Specifically designed to meet the stringent requirements of a pharmaceutical barrier system, the Bioclean BarrierPlus range sets a new standard for cleanliness and quality assurance
BioClean BarrierPlus gauntlet being visually inspected before being immersed in water for three minutes, during the air leak test
UK-based Nitritex has launched a range of isolator and Restricted Access Barrier Systems (RABS) sleeves and gauntlets, suitable for use in highly controlled environments. Specifically designed to meet the stringent requirements of a pharmaceutical barrier system, the Bioclean BarrierPlus range sets a new standard for cleanliness and quality assurance, the company says.
Processed in an ISO Class 4 cleanroom, BioClean BarrierPlus gauntlets and sleeves have extremely low levels of particulates and are packed in cleanroom compatible packaging. Manufactured from white-coloured accelerator-free nitrile, they are resistant to a wide range of chemicals including a selection of commonly used chemotherapy drugs. Nitrile also exhibits excellent ESD (Electrostatic Dissipative) properties.
It is widely accepted that isolator gauntlets and sleeves are the weakest point of any barrier system: Nitritex’s manufacturing process has five separate product inspections throughout. Each gauntlet is visually inspected 100% for holes, along with water and air pressure testing, to guarantee delivery of a gauntlet free from holes. Before the ends are guillotined, sleeves are subjected to exactly the same testing.
BioClean BarrierPlus Sterile Gauntlets are available in lengths of up to 840mm (33 inches) and three port sizes from 150mm to 300mm (6ins to 12ins). BioClean BarrierPlus Sterile Sleeves are available in lengths of up to 660mm (26ins), and suitable for port sizes from 150mm (6ins) to 300mm (12ins). With a cuff ring diameter of 90mm (3.5ins) the sleeves will fit the majority of available cuff ring systems.
Alternatively, for a complete sleeve assembly Nitritex can provide a compatible cuff ring with a sterile glove. 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.
Uniquely designed for RABS, where interventions are rare and access speed is critical, BioClean BarrierPlus Mittens are a cost effective alternative to gauntlets. Mittens are available in lengths of up to 840mm (33ins) and suitable for port sizes from 230mm (9ins) to 265mm (10.5ins).
Designed for use in product contact areas, all BarrierPlus gauntlets and sleeves are fully validated for sterility with an SAL (Sterility Assurance Level) of 10-6 and triple packed in non-particulating packaging for ease of entry into the cleanroom environment. Nitritex’s EasyTear packaging makes them easy to open even while wearing gloves.
The complete range satisfies Category 3 - Complex Design PPE (Personal Protective Equipment) conforming to PPE Directive 89/686/EEC, is 100% inspected prior to packing in an ISO Class 4 cleanroom and comes pre-sterilised by gamma irradiation. 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.