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BioClean BarrierPlus™ Isolator Sleeve

BioClean BarrierPlus™ Isolator Sleeve – Each

THE NEW STANDARD FOR ISOLATOR & RABS SLEEVES

Description

The S-BBNS0 is available in lengths of up to 660mm (26”), and suitable for port sizes from 150mm (6.0”) to 300mm (12”). With a cuff ring diameter of 90mm (3.5”) the sleeves will fit the majority of available cuff ring systems. Alternatively, a compatible cuff ring with a sterile glove already fitted can be provided, for a complete sleeve assembly. The use of a sleeve system ensures that each operator can wear a pair of the correct sized gloves to aid dexterity and reduce fatigue. BarrierPlus sleeves are ISO Class 4 and EU GMP Grade A compatible, have incredibly low levels of particles (tested in accordance with IEST-RP-CC-005.3) and also exhibit excellent ESD (Electrostatic Dissipative) properties. Fully validated for sterility with an SAL (Sterility Assurance Level) of 10-6, each piece is triple bagged in non-particulating ISO Class 4 compatible EasyTear™ packaging, ensuring suitability for even the most stringent of SOP’s. BioClean BarrierPlus™ sleeves are 100% inspected during processing and packing, and have been tested against ASTM D6978-05 for handling chemotherapy drugs. If required, the BioClean BarrierPlus range can be autoclaved, wiped down with IPA (Isopropyl Alcohol) and is suitable for use with vaporised hydrogen peroxide (H2O2) gassing isolator systems.

Colour

White

Other Features

May be sanitized with VHP or IPA and suitable for autoclaving

Material

Nitrile

Type

Sleeve. Suitable for port sizes 150mm – 300mm (6″ to 12″)

Length

660mm (26″)

Surface

Smooth

Protein Level

Nitrile contains no natural latex proteins

Packing

Bagged

Particulates

Tested according to IEST-RP-CC-005.3

Physical Properties

Complies with the requirements of ASTM D6978-05 tested against cytotoxic drugs

Powdered

Powder-free

Sterile

Sterile

Quality Systems

Manufactured in a facility holding ISO 9001:2008 and 89/686/EEC Article 11b certifications. Processed in an NEBB certified ISO Class 4 cleanroom environment

Sampling & Inspection

100% inspection and air leak tested

Storage Instructions

Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent lighting

Shelf Life

Three (3) years from date of manufacture

Lot Number

This is shown on the sealed pouch and the carton to provide product traceability

Notes

Cuff ring system available on request, with a choice of sterile, ISO Class 4 compatible 300mm (12″) gloves.

Compatibility

ISO Class 4 & EU GMP Grade A

Regulatory Classification

Category 3 – Complex Design Personal Protective Equipment conforming to PPE Directive 89/686/EEC Click here to visit the category homepage