New Sterility Isolator delivers greater efficiency, increased throughput, and individual customizations

by Suzanne Williams, Manager, Bio/Pharmaceutical Microbiology

Experienced and high quality sterility testing is in demand, and Eurofins BioPharma Product Testing’s Microbiology Team responded to growing client needs by adding a new isolator, a Bioquell Qube to its comprehensive laboratory suite of isolators. The Qube is an aseptic processing workstation with an integrated Hydrogen Peroxide Vapor (HPV) decontamination system.

Performing sterility testing using soft-walled isolators since 1997, the Micro Team chose the Qube because it enables greater efficiency, productivity and increased throughput. The team plans to purchase an additional Qube System in 2021.

The Qube is a modular system that is configurable and allows for individual customization as it can be purchased as a 2-, 4- or 6-glove unit. The system at Lancaster is made up of the following main modules: two Qube Extension Modules (QEXT), two Qube Material Transfer Devices (QMTD) and one Qube Hydrogen Peroxide Vapor Module (QHPV). The external surfaces of client samples and media containers as well as supplies are decontaminated with HPV in the QHPV module prior to transfer into the QEXT modules for testing. Samples and supplies are then moved into the QMTD prior to being placed into incubation.

Installation and Operational Qualification has been performed on the system. In addition, decontamination cycles for the entire empty system as well as the loaded middle module or QHPV have been qualified using biological indicators. Aeration data was acquired to confirm VHP levels inside the isolator were acceptable. Studies were performed to ensure there is no ingress of hydrogen peroxide into representative sample containers at a level that could lead to false negative sterility tests.

Features of The Qube:

• Provides a Grade A/ISO 5 environment
• Uses 35% hydrogen peroxide to produce Vaporized Hydrogen Peroxide (VHP) for surface decontamination
• Construction allows for quick installation New Sterility Isolator delivers greater efficiency, increased throughput, and individual customizations
• Maintains a cascading positive pressure from the test to the transfer modules and then to the ambient environment
• Utilizes a touchscreen display user interface
• HPV technology allows for shorter decontamination cycles which provides the ability to turn around the system in a timely manner and to execute more decontamination cycles daily
• Integrated Steritest Symbio System to perform membrane filtration sterility testing
• Glove Leak Tester which integrates with the system to ensure glove integrity
• Ability to purchase software to operate and control environmental monitoring of the system

The improved efficiency obtained from using the Qube System will allow the Micro Team to perform and report sterility test data to clients within their expected timeframe.

For information about sterility testing or the Qube System, please contact your Project Manager.