Recent trends in gene therapies and personalised medicines have driven the need for the preperation 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.
To meet the challenges seen in aseptic processing, Bioquell has developed a fully integrated hydrogen peroxide vapour (HPV) workstation, the Bioquell QUBE. It offers a rapid, validated 6-log sporicidal decontamination capability that maintains an EU grade A/ISO 5 quality environment. This HPV technology has been shown to reduce finger dab contamination assessment failure rates to less than 0.1%. The Bioquell QUBE also offers 3 different levels of integrated environmental monitoring including viable and continuous particle monitoring to ensure process rigour and good documentation.
The intelligent, modular design of the Bioquell QUBE provides flexibility for the user to configure the system to fit a number of different processes including batch production and individual patient prescriptions. Separate 2-glove modules can be combined to give a system which best suits to the users current process requirements but can be easily expanded to meet future needs. The closed barrier technology also allows the user to apply HPV bio-decontamination in one module whilst aseptic processing is carried out in another.
Bioquell QUBE with extension module and material transfer device.
Bioquell technology can also be employed in many existing isolators to reduce risks of bio-contamination during aseptic services. By applying HPV gassing, decontamination GMP Annex 1 can be routinely maintained reducing risks to patient safety.
Along with biological contamination another major risk to patient safety in the compounding process is prescription errors. For this reason Bioquell have developed a cage and tray solution. This allows multiple patient prescriptions to be present in the chamber for compounding, attached to the associated worksheet, whilst remaining separated therefore reducing the risk of mix up. The trays have been optimized for use with HPV by minimizing the contact area of the components with the cage whilst allowing for ideal gas distribution. The use of this system will allow the user to increase throughput whilst ensuring continued patient safety.
The user has the option to attach a Bioquell HPV-CI to each prescription cage. Under successful HPV bio-decontamination conditions, this HPV-CI shows a clear colour change. This can be labeled or attached to the worksheet and provide a permanent record that prescription components have been exposed to HPV bio-decontamination conditions.
Can Bioquell provide me a range of options for aseptic control and management?
Bioquell are able to provide complete aseptic processing solutions for hospital pharmacies incorporating Bioquell’s unique HPV process which ensures compliance with bio-contamination levels required by international regulatory bodies. Bioquell are recognised experts in aseptic process and ensure that, following a detailed process review, an efficient aseptic processing system is designed to meet the increased demands on hospital pharmacy operations. With the emerging need to provide personalised treatments, it is critical to work alongside solution providers who are able to understand the processes both now and in the future. Bioquell have strong experience in providing regulatory compliant solutions and work alongside pharmacies from initial process definition through to regulatory approval and into operation.
Considerations for an ideal hospital aseptic pharmacy
An article that covers the key considerations for an ideal hospital aseptic pharmacy has been published on the Hospital Pharmacy Europe website. Click on the link below for more information (registration required)
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