Sterile

PRODUCT INFO

Sterile Cleanroom overboots
Extra long — 50cm knee height
Two ties for added security
Anti-slip PU sole
Aseptically folded

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

80761

Size

Universal

SHELF LIFE & STORAGE

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

PACKAGING

1 pair per inner bag,
10 pairs per outer bag,
8 outer bags per carton,
80 pairs per carton

APPLICATION

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	7.8kg
Carton Size	W43 L28 H31cm
Nett Weight	6.0kg
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	7.8kg
Carton Size	W43 L28 H31cm
Nett Weight	6.0kg
Air Freight Pallet	Max Height: 139cm Layers: 4 Cartons: 32
Sea Freight Pallet	Max Height: 170cm Layers: 5 Cartons: 40

Sterile Cleanroom Overboots

The Isofield Vista sterile Cleanroom overboots are 50cm (19.5”) tall and aseptically folded. Providing essential protection for GMP Grade A/B cleanroom applications, these anti-static low-linting overboots are constructed with a non-slip PU sole, two sets of ties for secure fit and have excellent barrier properties.

Cleanroom garment kit with a decorative background

Cleanroom hood kit with a decorative background

Cleanroom socks and overboots against a decorative background

Cleanroom garment kit in a box against a green background

Isofield Beta Kits

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

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

PRODUCT CODE & SIZE

80451

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

SHELF LIFE & STORAGE

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

PACKAGING

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)

APPLICATION

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

LOADING

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

COUNTRY OF ORIGIN

China

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.

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

Cleanroom overall and garment kit with a decorative background

Cleanroom garment hood kit with a decorative background

Cleanroom garment kit in a box with a green background

Isofield Alpha Kits

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

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

PRODUCT CODE & SIZE

80551

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

SHELF LIFE & STORAGE

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

PACKAGING

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)

APPLICATION

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

LOADING

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

COUNTRY OF ORIGIN

China

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.

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

Cleanroom mask and hood with a decorative background

Cleanroom mask and hood in a box with a decorative background

Isofield Atto 230

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

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

PRODUCT CODE & SIZE

60521

Size

Universal

SHELF LIFE & STORAGE

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

PACKAGING

1 piece per sealed inner PE bag,
25 inner bags per sealed outer PE bag,
8 outer bags per lined carton (200 pieces)

APPLICATION

Pharmaceutical product preparation
Cleanroom cleaning
Medical device manufacturing
Blending operations
Handling of active materials
Cleanroom equipment maintenance

LOADING

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

COUNTRY OF ORIGIN

China

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.

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

Cleanroom gloves with a decorative background

Cleanroom gloves in a box with a decorative background

Isofield Blazer LT

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

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

PRODUCT CODE & SIZE

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 & STORAGE

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

PACKAGING

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)

APPLICATION

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

LOADING

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

COUNTRY OF ORIGIN

Malaysia

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).

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

Isofield Blazer

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

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

PRODUCT CODE & SIZE

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 & STORAGE

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

PACKAGING

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)

APPLICATION

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

LOADING

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

COUNTRY OF ORIGIN

Malaysia

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).

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

Cleanroom Facemask from the side with a decorative background

Cleanroom Facemask from the rear with a decorative background

Cleanroom facemask in a box with a decorative background

Isofield Tera 230

PRODUCT INFO

Validated sterile tie-on Cleanroom facemask
230mm length with a malleable nose strip, providing a secure fit and full face coverage
3-layer non-woven configuration
Highly efficient bacterial and particle filtration
Gamma irradiation, minimum 25kGy
Sterility Assurance Level 10^-6
Particle Shedding (Helmke Drum) Category I
IPA resistant ink pouches to maintain traceability

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

Processed in a NEBB Certified ISO Class 5 environment Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

PRODUCT CODE & SIZE

60131

Size

Universal

SHELF LIFE & STORAGE

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

PACKAGING

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

APPLICATION

Loading vials into a sterile lyophilizer
Aseptic filling, sealing, transfer of stoppered vials
Blending granulates and powders

LOADING

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

COUNTRY OF ORIGIN

China

Validated sterile tie-on Cleanroom facemask, 230mm width

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

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

cleanroom facemask on a decorative background

PPE/Cleanroom facemask in a box with a decorative background

Isofield Exa 230

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

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

PRODUCT CODE & SIZE

60011

Size

Universal

SHELF LIFE & STORAGE

- 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

PACKAGING

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)

APPLICATION

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

LOADING

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

COUNTRY OF ORIGIN

China

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.

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

Isofield Steridon

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

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

PRODUCT CODE & SIZE

80111

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

SHELF LIFE & STORAGE

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

PACKAGING

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)

APPLICATION

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

LOADING

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

COUNTRY OF ORIGIN

Malaysia

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.

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

Cleanroom Coverall garment with facemask kit

Isofield Steridon with Integrated Facemask

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

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

PRODUCT CODE & SIZE

80231

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

SHELF LIFE & STORAGE

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

PACKAGING

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)

APPLICATION

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

LOADING

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

COUNTRY OF ORIGIN

Malaysia

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.

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

person wearing cleanroom gloves on a decorative background

Cleanroom gloves on a decorative background

Cleanroom Sterile nitrile gloves in a box

Isofield Eclipse

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

CLEANROOM COMPATIBILITY

GMP Grade A cleanroom
GMP Grade B cleanroom
ISO Class 4 cleanroom
ISO Class 5 cleanroom
Class 10 cleanroom
Class 100 cleanroom

QUALITY ASSURANCE

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

PRODUCT CODE & SIZE

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 & STORAGE

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

PACKAGING

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)

APPLICATION

Aseptic assembly of filling equipment
Filtration, filling, stoppering and capping of vials
Aseptic compounding and mixing
Staging and conveying of sterile primary packaging components

LOADING

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

COUNTRY OF ORIGIN

Malaysia

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.

GMP Grade A, GMP Grade B, ISO Class 4, ISO Class 5 Details

Isofield Volta