Products

The Bioquell QUBE - Aseptic workstation for sterility test and pharmacy compounding

Bioquell QUBE
  • Modular aseptic processing solution in convenient configurations to meet your workflow
     
  • Air cleanliness ISO 5 and Grade A working environment with integrated Bioquell HPV 6-log bio-decontamination for peace of mind
     
  • Fast cycles and quick turnaround between tests - get more from your day.

Undertake aseptic processing in a Bioquell QUBE, a cost-effective modular aseptic workstation system with built- in rapid bio-decontamination.  The combination of uni-directional airflow, an ISO 5 and Grade A working environment and hydrogen peroxide vapour (HPV) rapid bio-decontamination ensures the Bioquell QUBE is suitable for applications such as pharmacy compounding, sterility testing, and many others. Performance is assured by using Bioquell approved hydrogen peroxide solution. The Bioquell QUBE modules allow a variety of configurations that tailor the workspace to the needs of the specific process.

Bioquell QUBE with extension module and aseptic pass out chamber

 

 

Bioquell QUBE with extension module and materials transfer device, ideal for phamaceutical compounding.


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Features

Key features
ISO 5 Grade A chamber with uni-directional air flow to meet the required regulatory standards for sample and operator protection.  User selectable for operating at -100 pa to +100pa depending on application requirements.  316 grade stainless steel floor with optional integrated sterility test pump

Ergonomically designed to maximize user comfort, the Bioquell QUBE has integrated foot switches for door operation, a foot rest and can be supplied with a height adjustable stool for optimum working conditions.  Glove ports supplied with safe change gloves for comfort and an optional easy to use in-built glove leak tester

Fast decontamination cycles for highest throughput and maximum responsiveness to support productivity in either sterility test or pharmaceutical compounding.  All features are operated from an intuitive, icon-driven built in touch screen.

Hydrogen peroxide is supplied in 150ml RFID tagged bottles for traceability and documentation is available through a printer incorporated into the system legs.  Also available with optimised chemical and biological indicators to ensure performance.

Available with a range of options for environmental monitoring to ensure best practice when processing samples through the system.

Benefits

Ergonomically designed using the latest manufacturing techniques, the Bioquell QUBE delivers rapid
bio-decontamination to a 6-log microbial reduction. It offers a high-level of security with flexibility and ease of use – designed to provide the best possible ‘fit’ for
your laboratory.

The Bioquell QUBE has been designed with a ‘plug and play’ philosophy using pre-engineered and pre-validated solutions to ensure minimal commissioning, ability to upgrade and unparalleled operator convenience.

Technical

 Physical and safety data

Dimensions (WxHxD)
Overall External:


Inside Chamber1:


1360 x 2329 x 843 mm
53.5 x 91.7 x 33.2 inch

1100 x 750 x 600 mm
43.3 x 29.5 x 23.6 inch
Weight 350 kg (772 lbs)

 
Operating data

Temperature limits Storage and operating 15-30°C (59-86°F)
Relative humidity limits
Storage 5-80% max - non condensing
Hydrogen peroxide liquid 30-35% w/w Bioquell approved supply only2
(Fits approved 150ml bottle with RFID)
Air Quality ISO 14644-1 Class 5 (EC GMP Annex 1 Grade A)

 
Power data:

Requirements 230v Single phase 50/60 Hz 5.7A
120v Single phase 50/60 Hz 10.9A
100v Single phase 50/60 Hz 13.0A
Consumption 1300 W (max)
Supply Installation category II
Cycle time Circ. 20 mins3

1 Chamber shape, may affect equipment location. For full chamber size & shape, please contact Bioquell
2 For a full hydrogen peroxide specification, please contact Bioquell or its agents
3 When using a single unit and depends on loading and absorbency of chamber contents

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.

Download

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.

Download

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.

Download

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.

Download

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