Bio-Decontamination Of Sterility Testing Systems

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 important process that must be designed to eliminate false positive results. False positive results are generally due to laboratory contamination from the testing environment or technical error in sample preparation.

Bioquell has over 10 years experience in providing integrated solutions for sterility testing. Our latest product, the Bioquell QUBE is an aseptic work station equipped with appropriate environmental monitoring systems, sterility test system and Bioquell’s unique HPV decontamination technology.

As part of a rigorous process, the Bioquell QUBE ensures that an aseptic environment is maintained and material movements in, and out, of the aseptic work zone are efficient and do not compromise the test process.

Bioquell expertise in decontamination technology, aseptic environments and process workflows allow us to work alongside the end user to select the most appropriate components and integrate into a complete sterility test solution.

To meet the challenges of sterility testing, Bioquell has developed a revolutionary new fully integrated aseptic processing work station. 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 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 module workstation for high volume throughput). The closed barrier technology also enables the user to apply automated HPV biological decontamination. Within a single module, a rapid  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 material transfer device.