 4 cleanrooms and above. Triple washed in deionized water, the low endotoxin Isofield Eclipse has been tested for chemotherapy against ASTM D 6978-05, is accelerator free and anti-static.

    , , , Details
  • Cleanroom Coverall garment with facemask kit
    Cleanroom Coverall garment with facemask kitCleanroom Coverall garment with facemask kitCleanroom Coverall garment with facemask kitCleanroom Coverall garment with facemask kitCleanroom Coverall garment with facemask kit

    Isofield Steridon with Integrated Facemask

    DATA SHEET
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • Sterile Cleanroom coverall with integrated facemask
    • Latex-Free, enclosed and elasticated face, wrists and ankles
    • Ergo-fit design at back and shoulders allowing greater range of motion
    • Integrated facemask with a guided tie-on system to facilitate easy donning and secure fit
    • Aseptically presented fold
    • Colour coded left & right inner tabs to facilitate ease of donning
    • Removable external tabs at zipper to ensure sterile field maintained
    • Validated for sterility by X-Ray
    • Sterility Assurance Level (SAL) 10-6

    • 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: 2015 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom

    80231

    XXSMALL 80231XXS
    XSMALL 80231XS
    SMALL 80231S
    MEDIUM 80231M
    LARGE 80231L
    XLARGE 80231XL
    XXLARGE 80231XXL
    3XLARGE 80231XXXL
    4XLARGE 80231XXXXL
    5XLARGE 80231XXXXXL

    • 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 piece per sealed inner cleanroom bag,
    • 1 inner bag per sealed outer bag,
    • 20 outer bags per carton liner with twist tie,
    • 20 pieces per carton (XXS-XXL)
    • 15 pieces per carton (3XL-5XL)

    • Applications where fluid protection, viral barrier, low particle emissions required
    • Pharmaceutical product preparation
    • Cleanroom cleaning and preparation
    • Aseptic filling and labelling
    • Medical device manufacturing
    • Blending operations for biotechnologies
    • Handling of active materials
    • Maintenance of equipment and instruments

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 5.67 -7.04kg
    Carton Size W28  L43   H31cm
    Nett Weight 4.87 - 6.24kg
    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 5.67 -7.04kg
    Carton Size W28  L43   H31cm
    Nett Weight 4.87 - 6.24kg
    Air Freight Pallet
    Max height: 139cm
    Layers: 4
    Cartons: 32
    Sea Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 40

    Sterile Cleanroom coverall with hood & integrated facemask

    The Isofield Steridon Cleanroom coverall with an integrated facemask is aseptically folded and can be donned in 60 seconds or less. It is validated sterile via X-ray and tested against chemo to ASTM F 739. The anti-static, low-linting, viral barrier provides essential protection in Grade A/B environments for all cleanroom activities.

    , , , Details
  • Cleanroom Coverall garment kit
    Cleanroom Coverall garment kitCleanroom Coverall garment kitCleanroom Coverall garment kitCleanroom Coverall

    Isofield Steridon

    DATA SHEET
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • Sterile Cleanroom coverall with hood
    • Latex-free, enclosed and elasticated face, wrists and ankles
    • Ergo-fit design at back and shoulders allowing greater range of motion
    • Aseptically presented fold
    • Colour coded left & right inner tabs to facilitate ease of donning
    • Removable external tabs at zipper to ensure sterile field maintained
    • Validated for sterility by X-Ray
    • Sterility Assurance Level (SAL) 10-6

    • 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: 2015 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom

    80111

    XXSMALL 80111XXS
    XSMALL 80111XS
    SMALL 80111S
    MEDIUM 80111M
    LARGE 80111L
    XLARGE 80111XL
    XXLARGE 80111XXL
    3XLARGE 80111XXXL
    4XLARGE 80111XXXXL
    5XLARGE 80111XXXXXL

    • 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 piece per sealed inner cleanroom bag,
    • 1 inner bag per sealed outer bag,
    • 20 outer bags per carton liner with twist tie,
    • 20 pieces per carton (XXS-XXL)
    • 15 pieces per carton (3XL-5XL)

