Sterile

  • 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

    Non-sterile Cleanroom coverall with hood

    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.

    , , , Details
  • Cleanroom mask and hood with a decorative background
    Cleanroom mask and hood with a decorative backgroundCleanroom mask and hood in a box with a decorative background

    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.

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

    Isofield Beta 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 WITH INTEGRATED FACEMASK
    • Integrated mask with ties for quick and easy donning
    • 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

    80451

    SMALL 80451S
    MEDIUM 80451M
    LARGE 80451L
    XLARGE 80451XL
    XXLARGE 80451XXL
    3XLARGE 80451XXXL

    • 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 13.31 - 16.76kg
    Carton Size W38  L58   H47 cm
    Nett Weight 10.51 - 13.96kg
    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 13.31 - 16.76kg
    Carton Size W38  L58   H47 cm
    Nett Weight 10.51 - 13.96kg
    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 Beta sterile kit with Hood, Coverall with Mandarin Collar and over boots are aseptically folded, validated sterile, and 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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  • 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).

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  • 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).

    , , , 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
  • Cleanroom Gloves on a person against a decorative background
    Cleanroom gloves with a decorative backgroundCleanroom gloves in a box with a decorative background

    Isofield CR++

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

    PRODUCT INFO

    • Sterile latex Cleanroom gloves
    • 600mm (24”) shoulder length
    • Hand-specific
    • Textured palm and fingers
    • Natural colour
    • 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

    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

    • 1 pair per inner PE wallet,
    • 1 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

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 5.80 - 7.05kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.60 - 4.85kg
    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 5.80 - 7.05kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.60 - 4.85kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

    600mm (24″) Sterile latex Cleanroom gloves – Hand-specific

    The Isofield CR++ 600mm (24″) sterile latex shoulder-length Cleanroom gloves are compatible with GMP Grade A & B and 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 facemask on a decorative background
    cleanroom facemask on a decorative backgroundcleanroom facemask on a decorative backgroundcleanroom goggles on a personPPE/Cleanroom facemask in a box with a decorative background

    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.

    , , , 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 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

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