BioClean BarrierPlus™Sterile Sleeve & Gauntlet Range

Richard Bryant

Nitritex Ltd are in complete control of the manufacturing

process…

Dipping & Drying

Quality Testing

PackingWashing &

Drying

Flow Diagram of Production Process for Nitrile

BioClean BarrierPlus™ Features

· ISO Class 4 compatible

· Low levels of particulates

· Accelerator-free nitrile

· Excellent ESD properties

· Cat 3 - Complex Design PPE

· Chemical resistant including a selection of commonly-used chemotherapy drugs

· Cleanroom compatible EasyTear™ packaging

BioClean BarrierPlus™ Features

· Each gauntlet visually inspected on five separate occasions

· Each gauntlet is subjected to water and air pressure testing

· Each gauntlet is 100% free from pinholes

BioClean BarrierPlus™ Features

· Washed in deionised water to remove any particles

· Dried in a ISO Class 4 controlled environment

BioClean BarrierPlus™ Features

· Packed in an ISO Class 4 cleanroom

· 100% inspected and air tight test before packing

· Fully validated SAL 10-6

· Triple bagged

BioClean BarrierPlus™ Features

· Packed in a white polyethylene Correx box

· Two Correx boxes per carton

· Reduces the risk of any particulates being generated

Sterile Gauntlets – S-BBNG

· Available in lengths of up to 840mm (33”)

· To fit port sizes from 150mm to 300mm (6.0” to 12”)

Sterile Sleeves – S-BBNS0

· Available in lengths of up to 660mm (26”)

· To fit port sizes from 150mm to 300mm (6.0” to 12”)

· Cuff ring diameter of 90mm (3.5”)

· Sleeves will fit the majority of available cuff ring systems

Sterile Mittens – S-BBNM

· Uniquely designed for RABS, where interventions are rare and access speed is critical

· Cost effective alternative to gauntlets

· Available in lengths of up to 840mm (33”)

· To fit port sizes from 230mm to 265mm (9” to 10.5”)

Frequently Asked Questions…

·Are they single use or reusable?

Can be single use or reusable depending on the end-users SOP

·If reusable, how many times can they be reused?

Depends on the SOP and chemicals used, and the sanitizing process

·Can the Nitrile S-BBNG be autoclaved?

Yes. We have successfully run 15 cycles at 121º for 30 min intervals

·Are they compatible with VHP?

Yes. How many exposures depends on end users unique H2O2 protocol

·Are the S-BBNG, S-BBNM, S-BBNS0 available in non-sterile?

Yes however; non-sterile would reduce price only marginally so we recommend taking the sterile as the default option

Key Features & Benefits

BarrierPlus™ products are:

·Packed for use EU GMP Grade A areas

·Fully validated for sterility

·ISO Class 4 processed & packed

·Extensively tested against chemo drugs (ASTM D6978-05 standard)

·Batch Particle Testing for all BarrierPlus™ products

·Can be order in small quantities and have them shipped with other BioClean™ quality branded products

ASTM D6978-05 Test Results

LPC Batch Test Results

EN 388 Test Results

Full Sterility Validation

Thank you for your attention