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Bioclean-D Sterile Overboots

Bioclean-D Sterile Overboots

Product catalog summary

Product Overview: The BioClean-D™ Sterile Disposable Overboots offer exceptional comfort and protection. They are made from antistatic, low-linting CleanTough™ material and feature a slip-resistant sole with easy tie fastenings.

Specifications:

Material: Antistatic CleanTough™ material & slip-resistant SafeStep™ sole
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
Durable CleanTough™ material
Slip-resistant sole
Tested against permeation standard ASTM D6978-05

Quality Standards:

Manufactured in a facility with ISO 9001:2008 and 89/686/EEC Article 11b certifications
Conforms to Category 3 - Complex Design PPE Directive 89/686/EEC
Tested against EN ISO 13034, EN ISO 14325, EN 1149-1, and ASTM D6978-05 standards
Processed in an NEBB certified ISO Class 4 environment
Sterilized in accordance with ISO 11137-1:2006

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 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
Resistance to Ignition: Pass
Seam Strength: 103.2 N (Class 3)
Surface Resistivity: 1.1 x 10¹⁰Ω

Ordering Information: Universal size, packed as one pair per sealed inner PE bag, 15 inner bags per sealed outer PE bag, five outer bags per lined carton (75 pairs).

Contact Information: For Europe, contact Nitritex Ltd. in the UK. For Asia, email [email protected]. For the Americas, email [email protected].

Catalog excerpts

N^^. pure ■ product • protection Offering exceptional comfort and protection, the single use BioClean-D™ Sterile Disposable Overboots are constructed from antistatic low-linting CleanTough™ material, and feature a slip resistant sole and easy tie fastenings. Antistatic CleanTough™ material & slip- resistant SafeStep™ sole Bound seams with single needle stitching Gamma irradiation • Durable CleanTough™ material • Slip-resistant sole • Tested against permeation standard Billy BiocleanI!l-represents Bioclean's™

Open the catalog to page 1

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...

Open the catalog to page 2

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-BDOB METHOETOPOSIDE PACLITAXEL THIOTEPA TREXATE >480 Size Universal Packing One pair per sealed inner PE bag; 15 inner bags per sealed outer PE bag; five outer bags per lined carton (75 pairs) 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...

Open the catalog to page 3

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