White Papers

Variability in sterility test processes and the benefits of modular workstations

James Drinkwater, Bioquell UK Process & Compliance Director.
Chairman PHSS – Pharmaceutical & Healthcare Sciences Society.

This paper reviews some of the current operational practices that incorporate sterility testing and provides an insight into the role of hydrogen peroxide vapour bio-decontamination and continuous particle monitoring.

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Bio-decontamination processes compared: hydrogen peroxide vapour and chlorine dioxide

When reviewing the best method of bio-decontamination to apply for any given application, it should be considered on its merit in a number of areas such as safety, efficacy, ease of use and compatibility. Due to those factors, using formaldehyde (one of the older bio-decontamination methods) is becoming increasingly rare as safer methods are sought. Copious data exists for a number of alternative methods of bio-decontamination; this paper reviews the available information and compares/contrasts two of the more widely implemented methods, hydrogen peroxide vapour (HPV) and chlorine dioxide (CD).

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Biological indicators for hydrogen peroxide vapour technology

Dr Lynne Murdoch, Bioquell UK Ltd

Biological indicators (BIs) have become the industry standard for verification of hydrogen peroxide vapour (HPV) decontamination efficacy. This white paper discusses BIs for use with HPV and some of the factors associated with inconsistent performance of BIs used to assess HPV bio-decontamination cycles.

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Flexibility in sterility testing and managing risks of false positives

James Drinkwater, Bioquell UK Process & Compliance Director.
Chairman PHSS – Pharmaceutical & Healthcare Sciences Society.

This paper reviews the background to false positives 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 an insight into the role hydrogen peroxide vapour bio-decontamination technology can have on false positives and false negatives whilst indicating how this technology can also be used to eliminate them.

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The need to improve hospital hygiene in order to reduce transmission

Jon A. Otter, PhD, Scientific Director, Healthcare, Bioquell UK Ltd.

Recent data provide compelling evidence that contaminated surfaces are an important factor in the cross-transmission of pathogens causing some healthcare associated infections, for example, Clostridium difficile, Acinetobacter baumannii and norovirus. This white paper summarises the data and reviews evidence that nosocomial pathogens are shed by patients, can contaminate hospital surfaces, can survive for extended periods, can persist despite attempts to disinfect or remove them and can be transferred to the hands of healthcare workers (HCWs). The ways in which hospital hygiene could be improved are also discussed.

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Biological contamination events in isolators:What lessons can be learned?

James Drinkwater, Bioquell UK Process & Compliance Director.
Chairman of PHSS – Pharmaceutical & Healthcare Sciences Society.

Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. This paper considers a range of ‘real-life’ biological contamination event cases studies, reviews the root causes that were identified and looks at what lessons can be learned.

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Biological contamination events in isolators:Requirements and expectations

James Drinkwater, Bioquell UK Process & Compliance Director.
Chairman of PHSS – Pharmaceutical & Healthcare Sciences Society.

Bio-contamination found in critical zones within processing environments can affect the whole process and sterility of the final products, potentially putting patients at risk. This can lead to significant financial costs and impact operational resources. This white paper examines the regulatory environment around processing in a GMP and hospital pharmacy environment and looks at the importance of root cause investigation into biological contamination.

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Large-scale bio-decontamination with hydrogen peroxide vapour

Use of hydrogen peroxide vapour (HPV) is a recognised and recommended solution for the decontamination of small aseptic processing enclosures. Due to the historic limitations and lack of understanding of this technology, other larger scale applications have often not been considered. However, over the last 20 years Bioquell has developed world leading expertise in the bio-decontamination of large areas including hospitals, biomedical facilities, pharmaceutical production areas and bio-containment facilities. This paper discusses a service-based approach to large scale decontamination and the benefits hydrogen peroxide vapour technology can offer.

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Applications and integration of hydrogen peroxide vapour for biotech/bioprocess clients

Richard Lucas, Ph.D., Bioquell UK Ltd.

This white paper discusses the role and requirements of a modern bio-decontamination solution. It explores the key areas that need to be considered when seeking a solution and provides an illustration of the application of hydrogen peroxide vapour bio-decontamination technology within the biological production industry.

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Hydrogen peroxide decontamination: vapour vs. aerosolised systems

This white paper examines two different hydrogen peroxide-based room decontamination systems: hydrogen peroxide vapour (HPV) and aerosolised hydrogen peroxide (aHP).

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