Sterility testing is required during the sterilization validation process, as well as for routine quality control and detecting major contamination in a batch.
Recent trends in gene therapies and personalised medicines have driven the need for the preparation of individual patient prescriptions, often having short shelf life. As this is mostly an aseptic production process, bio-contamination control is essential in order to reduce the risk to patients.
Traditional disinfection methods rely on a manual spray and wipe process using alcohols or other cleaning wipes. These processes can compromise the bio-decontamination control due to a number of factors such as cleaning agent contact time, incomplete coverage of exposed areas and ineffectiveness against some biological material (e.g. spores). Failure rates of 3–4% from finger dab contamination assessments are not uncommon. Each failure will involve lengthy investigations and may result in the scrapping of costly batches of product, or worse, patient infection.
Bioquell’s HPV technology provides a rapid and repeatable way of decontaminating portable medical equipment, especially sensitive electronics, which are often identified as a significant challenge for hospitals.
The bio-decontamination of medical equipment that has been compromised by nosocomial pathogens is of key importance - Bioquell's hydrogen peroxide vapour decontamination system is able to eliminate HCAI from all exposed surfaces and high touch sites, without affecting either the performance or aesthetics of the equipment.