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Bioclean-D Sterile Hood

Bioclean-D Sterile Hood

Product catalog summary

Product Overview
The BioClean-D™ Hood is a sterile, single-use hood designed for optimal fit and comfort. It is made from antistatic, low-linting CleanTough™ material and features an elasticated face-opening with reinforced edges.

Specifications

Material: Antistatic CleanTough™
Color: White
Construction: Bound seams with single needle stitching
Classification: PPE Cat 3 Type PB [6]
Characteristics: Antistatic to EN1149-1 & low particulating
Compatibility: ISO Class 4 & EU GMP Grade A
Sterilization: Gamma irradiation

Features

Low-linting and durable material
Tested against ASTM D6978-05 for permeation
Three-piece design

Quality Standards

Manufactured in ISO 9001:2008 certified facility
Conforms to PPE Directive 89/686/EEC
Tested against EN ISO 13034, EN ISO 14325, EN 1149-1
Processed in NEBB certified ISO Class 4 environment
Sterilized according to ISO 11137-1:2006

Sterilization

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

Shelf Life & Storage

Three years from manufacture date
Store 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), CD 29.5 N (Class 2)
Tensile Strength: CD 59.4 N (Class 1), MD 79.3 N (Class 2)
Puncture Resistance: 5.9 N (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)
Resistance to Ignition: Pass
Seam Strength: 103.2 N (Class 3)
Surface Resistivity: 1.1 x 10¹⁰Ω

Ordering Information

Re-Order Code: S-BDHD
Size: Universal
Packing: One piece per sealed inner PE bag; 30 inner bags per sealed outer PE bag; six outer bags per lined carton (180 pieces)

Contact Information

Europe (Headquarters): Nitritex Ltd., Newmarket, Suffolk, UK
Asia: [email protected]
Americas: [email protected]

CleanTough™ Material - ASTM D6978-05 Test Results

Breakthrough detection time for various chemicals: >480 minutes

Catalog excerpts

N^^. pure ■ product • protection The BioClean-D™ Hood is a sterile single use hood designed and constructed using three sections for a perfect fit. Made from antistatic durable low-linting CleanTough™ material, the hood features an elasticated face-opening with reinforced edges for exceptional comfort Antistatic CleanTough™ material Bound seams with single needle stitching Gamma irradiation • Durable CleanTough™ material • Tested against permeation standa THREE PIECE DESIGN Billy Bioclean™ represents Bioclean's™

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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 13034 protective clothing against liquid chemicals (Type PB[6]) Tested against standard EN ISO 14325 protective clothing against chemicals Tested against standard EN 1149-1 protective clothing - electrostatic properties Tested against permeation standard ASTM D6978-05 for cytotoxic drugs Processed in an NEBB certified ISO Class 4 environment Sterilized in accordance...

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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-BDHD METHOETOPOSIDE PACLITAXEL THIOTEPA TREXATE >480 Size Universal Packing One piece per sealed inner PE bag; 30 inner bags per sealed outer PE bag; six outer bags per lined carton (180 pieces) Europe (Headquarters) Nitritex Ltd. Minton Enterprise Park, Oaks Drive, Newmarket, Suffolk, CB8 7YY, United Kingdom T: +44 (0) 1638 663338 F: +44 (0) 1638...

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