Revolutionary new range of fully integrated HPV solutions for sterility testing

Sterility testing is required during the sterilisation validation process, as well as for routine quality control and
detecting major contamination in a batch. The test environment should be as stringently controlled as an aseptic
processing environment. Sterility testing is an extremely difficult process that must be designed to eliminate
false positive results. False positive results are generally due to laboratory contamination from the testing
environment or technician error.

To meet the challenges of sterility testing, Bioquell has developed a revolutionary new fully integrated hydrogen
peroxide vapour (HPV) solution. 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.

Designed to act as a modular, barrier separation technology (‘closed system’), the Bioquell QUBE provides a
physical separation of operators to the sterility test process. The intelligent modular design principles give users
flexibility in selecting the most suitable configuration for their individual process. This allows users to build the
Bioquell QUBE system to their process requirements (e.g. a single module if space is at a premium, up to a full
3 workstation unit for high volume throughput).

The closed barrier technology also enables the user to apply automated HPV biological decontamination.
Within a single module, a rapid 20 minute bio-decontamination cycle* allows fast and efficient material
transfers. The in-built flexible gassing options also allow the user to bio-decontaminate multiple interfaced
Bioquell QUBE modules or separately bio-decontaminate test material and samples as part of a rapid gassing
transfer process. To help ensure users can maximise working area whilst maintaining aseptic conditions,
samples and waste removal can be made via a transfer hatch or rapid gassing port.