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A hydrogen peroxide vapour (HPV) sterility testing workstation has been launched at the ACHEMA event in Frankfurt.
The Bioquell QUBE was developed to meet the ongoing challenge of sterility testing and launched this week at the ACHEMA Congress on Chemical Engineering, Environmental Protection and Biotechnology.
Using the latest manufacturing techniques and materials, the Bioquell QUBE offers a rapid sporicidal bio-decontamination process with a high-level validated 6-log reduction in bioburden.
This in-built bio-decontamination system has been designed to complement a fully fitted and validated sterility test unit such as the market leading Millipore Steritest system.
Developed as a modular, barrier separation system, the Bioquell QUBE provides a physical separation of operators to the sterility test process.
The closed barrier technology enables the user to apply the automated HPV biological decontamination. Within a single module, a rapid 20 minute bio-decontamination cycle allows fast and efficient transfers.
An EU GMP Grade A / ISO 5 compliant environment is ensured by both uni-directional airflow and unique isolator technology.
The intelligent modular design gives users flexibility in selecting the most suitable configuration for their individual processes. If space is limited, a single module can be installed whilst, where there is a need for high volume throughput, a three chamber workstation can be implemented.
Commenting on the launch, Dr Tim Flanagan, Head of Life Sciences at Bioquell said, “Modern technology has to meet the challenges of modern processing and our new Bioquell QUBE has been designed to do just that. It enables you to expand with your process by simply adding modules whilst its rapid bio-decontamination cycle gives fast batch turnaround. And all of this is backed by Bioquell’s unmatched experience in bio-decontamination technology, developed over the last 200 years.”
Sterility testing is required during the sterilisation validation processes as well as for routine
control and detecting major contamination in a batch of sterile product.
The Bioquell QUBE will help to ensure that the aseptic test environment is stringently controlled to eliminate false positive results.