Risk Reduction Solutions for
Pharmaceutical, Life Sciences & Healthcare
Bioquell Qube – Pharmaceutical Isolator
The Bioquell Qube is a configurable isolator integrated with Bioquell’s Hydrogen Peroxide Vapor technology. From its unique design to optimized cycle times, the Bioquell Qube ensures your aseptic workspace needs are met for a productive working environment.
Ideal for:
- Sterility Testing
- Gene & Cell Therapy
- Small Batch Production
- Compounding
- Cytotoxic Preparation
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Advantages For Aseptic Manufacturing
Rapid
Bio-decontamination cycles optimized due to unique build; set-up from order to completed installation and validation in as few as 16 weeks
Adaptable
Up to three chambers (two gloves per chamber) and two material transfer areas to meet your workflow needs; positive and negative pressure capabilities
Assured
Customized validated cycles helping provide
ISO 5/EU Grade A environment; GMP compliance; unidirectional airflow in accordance with GMP Annex 1; 21-CFR Part 11 software available
Efficient
Four levels of environmental monitoring for your viable and nonviable particle needs; ability to incorporate the Merck Millipore Sigma Symbio Flex Sterility Pump; other distinctive options to keep you working efficiently
Integrated
Built-in Bioquell Hydrogen Peroxide Vapor technology for repeatable decontamination results; easy-to-use touch-screen; no HVAC connection required
Productive
Decontamination of materials in the main chamber while you work in another; aseptic-hold retention for typically seven days depending on your protocols
Pharma, Compounding, And Cell Therapy Solutions
Biotechnology & Drug Development
The strict and continual application of aseptic processing, environmental controls and monitoring are key to the approval and success of your final drug or product as a leading solution. With Bioquell’s automated, validated bio-decontamination, you have confidence in your bioburden elimination of your workspace and enhancements for sterility testing.
Gene & Cell Therapy
The risk and financial impact of microbial contamination is exceptionally high during the cell-production procedure, making aseptic conditions essential to the handling of cell samples. Performing as many steps as possible under isolation and following effective disinfection is the safest method. Our flexible bio-decontamination solutions allow you to maintain a secure, contaminant-free environment so you can develop and advance leading therapies and treatments.
Pharmaceutical Manufacturing & Compounding
Stringent manufacturing and compounding conditions call for leading bio-decontamination solutions. Whether operated by your staff members or one of our expert onsite technicians, our fixed and portable Hydrogen Peroxide Vapor bio-decontamination systems eliminate your airborne and surface contaminants in pass-throughs, airlocks and other areas for total working efficacy.
An Isolator With Multiple Configurations
The Bioquell Qube offers diverse applications and options ranging from one to three chambers with up to two optional exterior/material transfers.
The Bioquell Qube for Sterility Testing
Globally accepted with hundreds of chambers currently installed and in use with world leaders in biopharmaceutical, laboratory research and biotechnology, the Bioquell Qube delivers unparalleled efficiency, reliability and ease of implementation to your aseptic environment.
The Bioquell Qube for Cell Therapy
The Bioquell Qube offers a rapid and reliable aseptic environment that can be used in various stages of cell and gene therapy manipulation. See some examples of the Bioquell Qube's impact here.
Is your isolator ready for Annex 1 compliance?
Discover key details and how the Bioquell Qube offers compliance.
Download the Compliance ChecklistAccesories Preview
Environmental Monitoring
Aseptic environmental conditions with four monitoring modes ranging from manual to fully integrated particle monitoring with both viable and nonviable particle-counting options
Aseptic environmental conditions with four monitoring modes ranging from manual to fully integrated particle monitoring with both viable and nonviable particle-counting options
Up to two integrated Merck Millipore Steritest Symbio Flex sterility test pumps for improving your sterility test process, simplifying operations and freeing up workspace
The patented glove sleeve system remove all creases in both the sleeve and the glove when being decontaminated, and includes smaller and lighter Safe Change Cuff Rings. This design provides the reassurance that all areas of the Bioquell Qube are decontaminated.
Aseptic transfer of materials into and out of isolators with no break of containment or effect on ambient characteristics – available in both 190mm and 270mm
Contact us for more information about accessories in the Bioquell Qube to help optimize your workflow.
Contact UsExpert Isolator Validation
Our technical experts can install and validate the Bioquell Qube in as quickly as two weeks in most instances.
Because the Bioquell Qube is easy to maneuver, and fast to assemble, you often do not need any construction or electrical alterations to install. It can fit through 800mm (32-inch) door frames to be built directly in the designated area. It requires only a standard electrical outlet to function and, for positive pressure users, does not require connection to HVAC.
Validation includes training, installation, operational and performance qualification (IQ, OQ and PQ), validated cycles based on custom-load configurations, and all appropriate documentation.
FAQs
Will this offer 21-CFR Part 11 compliance?
Yes, we are able to offer an optional data logger for this purpose.
What is the internal floor of the Bioquell Qube made from?
The floor of the Bioquell Qube is constructed from 316 stainless steel to ensure resistance to scratching on the working surface.
If my processes or needs evolve, is it possible to modify the Bioquell Qube accordingly?
The Bioquell Qube has been designed to allow for certain upgrades to be easily added after installation, such as adding a glove tester, particle counter, active air sampling device, racking or material transfer device. These options can be budget-friendly and can enhance your system’s capabilities. If you have specific future needs in mind, let’s discuss them today to ensure we design a solution that meets your current and future requirements effectively.
How can I bring tubing or cables into the Bioquell Qube?
We have an option for fitting a floor-mounted one-inch triclover port in each chamber. This allows you to bring in liquid lines or cables securely into the body of the Bioquell Qube.
What sets the Bioquell Qube apart from traditional stainless steel options?
The Bioquell Qube is constructed of tough and hard-wearing polypropylene, which is resistant to most materials the unit is ever likely to come into contact with. Because of its construction, the Bioquell Qube can be installed and validated within 16 weeks and, in most cases with minimal invasiveness to your operation or workflow.
Can you set alarms for the temperature inside the Bioquell Qube?
Yes.
If I wish to change pressure from positive to negative, do I need to change the filters or take any additional action to ensure it is safe to use?
The Bioquell Qube can be switched between pressure regimes simply with the touch screen; no additional changes are needed.
Are there different leak tests programmed for the Bioquell Qube?
Yes, there are leak tests programmed for both positive and negative pressure.
Contact Us
To learn more about how Bioquell can fit your solution, please contact us.
The Americas
Ecolab Inc
702 Electronic Dr. Suite 200
Horsham, PA 19044
+1 215 682 0225
bioquellusorders@ecolab.com