    • Applications where fluid protection, viral barrier, low particle emissions required
    • Pharmaceutical product preparation
    • Cleanroom cleaning and preparation
    • Aseptic filling and labelling
    • Medical device manufacturing
    • Blending operations for biotechnologies
    • Handling of active materials
    • Maintenance of equipment and instruments

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 5.56 - 6.93kg
    Carton Size W28  L43   H31cm
    Nett Weight 4.76 - 6.13kg
    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 5.56 - 6.93kg
    Carton Size W28  L43   H31cm
    Nett Weight 4.76 - 6.13kg
    Air Freight Pallet
    Max height: 139cm
    Layers: 4
    Cartons: 32
    Sea Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 40

    Sterile Cleanroom coverall with hood

    The tri-laminate Steridon Cleanroom coverall is aseptically folded and can be donned in 60 seconds or less. It is validated sterile via X-ray and tested against chemo to ASTM F 739. The anti-static, low-linting, viral barrier provides essential protection in Grade A/B environments for all cleanroom activities.

    , , , 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 gloves with a decorative background
    Cleanroom gloves in a box with a decorative background

    Isofield Blazer

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

    PRODUCT INFO

    • Sterile latex Cleanroom gloves
    • 300mm (12”) length
    • Hand-specific
    • Natural colour
    • Textured palm & fingers
    • Beaded cuff
    • Low endotoxin levels
    • Gamma irradiation, minimum 25kGy
    • Sterility Assurance Level 10-6
    • Protein level less than 50µg/g
    • High grip, high tack
    • 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

    10630

    Size 6.0 1063060
    Size 6.5 1063065
    Size 7.0 1063070
    Size 7.5 1063075
    Size 8.0 1063080
    Size 8.5 1063085
    Size 9.0 1063090
    Size 10.0 10630100

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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 6.14 - 7.46kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.34- 4.66kg
    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 6.14 - 7.46kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.34 - 4.66kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

    300mm (12”) Sterile latex Cleanroom gloves

    The Isofield Blazer 300mm (12″) sterile latex Cleanroom glove with a thicker cuff is an excellent option for GMP Grade A & B, ISO Class 4 cleanrooms and above. This ultra clean latex glove is triple washed in deionized water and is supplied with a high-tack finish for applications that require extra grip and traction. Every Blazer lot is tested for endotoxin and has very low levels of detectable protein (less than 50 µg/g).

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

    Isofield Blazer LT

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

    PRODUCT INFO

    • Sterile latex Cleanroom gloves
    • 300mm (12”) length
    • Hand-specific
    • Natural colour
    • Textured palm & fingers
    • Beaded cuff
    • Low endotoxin levels
    • Gamma irradiation, minimum 25kGy
    • Sterility Assurance Level 10-6
    • Protein level less than 50µg/g
    • 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

    10630LT

    Size 6.0 1063060LT
    Size 6.5 1063065LT
    Size 7.0 1063070LT
    Size 7.5 1063075LT
    Size 8.0 1063080LT
    Size 8.5 1063085LT
    Size 9.0 1063090LT
    Size 10.0 10630100LT

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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 6.14 - 7.62kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.34 - 4.82 kg
    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 6.14 - 7.62kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.34 - 4.82kg
    Air Freight Pallet Max Height: 135cm Layers: 4 Cartons: 48
    Sea Freight Pallet Max Height: 165cm Layers: 5 Cartons: 60

    300mm (12″) Sterile latex Cleanroom gloves

    The Isofield Blazer LT 300mm (12″) sterile latex Cleanroom glove with extended cuff offers excellent elbow length protection for GMP Grade A & B, 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 Blazer LT lot is tested for endotoxin and has very low levels of detectable protein (less than 50 µg/g).

