Applications

Sterility testing

Sterility testing is required during the sterilization 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.

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 hydrogen peroxide vapor (HPV) decontamination technology.

This 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 aseptic environment.

Often it is the end user who is required to integrate the all components required to create a complete sterility test solution. Bioquell expertise in aseptic process allow us to work alongside the end user to select the most appropriate components and integrate into a complete sterility test solution.
 

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Our Solutions

To meet the challenges of sterility testing, Bioquell has developed a revolutionary new fully integrated hydrogen peroxide vapor (HPV) solution. The Bioquell QUBE offers a rapid sporicidal bio-decontamination process with a high level validated 6-log reduction in bioburden. This 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 units 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 built-in 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 maximize working area while maintaining aseptic conditions, samples and waste removal can be made via a transfer hatch or rapid gassing port.

* When using a single unit and depends on loading and absorbency of chamber contents.

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  • Causes and effect of false positives and false negatives in sterility testing.

     This paper reviews the background to false postitives and false negatives associated with the sterility test process.  It explores the potential causes of such results and suggests methods of mitigation.  It also includes insight into the role of hydrogen peroxide vapor bio-decontamination technology can have on false positives and false negatives while indicating how this technology can also be used to eliminate them.

  • Bioquell QUBE - Steritest Workstation

    Revolutionary new range of fully integrated HPV solutions for sterility testing

    Sterility testing is required during the sterilization 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 diffi cult 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.

     

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