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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 and sterility test validation. Our latest product, the Bioquell QUBE for sterility testing is an aseptic work station equipped with appropriate environmental monitoring systems, sterility test system and Bioquell’s unique hydrogen peroxide vapour (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.

Bioquell products in sterility testing

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