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  • Cleanroom overalls and garments with a decorative background
    Cleanroom overalls and garments with a decorative backgroundCleanroom garment kit in a box with a green background

    Isofield 80010

    DATA SHEET
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • Non-sterile coverall with hood and re-sealable zip flap
    • Elasticated hood, waist, wrists, and ankles
    • Optimized body fit for improved comfort
    • 58gsm Microporous polypropylene / polyethylene
    • Low-linting robust fabric
    • Excellent low-hazard liquid spray and fine particulates protection

    • 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 Type 5 (EN ISO 13982-1) Protective Clothing against solid particulates Type 6 (EN 13034) Protective clothing against liquid chemicals

    80010

    SMALL 80010S
    MEDIUM 80010M
    LARGE 80010L
    XLARGE 80010XL
    XXLARGE 80010XXL
    3XLARGE 80010XXXL

    • Shelf Life 
    • Four (4) 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 cleanroom bag,
    • 50 outer bags per carton liner with twist tie,
    • 50 pieces per carton (S-XL)
    • 40 pieces per carton (XXL-XXXL)

    • Cleanroom grade C & D
    • Life Sciences
    • Medical device
    • Automotive

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 11.5 - 13.8kg
    Carton Size W38 L58 H47cm
    Nett Weight  10.2 - 12.5 kg
    Air Freight Pallet Max Height: 109cm Layers: 2 Cartons: 8
    Sea Freight Pallet Max Height: 156cm Layers: 3 Cartons: 12

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 11.5 - 13.8kg
    Carton Size W38 L58 H47cm
    Nett Weight 10.2 - 12.5kg
    Air Freight Pallet Max Height: 109cm Layers: 2 Cartons: 10
    Sea Freight Pallet Max Height: 156cm Layers: 3 Cartons: 15

    Non-sterile Cleanroom coverall with hood

    The Isofield 80010 non-sterile Cleanroom coverall with hood is aseptically folded and anti-static. The low linting, PPE Cat III Type 5/6 certified Isofield 80010 provides an excellent option for ISO Class 4 and 5 environments. The robust microporous material provides solid protection against low-hazard liquid spray and fine particulates.

    , Details
  • Cleanroom garment kit with a decorative background
    Cleanroom overall and garment kit with a decorative backgroundCleanroom garment hood kit with a decorative backgroundCleanroom socks and overboots against a decorative backgroundCleanroom garment kit in a box with a green background

    Isofield Alpha Kits

    DATA SHEET
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • MANDARIN COLLAR COVERALL
    • Two-layer mandarin collar provides secure fit at neck area
    • Zip flap with double-sided tape prevents ingress and egress of particles
    • Low-linting, anti-static fabric suitable for chemo handling
    • Elasticated thumb loops
    • Back elastic to prevent bellows effect
    • HOOD
    • Latex-free enclosed elastic face opening for comfortable fit
    • Extra-long yoke for added protection
    • Three panel hood design to minimize skin exposure
    • OVERBOOTS
    • Extra-long knee height
    • Two-ties for added security
    • Anti-slip PU sole
    • All three items are aseptically folded

    • 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: 2015 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom

    80551

    SMALL 80551S
    MEDIUM 80551M
    LARGE 80551L
    XLARGE 80551XL
    XXLARGE 80551XXL
    3XLARGE 80551XXXL

    • 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 set (hood/coverall/boots) per sealed inner bag
    • 1 inner bag per sealed outer bag
    • 40 outer bags per carton liner with twist tie (S-XXL)
    • 35 sets per carton (3XL)

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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 11.5 - 13.8kg
    Carton Size W38  L58   H47 cm
    Nett Weight 10.2 - 12.5kg
    Air Freight Pallet
    Max height: 109cm
    Layers: 2
    Cartons: 8
    Sea Freight Pallet
    Max height: 156cm
    Layers: 3
    Cartons: 12

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 11.5 - 13.8kg
    Carton Size W38  L58   H47 cm
    Nett Weight 10.2 - 12.5kg
    Air Freight Pallet
    Max height: 109cm
    Layers: 2
    Cartons: 10
    Sea Freight Pallet
    Max height: 156cm
    Layers: 3
    Cartons: 15

    Sterile coverall with mandarin collar, hood & overboots

    The Alpha sterile kit with Hood with integrated mask, Coverall with Mandarin Collar & over boots are aseptically folded, validated sterile, & tested against chemo to ASTM F 739. The anti-static, low-linting materials provide essential protection in Grade A/B environments for all cleanroom activities.

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