Bioquell Qube – Pharmaceutical Isolator

Ecolab’s Bioquell Qube provides an aseptic ISO 5/Grade A environment and includes integrated Bioquell Hydrogen Peroxide Vapor technology, achieving a validated 6-log sporicidal kill on exposed surfaces within operating areas.

From its polymer molding to its integration with Bioquell bio-decontamination technology, the Bioquell Qube is truly unique. Users can select from a 2, 4 or 6 glove configuration with up to 2 transfer chambers or rapid transfer ports (RTP’s) for transferring materials into and out of the Bioquell Qube. Its design allows for a small footprint with no required construction for installation.

With its standardized design and software, users receive consistent and uniform installation, validation service and support.

Technicians can stay efficient by performing critical tasks in a Grade A/ISO 5 environment while bio-decontaminating incoming supplies in an adjacent chamber in as little as 30 minutes.

A validated and operational system can be installed in your facility without construction, ductwork or additional electrical needs as the system requires only a standard outlet to function.

The Bioquell Qube can be located in a lower grade or Clean Non-Classified (CNC) area and is a key tool to help reduce the risks of contamination from operators and environment to critical aseptic processes while promoting regulatory compliance with GMP in mind.

Applications

• Sterility testing
• Small scale filling
• Cell and gene therapy drug development and manufacturing
• Pharmacy compounding
• Cytotoxic drug and sterile preparations (when selecting ducted option)
• Transfer isolator for large production isolators

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