Leading cleanroom glove manufacturer Nitritex has expanded its Bioclean range to include isolator and restricted access barrier system (RABS) sleeves and gauntlets manufactured from white-coloured accelerator-free nitrile (a stretchy, chemical-resistant synthetic rubber).
Experts in cleanroom glove design and manufacture for more than 18 years, Nitritex has used this experience and expertise to create a range of sleeves and gauntlets specifically designed for pharmaceutical and life science use.
From a contamination standpoint, one of the weakest links in an isolator system is the sleeve or gauntlet. It is standard for sophisticated leak tests to be carried out before each session of use to ensure that the isolator remains leak-tight and uncompromised. It is a major advantage if the sleeve/gauntlet being supplied is already 100% leak tested to provide the first level of assurance that it can be placed directly onto the isolator system. It also needs to be sterile to meet the requirements of cGMP and exhibit very low levels of particulate shedding (usually in reference to IEST-RP-CC005-3) to maintain the cleanliness requirements of Grade A and B product contact zones.
Historically, gauntlets were developed for the nuclear and containment industry and consideration was not always given to life science requirements. The BioClean range of sleeves and gauntlets has been designed specifically for the life science industry and the facility in which the products are manufactured and processed has been developed with these stringent requirements in mind.
Processed in a controlled environment to remove particles and ionic content and then packed in an ISO Class 4 cleanroom, BioClean BarrierPlus sleeves and gauntlets are triple bagged in linear tear packaging which is particulate free, and easy to open even while wearing gloves. The bagged products are then packed in polyethylene boxes, which further reduce the risk of any particulates being generated, before undergoing sterilisation via gamma irradiation which guarantees an SAL (Sterility Assurance Level) of 10¯⁶.
BioClean sleeves and gauntlets have quality built in. The production process includes five separate inspections of the product throughout the manufacturing process. Each sleeve or gauntlet is 100% inspected for holes, first visually and subsequently using a water and air pressure test, guaranteeing that a leak tight sleeve or gauntlet is delivered. This is achieved by the gauntlet or sleeve (prior to the end being guillotined) being filled with air to a specified pressure and submerged under water for three minutes. The water is checked for any bubbles identifying whether the product has a pinhole leak.
A further 100% inspection and air tight test is also carried out before the dried product is packed
This 100% inspection is more rigorous than the AQL approach for surgical gloves which is based on a statistical sampling plan. Only if the product passes this test is it sent for final processing and packing in an ISO Class 4 cleanroom. A further 100% inspection and air tight test is also carried out before the dried product is packed.
The BarrierPlus range includes the following configurations:
BioClean BarrierPlus Sterile Gauntlets are available in lengths of up to 840mm (33”) and three port sizes from 150mm to 300mm (6.0” to 12”).
BioClean BarrierPlus Sterile Sleeves are available in lengths of up to 660mm (26”), and suitable for port sizes from 150mm (6.0”) 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.
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 (33”) and suitable for port sizes from 230mm (9”) to 265mm (10.5”). 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.
