To meet the challenges of sterility testing, a revolutionary new fully integrated hydrogen peroxide vapour (HPV) workstation called the Bioquell QUBE has been launched at ACHEMA 2012.
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.
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 Millipore Steritest system.
Developed as a modular, barrier separation system, the Bioquell QUBE provides a physical separation of operators from 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 an individual processes. If space is limited, a single module can be installed, but where there is a need for high volume throughput, a three chamber workstation can be implemented.
‘Modern technology has to meet the challenges of modern processing and the new Bioquell QUBE has been designed to do just that,’ said Dr Tim Flanagan, head of life sciences at Bioquell. 'It enables you to expand with your process by simply adding modules, while its rapid bio-decontamination cycle gives fast batch turnaround.’
