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BioClean Drop Down Garment

BioClean Drop Down Garment

BioClean Drop Down Garment

Product catalog summary
Overview: The BioClean-D™ Drop-down Garment with Hood is a sterile, antistatic, disposable garment made from low-linting, durable CleanTough™ material. It features a unique aseptic gowning technique with internal colored tabs for safe touch points, an innovative donning design to prevent floor contact, and quick-release tabs for aseptic donning.
Specifications:
  • Material: CleanTough™
  • 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:
  • Elasticated back, hood, cuffs, and ankles
  • Foot-loop for smooth zip closure
  • Quick release press stud tabs
  • Low-linting & durable material
  • Tested against ASTM D6978-05 for cytotoxic drugs
Quality Standards:
  • Manufactured in ISO 9001:2008 certified facility
  • Processed in NEBB certified ISO Class 4 environment
  • Sterilized per 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; CD 29.5 N, Class 2
  • Tensile Strength: MD 79.3 N, Class 2; CD 59.4 N, Class 1
  • 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
  • Inward leakage of aerosols: Pass
  • Resistance to Ignition: Pass
  • Seam Strength: 103.2 N, Class 3
  • Surface Resistivity: 1.1 x 1010Ω
Contact Information:
Ordering Information: Available in sizes XS to XXXXL, packed one piece per sealed inner PE bag, 20 pieces per carton (15 for larger sizes).
Patent: BeMicron Patent #EP2303044B1
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Catalog excerpts

BioClean Drop Down Garment-1

DROP-DOWN Sterile Garment with Hood About The BioClean-D™ Drop-down Garment with Hood is a sterile antistatic disposable garment manufactured from low-linting durable CleanTough™ material. It’s unique design offers the world’s first true aseptic gowning technique. With internal coloured tabs to indicate safe touch points to prevent touching the outside surface, innovative up and over donning design to eliminate the risk of the garment touching the floor, strategically placed quick release tabs to hold and remove during zip closure and removable zip tab to complete and ensure aseptic donning. Specifications MATERIAL: CleanTough™ material EXCEPTIONAL COMFORT AND PROTECTION ANTISTATIC & LOWLINTING UNIQUE UP AND OVER DESIGN ASPECTIC DONNING TECHNIQUE COLOUR: 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 Elasticated back, hood, cuffs and ankles Foot-loop to aid smooth closure of zip Quick release press stud tabs for aseptic donning Low-linting & durable CleanTough™ material Tested against permeation standard ASTM D6978-05 Billy Bioclean™ represents Bioclean's™ GMP compatible disp

 Open the catalog to page 1
BioClean Drop Down Garment-2

Quality Standards Manufactured in a facility holding ISO 9001:2008 Tested against permeation standard ASTM D6978-05 for cytotoxic drugs 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 Three (3) years from date of manufacture Performance Test Results PERFORMANCE CLASS Abrasion Resistance Flex Cracking Resistance Trapezoidal Tear Resistance Trapezoidal Tear Resistance Tensile Strength Tensile Strength Puncture Resistance Inward leakage of aerosols of fine...

 Open the catalog to page 2
BioClean Drop Down Garment-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-BDSH-XS S-BDSH-S S-BDSH-M S-BDSH-L S-BDSH-XL S-BDSH-XXL S-BDSH-XXXL S-BDSH-XXXXL METHOETOPOSIDE PACLITAXEL THIOTEPA TREXATE >480 Size X-Small Small Medium Large X-Large XX-Large XXX-Large XXXX-Large Europe (Headquarters) Nitritex Ltd. Minton Enterprise Park, Oaks Drive, Newmarket, Suffolk, CB8 7YY United Kingdom T: +44 (0) 1638 663338 F: +44 (0)...

 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.