The only isolator with Bioquell hydrogen peroxide vapor technology for rapid purification, reduced microbial contamination and significant cost savings
The Bioquell Group, one of the world's leading experts in the field of life sciences for microbial contamination risk reduction, highlighted its state-of-the-art Bioquell Qube aseptic platform at the 2018 ISCT Conference (International Conference of Cellular Therapy Associations). Suitable for the rapid rise of CAR-T, gene and cell therapy. Tailored to the individual needs of cell therapy development companies, hospitals and service providers, this isolator integrates Bioquell's advanced hydrogen peroxide vapor technology for rapid product purification, reduced microbial contamination and significant cost savings. client.
Bioquell isolators reduce the risk of microbial contamination
Bioquell's top isolator technology is ideal for handling key properties of CAR-T, gene and cell therapy, and can help reduce the potential risk of contamination by microorganisms or other patient cells due to human intervention. Since the operator can sit on the Qube workbench, this reform process allows the operator to work outside the cleanroom or buffer environment, but ensures that the production process is safe in an ISO 5/EU Class A environment. This also provides an extra level of protection against potentially high cost and dangerous microbial contamination.
The discovery of microbial contamination in key areas of the laboratory affects the entire genetic and cellular process and puts the patient's successful treatment at risk. This can result in significant financial cost losses and the impact of business resources. Therefore, regulators require biologic facilities to comply with Good Manufacturing Practice (GMP) management, and hope that manufacturers can be more proactive in microbial pollution control.
Advantages of Bioquell Qube Isolators over Traditional Isolators
Qube's unique design makes it far superior to traditional disinfection isolators for gene and cell therapy applications and provides an effective sterile environment for R&D & production processes. The system effectively helps reduce risk and supports the production of advanced biologics, which may allow more patients to receive treatment at the same time.
Using the Qube aseptic operating platform, Bioquell hydrogen peroxide vapor technology achieves better results in less time by instantly initiating a purification cycle. It does not require special temperature or humidity levels. When the purification process is initiated, its hydrogen peroxide vapor technology eliminates 99.9999% of the pathogens, resulting in a 6-log killing effect on each exposed surface.
With modularity and adaptability, the Bioquell Qube offers up to three cabins (two gloves per cabin) and an optional material transfer and fast transfer port (RTP) design to meet workflow requirements. It allows the material to be cleaned in one compartment while the operator is working in another, and the system can normally remain in a sterile seven-day environment, depending on the equipment agreement. Most units choose to purchase a cabin, and Bioquell can provide an option to add additional cabins based on capacity needs in the future.
Each Qube has a cabin with integrated hydrogen peroxide evaporator. The operator can choose to purify only this compartment space or open the connection channel to simultaneously purify adjacent pods. Bioquell Qube is able to perform thorough biological cleansing while working, and the staff can concentrate on the work at hand with peace of mind.
The Qube system provides four levels of environmental monitoring to meet all surviving and non-viable particle monitoring needs. It combines Merck Millipore's Sigma Symbio Flex sterility test pump with other unique work options to ensure maximum productivity.
Made of tough, abrasion-resistant polypropylene, the Bioquell Qube can be installed and verified in less than 12 weeks, with minimal disruption to the customer's operations/workflow. It provides a customized verification loop that provides GMP-compliant ISO 5/EU Class A environments and available 21-CFR Part 11 software.
The Qube comes with a wide range of advanced features, including a password-protected color touch screen control panel that allows for easy navigation through intuitive icons. With a proven loop and pre-programmed program, it can be started quickly and easily.
The Bioquell Qube is simple to install and is designed to pass through standard doors easily and easily. In addition, it does not require a ventilation system, it can switch between negative and positive pressure, and only requires a standard power outlet, so the power consumption is almost negligible.
Optional accessories such as sterile test pumps, environmental monitoring modules and shelves are easily embedded in the isolator and maintain an easy-to-operate workspace.
Bioquell's advanced isolator manufacturing process ensures increased product consistency and reduced product manufacturing and lead times. This means we can provide customized solutions to our customers faster.
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