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Bioclean-D Sterile Coverall with Collar

Bioclean-D Sterile Coverall with Collar

Bioclean-D Sterile Coverall with Collar

Product catalog summary
Product Overview
The BioClean-D™ Coverall with Collar is a single-use disposable garment designed for exceptional comfort and protection, particularly when handling cytotoxic drugs. It features a front zip with a protective flap, elasticated back, cuffs, ankles, and thumb loops for a secure fit.

Specifications
  • Material: Antistatic CleanTough™ material
  • Color: White
  • Construction: Bound seams with single needle stitching
  • Classification: PPE Cat 3 Type 5 & 6
  • 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 back, cuffs, and ankles
  • Tested against permeation standard ASTM D6978-05

Quality Standards
The coverall is manufactured in a facility with ISO 9001:2008 and 89/686/EEC Article 11b certifications. It conforms to Category 3 - Complex Design Personal Protective Equipment PPE Directive 89/686/EEC and is tested against various standards for protective clothing and chemical resistance.

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

Shelf Life
Three years from the date of manufacture.

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: CD 29.5 N (Class 2), MD 50.8 N (Class 3)
  • Tensile Strength: CD 59.4 N (Class 1), MD 79.3 N (Class 2)
  • Puncture Resistance: 5.9N (Class 2)
  • Repellence to Liquids: 30% H2SO4 96.9% (Class 3), 10% NaOH 98.0% (Class 3), O-Xylene 94.6% (Class 2), Butan-1-ol 95.4% (Class 3)
  • Penetration by Liquids: 0% for all tested chemicals (Class 3)
  • Inward leakage of aerosols: 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.

Packing
One piece per sealed inner PE bag; 20 outer bags per lined carton (20 pieces). Sizes XXXL & XXXXL have 15 pieces per carton.

CleanTough™ Material - ASTM D6978-05 Test Results
Breakthrough detection time for various chemicals is greater than 480 minutes, indicating high resistance.
See more

Catalog excerpts

Bioclean-D Sterile Coverall with Collar-1

N^^. pure ■ product • protection The BioClean-D™ Coverall with Collar is a single use disposable garment featuring a front zip with protective flap, elasticated back, cuffs and ankles and thumb loops to ensure a secure hold. The BioClean-D Coverall provides exceptional comfort and protection, even when handling cytotoxic Antistatic CleanTough™ material Bound seams with single needle stitching Gamma irradiation • Low-linting & durable CleanTough™ • Thumb loops to ensure a secure hold • Zip with sealable cover • Elasticated back, cuffs and ankles • Tested against permeation standard STERILE COVERALL with Collar Billy Bioclean™ represents Bioclean's™

 Open the catalog to page 1
Bioclean-D Sterile Coverall with Collar-2

Quality Standards Manufactured in a facility holding ISO 9001:2008 and 89/686/EEC Article 11b certifications Conforms to Category 3 - Complex Design Personal Protective Equipment PPE Directive 89/686/EEC Tested against standard EN ISO 13982-1 protective clothing for use against solid particles (Type 5) Tested against standard EN ISO 13034 protective clothing against liquid chemicals (Type 6) Tested against standard EN ISO 14325 protective clothing against chemicals Tested against permeation standard ASTM D6978-05 for cytotoxic drugs Tested against standard EN 1149-1 protective clothing - electrostatic...

 Open the catalog to page 2
Bioclean-D Sterile Coverall with Collar-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-BDCCT-S S-BDCCT-M S-BDCCT-L S-BDCCT-XL S-BDCCT-XXL S-BDCCT-XXXL S-BDCCT-XXXXL METHOETOPOSIDE PACLITAXEL THIOTEPA TREXATE >480 Size S M L XL XXL XXXL XXXXL Packing One piece per sealed inner PE bag; one inner bag per sealed outer PE bag; 20 outer bags per lined carton (20 pieces). Please note: sizes XXXL & XXXXL 15 pieces per carton. Europe (Headquarters)...

 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.