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Bioclean-D Sterile Coverall with Hood and Integrated Boots

Bioclean-D Sterile Coverall with Hood and Integrated Boots

Product catalog summary

Product Overview
The BioClean-D™ Coverall with Hood and Integrated Boots is a disposable garment designed for exceptional comfort and head-to-toe protection, particularly when handling cytotoxic drugs. It features a front zip with a protective flap, elasticated hood, back, cuffs, and ankles, and includes thumb loops for a secure fit.

Specifications

Material: Antistatic CleanTough™ material
Color: White
Construction: Bound seams with single needle stitching
Characteristics: Antistatic to EN 1149-1, low particulating
Compatibility: ISO Class 4 & EU GMP Grade A
Sterilization: Gamma irradiation

Features

Low-linting & durable CleanTough™ material
Thumb loops for secure hold
Zip with sealable cover
Elasticated hood, back, cuffs, and ankles
Tested against permeation standard ASTM D6978-05

Quality Standards

Manufactured in an ISO 9001:2008 certified facility
Tested against ASTM D6978-05 for cytotoxic drugs
Tested against EN 1149-1 for electrostatic properties
Processed in an NEBB certified ISO Class 4 environment
Sterilized according to ISO 11137-1:2006

Sterilization Details

Method: Gamma irradiation
Minimum Dose: 25kGy
Sterility Assurance Level: 10⁻⁶

Shelf Life & Storage
The coverall has a shelf life of three years from the date of manufacture. It should be stored in a dry, cool place (<40°C) away from direct sunlight and fluorescent light.

Performance Test Results

Abrasion Resistance: 10 to 100 cycles (Class 1)
Flex Cracking Resistance: 5,000 to 15,000 cycles (Class 3)
Trapezoidal Tear Resistance MD: 50.8 N (Class 3)
Trapezoidal Tear Resistance CD: 29.5 N (Class 2)
Tensile Strength MD: 79.3 N (Class 2)
Tensile Strength CD: 59.4 N (Class 1)
Puncture Resistance: 5.9 N (Class 2)
Repellence to Liquids: 30% H2SO4 96.9%, 10% NaOH 98.0%, O-Xylene 94.6%, Butan-1-ol 95.4%
Penetration by Liquids: 0% for all tested chemicals
Inward leakage of aerosols of fine particles: Pass
Resistance to penetration by spray: Pass
Resistance to Ignition: Pass
Seam Strength: 103.2 N (Class 3)
Surface Resistivity: 1.1 x 10¹⁰Ω

Contact Information
For orders and inquiries, contact Nitritex Ltd. in Europe or regional offices in Asia and the Americas.

Ordering Information
The coverall is available in sizes XS to XXXXL, with specific chest and height measurements for each size. Packaging includes one piece per sealed inner PE bag, with 20 outer bags per lined carton (15 pieces for sizes XXXL & XXXXL).

Catalog excerpts

Bioclean-D Sterile Coverall with Hood and Integrated Boots-1

STERILE COVERALL with Hood & Integrated Boots About The BioClean-D™ Coverall with Hood and Integrated Boots is a disposable garment featuring a front zip with protective flap, elasticated hood, back, cuffs and ankles and thumb loops to ensure a secure hold. The BioClean-D Coverall with Hood and Boots provides exceptional comfort and head-to-toe protection, even when handling cytotoxic drugs. Specifications MATERIAL: Antistatic CleanTough™ material COLOUR: White EXCEPTIONAL COMFORT HEAD-TO-TOE PROTECTION ANTISTATIC INTEGRATED OVERBOOTS CONSTRUCTION: Bound seams with single needle stitching CHARACTERISTICS: Antistatic to EN 1149-1 & low particulating COMPATIBILITY: ISO Class 4 & EU GMP Grade A STERILIZATION: Gamma irradiation Features Low-linting & durable CleanTough™ material Thumb loops to ensure a secure hold Zip with sealable cover Elasticated hood, back, cuffs and ankles Tested against permeation standard ASTM D6978-05 Billy Bioclean™ represents Bioclean's™ GMP compatible disposable

Open the catalog to page 1

Bioclean-D Sterile Coverall with Hood and Integrated Boots-2

Quality Standards Manufactured in a facility holding ISO 9001:2008 certification Tested against permeation standard ASTM D6978-05 for cytotoxic drugs Tested against standard EN 1149-1 protective clothing - electrostatic properties Processed in an NEBB certified ISO Class 4 environment Sterilized in accordance with ISO 11137-1:2006 Method: Gamma irradiation Minimum Dose: 25kGy Sterility Assurance Level: 10⁻⁶ Shelf Life & Storage Three (3) years from date of manufacture. Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light. Performance Test Results TEST Abrasion Resistance...

Open the catalog to page 2

Bioclean-D Sterile Coverall with Hood and Integrated Boots-3

CleanTough™ Material - ASTM D6978-05 Test Results Breakthrough detection time (minutes) 2 Breakthrough of the test chemical is deemed to have occurred when the permeation rate has reached 0.01 µg/cm /min DOXO-RUBICIN HYDROCHLORIDE TO ORDER Re-Order S-BDFC-XS S-BDFC-S S-BDFC-M S-BDFC-L S-BDFC-XL S-BDFC-XXL S-BDFC-XXXL S-BDFC-XXXXL METHOETOPOSIDE PACLITAXEL THIOTEPA TREXATE >480 Size XS S M L XL XXL XXXL XXXXL Europe (Headquarters) Nitritex Ltd. Minton Enterprise Park, Oaks Drive, Newmarket, Suffolk, CB8 7YY, United Kingdom T: +44 (0) 1638 663338 F: +44 (0) 1638 668890 E: [email protected] Packing...

Open the catalog to page 3

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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